Final Visit Research Articles

A new portable negative pressure wound therapy device: a prospective study investigating clinical outcomes.

Closed surgical incision sites at high risk of complications, and with exudate or leakage, are increasingly being managed with closed incision negative pressure wound therapy (ciNPWT) to reduce tissue stress and increase the force necessary to disrupt the incision. This study was undertaken to investigate the performance and safety of a canister-based, single-use NPWT (suNPWT) system when used on closed surgical incision sites. The investigation was designed as a prospective, open, non-comparative, multicentre study aimed at confirming the safety and performance attributes of the suNPWT system when applied to low-to-moderately exuding closed surgical incisions. The primary performance measure was the wound remaining closed from baseline to the last follow-up visit on day 14. Secondary performance measures included: wound and periwound condition; wear time of the system; product consumption; adherence to therapy; and patients' pain progress. Details of adverse events were also collected. Some 35 patients were recruited. The closed surgical incisions responded well to treatment with the tested suNPWT system. All wounds remained closed throughout the investigation. Consistent with other studies of ciNPWT reporting low infection rates, the current study observed either no or low exudation in 90.4% of wounds at the final visit, together with absence of surgical site infection. Pain severity levels were low, both at dressing change and during delivery of negative pressure. No serious adverse device events were reported. In this study, the suNPWT system supported the healing of closed surgical incisions with no safety concerns relating to its use.

Percutaneous repair of achilles tendon ruptures: short-term results of 41 patients

Aims: Despite the current popularity of surgical treatment of Achilles tendon ruptures, there is no clear consensus about which technique should be applied. The aim of this study is to evaluate the short- to mid-term results of acute Achilles tendon ruptures treated with the percutaneous method and to discuss these results in light of the literature. Methods: In this study, 41 patients who were operated on percutaneously with the diagnosis of acute Achilles tendon rupture between 2016 and 2019, whose treatment was completed, and who had a follow-up period of at least 1 year were included. At the patients’ final follow-up visits, the range of motion of the ankle joint, time to return to work and sports, and complications were evaluated. For functional evaluations, the scoring system of the American Orthopaedic Foot & Ankle Society (AOFAS) for the ankle joint was used. Results: The mean age of the patients was 29.3 (18-50) years and the mean follow-up duration was 23 (12-38) months. The mean dorsiflexion angle was 32.27° (20-45°) and the mean plantar flexion angle was 34.58° (20-45°). The time to return to work was 14.2 (8-21) weeks, while time to return to sports was 30.4 (17-49) weeks. The mean AOFAS score of the patients was 91.63 (74-100). The complications included infection in 2 (4.8%) patients, wound necrosis in 1 (2.4%) patient, re-rupture in 1 (2.4%) patient, and sural nerve neuropraxia in 1 (2.4%) patient. Conclusion: The findings of this study suggest that percutaneous repair is an effective method in the treatment of acute Achilles tendon ruptures, like other surgical methods that offer good functional results with low complication rates.

Safety and tolerability of tegoprubart in patients with amyotrophic lateral sclerosis: A Phase 2A clinical trial.

The interaction of CD40L and its receptor CD40 on activated T cells and B cells respectively control pro-inflammatory activation in the pathophysiology of autoimmunity and transplant rejection. Previous studies have implicated signaling pathways involving CD40L (interchangeably referred to as CD154), as well as adaptive and innate immune cell activation, in the induction of neuroinflammation in neurodegenerative diseases. This study aimed to assess the safety, tolerability, and impact on pro-inflammatory biomarker profiles of an anti CD40L antibody, tegoprubart, in individuals with amyotrophic lateral sclerosis (ALS). In this multicenter dose-escalating open-label Phase 2A study, 54 participants with a diagnosis of ALS received 6 infusions of tegoprubart administered intravenously every 2 weeks. The study was comprised of 4 dose cohorts: 1 mg/kg, 2 mg/kg, 4 mg/kg, and 8 mg/kg. The primary endpoint of the study was safety and tolerability. Exploratory endpoints assessed the pharmacokinetics of tegoprubart as well as anti-drug antibody (ADA) responses, changes in disease progression utilizing the Revised ALS Functional Rating Scale (ALSFRS-R), CD154 target engagement, changes in pro-inflammatory biomarkers, and neurofilament light chain (NFL). Seventy subjects were screened, and 54 subjects were enrolled in the study. Forty-nine of 54 subjects completed the study (90.7%) receiving all 6 infusions of tegoprubart and completing their final follow-up visit. The most common treatment emergent adverse events (TEAEs) overall (>10%) were fatigue (25.9%), falls (22.2%), headaches (20.4%), and muscle spasms (11.1%). Mean tegoprubart plasma concentrations increased proportionally with increasing dose with a half-life of approximately 24 days. ADA titers were low and circulating levels of tegoprubart were as predicted for all cohorts. Tegoprubart demonstrated dose dependent target engagement associated and a reduction in 18 pro-inflammatory biomarkers in circulation. Tegoprubart appeared to be safe and well tolerated in adults with ALS demonstrating dose-dependent reduction in pro-inflammatory chemokines and cytokines associated with ALS. These results warrant further clinical studies with sufficient power and duration to assess clinical outcomes as a potential treatment for adults with ALS. Clintrials.gov ID:NCT04322149.

Effect of spironolactone wash-out on albuminuria after long-term treatment in individuals with type 2 diabetes and high risk of kidney disease-An observational follow-up of the PRIORITY study.

This study aimed to explore the effect of discontinuation of long-term spironolactone treatment on markers of kidney function in individuals with type 2 diabetes (T2D) at high risk of kidney disease enrolled in the Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria (PRIORITY) study. An observational study following the nested randomised part of the PRIORITY study was conducted. A total of 115 individuals with T2D and normoalbuminuria but high risk for progression based on urinary proteomics, randomised to daily spironolactone (n = 50) or placebo (n = 65) for a median of 2.5 years, were re-examined approximately 6 weeks after the final visit in the PRIORITY study. Primary endpoint was relative change in geometric mean of urinary albumin-creatinine ratio (UACR) between the final visit in PRIORITY (baseline) and follow-up. Secondary endpoints were change in estimated glomerular filtration rate (eGFR), systolic blood pressure (SBP) and serum potassium. No change in UACR was observed in neither the spironolactone (geometric mean change: 17%; 95% CI -12, 55; p = 0.28) nor the placebo (5%; 95% CI -13, 26; p = 0.63) group at follow-up. No difference in UACR between the groups was observed at follow-up (relative difference in geometric mean: 11%, 95% CI -26, 67; p = 0.60). For eGFR and SBP, an increase after discontinuation of spironolactone was observed, as well as for SBP after placebo discontinuation. Potassium levels were lower after discontinuation of spironolactone, but higher after placebo discontinuation (all p < 0.05). UACR did not change after discontinuation of long-term treatment with spironolactone. However, an increase in eGFR was observed supporting a haemodynamic effect of spironolactone in the kidneys.

Evaluating the Effectiveness of Ahmed Glaucoma Valve Implantation in Reducing Intraocular Pressure in Refractory Glaucoma in the Saudi Arabian Population at a Tertiary Care Centre

Objectives: To assess the efficacy of Ahmed glaucoma valve implantation (AGVI) in lowering intraocular pressure (IOP) in patients with refractory glaucoma. Methods: In this retrospective study, we analyzed the medical records of 60 patients who received AGVI for refractory glaucoma. Data collected included demographics, type of glaucoma, preoperative and postoperative IOP, number of glaucoma medications, and any surgical complications. Success was defined as achieving an IOP &lt;21 mmHg at the final follow-up visit. Results: At the final follow-up (mean duration of 11.6 months), AGVI achieved successful IOP control (IOP of &lt;21 mmHg) in 40 eyes (66.7%). The mean number of glaucoma medications decreased significantly from 2.95 preoperatively to 1.98 postoperatively (p &lt; 0.001). Neovascular glaucoma (NVG) had a lower success rate compared to other types of glaucoma. Prior glaucoma surgery was associated with a higher risk of failing to reach target IOP, although this trend was not statistically significant (p = 0.108). Conclusion: AGVI implantation effectively lowered IOP in patients with refractory glaucoma, especially in the short term. However, long-term success rates were lower, and NVG showed less favorable outcomes. AGVI is a valuable option for managing refractory glaucoma, but careful patient selection is essential. Further research is needed to evaluate long-term efficacy and refine treatment strategies.

Analysis of preoperative and postoperative depression and anxiety in patients with lumbar disc herniation with radiculopathy treated with percutaneous transforaminal endoscopic discectomy

ObjectiveThis study aims to examine the mental health of patients with lumbar disc herniation with radiculopathy (LDHR) and to evaluate the effects of percutaneous transforaminal endoscopic discectomy (PTED) on their mental well-being.MethodThis study included 114 LDHR patients who received PTED in the Spinal Orthopedics Department of Zhongshan Hospital of Traditional Chinese Medicine between May 2022 and May 2023. The study population was stratified into two groups according to the presence of preoperative anxiety and depression: Group A comprised patients with such symptoms, and Group B included the remainder. Patients were assessed using the Hospital Anxiety and Depression Scale (HADS), the Visual Analog Scale for Pain (VAS), and the Oswestry Disability Index (ODI) at preoperative and final follow-up visits. Evaluations were performed using the Hospital Anxiety and Depression Scale (HADS), the Visual Analog Scale, and the Oswestry Disability Index (ODI) at the time of preoperation and during the last follow-up.ResultsAmong the 114 LDHR patients who obtained complete follow-up, fifty-four had anxiety/depression symptoms before surgery, which accounted for a incidence of 47%. Both Group A and Group B patients showed significant improvement in all evaluation indicators after PTED, but the overall prognosis of Group A was worse than that of Group B.ConclusionPTED can effectively improve patients’ pain, functional activities and mental health, which has a positive impact on patients’ quality of life, and there is a significant correlation between patients’ preoperative mental health and prognosis.

Mexican Hispanics show significant improvement in lung function approximately 1year after having severe COVID-19.

The long-term effects of COVID-19 on lung function are not understood, especially for periods extending beyond 1year after infection. This observational, longitudinal study investigated lung function in Mexican Hispanics who experienced severe COVID-19, focusing on how the length of recovery affects lung function improvements. At a specialized COVID-19 follow-up clinic in Yucatan, Mexico, lung function and symptoms were assessed in patients who had recovered from severe COVID-19. We used z-scores, and Wilcoxon's signed rank test to analyse changes in lung function over time. Lung function was measured twice in 82 patients: the first and second measurements were taken a median of 94 and 362days after COVID-19 diagnosis, respectively. Initially, 61% of patients exhibited at least one of several pulmonary function abnormalities (lower limit of normal = -1.645), which decreased to 22% of patients by 390days post-recovery. Considering day-to-day variability in lung function, 68% of patients showed improvement by the final visit, while 30% had unchanged lung function from the initial assessment. Computed tomography (CT) scans revealed ground-glass opacities in 33% of patients. One year after infection, diffusing capacity of the lungs for carbon monoxide z-scores accounted for 30% of the variation in CT fibrosis scores. There was no significant correlation between the length of recovery and improvement in lung function based on z-scores. In conclusion, 22% of patients who recovered from severe COVID-19 continued to show at least one lung function abnormality 1year after recovery, indicating a prolonged impact of COVID-19 on lung health.

The effect of phacoemulsification on the intraocular pressure, anterior chamber and pupildiameter in patients with pseudoexfoliation syndrome

Aims: To evaluate the effect of phacoemulsification on the intraocular pressure, anterior chamber and pupil diameter in patients with pseudoexfoliation syndrome. Methods: 66 eyes of thirty-three patients who had pseudoexfoliation and underwent phacoemulsification enrolled in this retrospective study. The eyes divided two groups as a study group that with Pseudoexfoliation Syndrome (PES) or Pseudoexfoliation (PEX) glaucoma and the other eyes as a control group without PES or PEX glaucoma. The follow-up examinations were preoperatively and postoperatively on the first day, fourth day, first month, and three months. Best-Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), Anterior Chamber Depth (ACD) and Pupil Diameter (PD) were evaluated at each visit, and glaucoma medications were noted. Results: There was no statistically significant difference when compared preoperative and postoperative IOP values on the first day between two groups (p&gt;0.05). The mean IOP postoperatively at 4th, 30th day and 3rd months, reduced according to preoperative values in the study group (P&lt;0.05). Mean anterior chamber depth and pupil diameter were increased significantly at the final visit (p&lt;0.001). Conclusion: Cataract surgery has a beneficial effect on patients with PEX including IOP, ACD and PD.

The difference in clinical characteristics between patients with rhegmatogenous retinal detachment during partial and complete lock-down periods related to COVID-19 pandemics 2-year long follow-up results

BackgroundWe aimed to compare results of clinical presentation of rhegmatogenous retinal detachment (RRD), and the surgical approach during partial or complete lock-down periods (LP), and non-COVID periods in a tertiary ophthalmology clinic.MethodsThe medical data of the patients who were diagnosed with RRD in a tertiary hospital. The demographic data of patients, the duration from the beginning of the visual symptoms to hospital admission, the status of lens, the anatomical quadrant of retinal break, best-corrected visual acuity (BCVA) at presentation, the type of intraocular tamponade, and final BCVA were recorded. The exclusion criteria were RD other than rhegmatogenous (tractional or exudative), and incomplete follow-up until 2nd-year.ResultsThe study included 20 eyes of 20 RRD cases in partial LP, 20 eyes of 20 RRD cases in complete LP, and 23 eyes of 23 RRD cases in non-COVID period. The ratio of perfluoropropane (C3F8) gas to silicone oil which was applied as intraocular tamponade at the end of the surgery for RRD was 15/8 in non-COVID period, 11/9 in partial LP, and 11/9 in complete LP (p = 0.730). In final visit at postoperative 2nd-year, the BCVA was logMAR 0.613 ± 0.425 in non-COVID period, logMAR 0.668 ± 0.348 in partial LP, and logMAR 0.730 ± 0.368 in complete LP (p = 0.612). In both inferior and superior quadrant RD, there was significant difference between baseline and final BCVA after surgery. (Baseline and final BCVA in inferior RD: logMAR 1.71 ± 0.40, and logMAR 0.950 ± 0.30 (p = 0.011) and, in superior RD: logMAR 1.35 ± 0.59, and logMAR 0.505 ± 0.321 (p = 0.0001), respectively.)ConclusionsAs a result, it seems that both partial and complete LP did not modify the typology of RRD surgeries.Trial registrationRetrospectively registered. The study followed the tenets of the Declaration of Helsinki, and it was approved by the local ethical committee (2023-088).

Comparison of Iridex MP3 and P3 probes on long-term intraocular pressure control after MicroPulse Transscleral-Cyclophotocoagulation

PurposeMicropulse transscleral cyclophotocoagulation (MP-TSCPC) is a glaucoma procedure that delivers energy to the ciliary body with minimal collateral-damage. We aim to assess the long-term effectiveness of MP-TSCPC using the original MP3 and revised P3 probe. Methods and designBaseline Retrospective cohort study was performed to obtain baseline characteristics, intraocular pressure (IOP), number of IOP-lowering medications, and best-corrected visual acuity (BCVA) were obtained from pre- and post-operative visits of patients treated with MP-TSCPC. Failure was defined as IOP>21 mmHg, reduced IOP<20% below baseline, or IOP<5 mmHg on 2 consecutive follow-up visits after post-operative month 1, reoperation for glaucoma, or loss of vision to no light perception. ResultsA total of 113 eyes were enrolled, 44 using the MP3 probe and 69 with the revised P3 probe. Survival analysis found a 75% failure rate in patients treated with the revised P3 probe by the final visit with a mean time to failure (MTTF) of 4.8 ± 0.7 months which was higher than the original probe at 66% failure rate with a MTTF of 6.1 ± 1.1 months (p = 0.04). All causes of failure were due to high IOP and 67% required repeat treatment with MP-TSCPC or incisional surgery. Prior to censure of data from failure, both probes had significant reduction in IOP compared to pre-operative IOP at all time points. No significant changes in BCVA were found. Both groups were associated with low rates of complications. ConclusionBoth probes had a very low rate of visually significant complications when performed in a standardized method in accordance with surgical procedure and power settings recommended by Iridex; however, were associated with a high rate of single procedure failure due to uncontrolled IOP over the long term. The revised P3 probe was associated with a higher rate of failure. Patients experienced a reduction in IOP; however, a large proportion required additional treatment compared to the original MP3 probe.

5-year vaccine protection following a single dose of Vi-tetanus toxoid conjugate vaccine in Bangladeshi children (TyVOID): a cluster randomised trial

WHO currently recommends a single dose of typhoid conjugate vaccine (TCV) in high-burden countries based on 2-year vaccine efficacy data from large randomised controlled trials. Given the decay of immunogenicity, the protection beyond 2 years is unknown. We therefore extended the follow-up of the TyVAC trial in Bangladesh to assess waning of vaccine protection to 5 years after vaccination. We conducted a cluster randomised controlled trial (TyVAC; ISRCTN11643110) in Dhaka, Bangladesh, between 2018 and 2021. Children aged 9 months to 15 years were invited to receive a single dose of TCV or Japanese encephalitis vaccine between April 15, 2018, and November 16, 2019, based on the randomisation of their clusters of residence. Children who received the Japanese encephalitis vaccine were invited to receive TCV at the final visit between Jan 6, and Aug 31, 2021, according to the protocol. This follow-on study extended the follow-up of the original trial until Aug 14, 2023. The primary endpoint of this study was to compare the incidence of blood culture-confirmed typhoid between children who received TCV in 2018-19 (the previous-TCV group) and those who received the vaccine in 2021 (the recent-TCV group), to evaluate the relative decline in vaccine protection. We also did a nested study using the test-negative design comparing the recent-TCV and previous-TCV groups with unvaccinated individuals, as well as an immunogenicity study in a subset of 1500 children. Compared with the recent-TCV group, the previous-TCV group had an increased risk of typhoid fever between 2021-23, with an adjusted incidence rate ratio of 3·10 (95% CI 1·53 to 6·29; p<0·0001), indicating a decline in the protection of a single-dose of TCV 3-5 years after vaccination. The extrapolated vaccine effectiveness in years 3-5 was 50% (95% CI -13 to 78), and was validated using the test-negative design analysis, with a vaccine effectiveness of 84% (74 to 90) in the recent-TCV group and 55% (36 to 68) in the previous-TCV group, compared with unvaccinated individuals. Anti-Vi-IgG responses declined over the study period. The highest rate of decay was seen in children vaccinated at younger than 2 years in the original trial. The inverse correlation between age and the decay of antibodies was also seen in the subgroup analysis of vaccine effectiveness, where the youngest age group (<7 years at fever visits) exhibited the fastest waning, with vaccine effectiveness dropping to 24% (95% CI -29 to 55) at 3-5 years after vaccination. A decline in the protection conferred by a single-dose TCV was observed 3-5 years after vaccination, with the greatest decline in protection and immune responses observed in children vaccinated at younger ages. A booster dose of TCV around school entry age might be needed for children vaccinated while younger than 2 years to sustain protection against typhoid fever during the school years when the risk is the highest. The Bill & Melinda Gates Foundation.

Artificial Intelligence-Enhanced OCT Biomarkers Analysis in Macula-off Rhegmatogenous Retinal Detachment Patients.

To identify optical coherence tomography (OCT) biomarkers for macula-off rhegmatogenous retinal detachment (RRD) with artificial intelligence (AI) and to correlate these biomarkers with functional outcomes. Patients with macula-off RRD treated with single vitrectomy and gas tamponade were included. OCT volumes, taken at 4 to 6 weeks and 1 year postoperative, were uploaded on an AI-derived platform (Discovery OCT Biomarker Detector; RetinAI AG, Bern, Switzerland), measuring different retinal layer thicknesses, including outer nuclear layer (ONL), photoreceptor and retinal pigmented epithelium (PR + RPE), intraretinal fluid (IRF), subretinal fluid, and biomarker probability detection, including hyperreflective foci (HF). A random forest model assessed the predictive factors for final best-corrected visual acuity (BCVA). Fifty-nine patients (42 male, 17 female) were enrolled. Baseline BCVA was 0.5 logarithmic minimum angle of resolution (logMAR) ± 0.1, significantly improving to 0.3 ± 0.1 logMAR at the final visit (P < 0.001). Average thickness analysis indicated a significant increase after the last follow-up visit for ONL (from 95.16 ± 5.47µm to 100.8 ± 5.27µm, P = 0.0007) and PR + RPE thicknesses (60.9 ± 2.6µm to 66.2 ± 1.8µm, P=0.0001). Average occurrence rate of HF was 0.12 ± 0.06 at initial visit and 0.08 ± 0.05 at last follow-up visit (P=0.0093). Random forest model revealed baseline BCVA as the most critical predictor for final BCVA, followed by ONL thickness, HF, and IRF presence at the initial visit. Increased ONL and PR-RPE thickness associate with better outcomes, while HF presence indicates poorer results, with initial BCVA remaining a primary visual predictor. The study underscores the role of novel biomarkers like HF in understanding visual function in macula-off RRD.

Prevention of Infectious Complications in Acute Pancreatitis

AIM OF STUDY. The study was aimed to evaluate the effectiveness of treating acute pancreatitis by early enteral nutrition and selective introduction of nutritional mixtures directly into the initial sections of the jejunum, bypassing the duodenum.MATERIAL AND METHODS. A comprehensive treatment method for acute pancreatitis was developed based on the use of a pancreatoduodenal catheter. The method focuses on preventing intestinal failure syndrome by isolating the duodenum and preventing any liquid from entering it while ensuring the selective introduction of glucose-saline solutions and/or enteral nutritional mixtures directly into the initial sections of the jejunum. Several Russian clinics are currently conducting the research approved by local ethics committees. This article presents preliminary results from the data analysis. The study included moderate to severe forms (according to the 2012 Atlanta classification) of acute biliary pancreatitis without indications for endoscopic retrograde cholangiopancreatography, as well as alimentary-alcoholic pancreatitis. The first group of patients received standard therapy according to the 2020 clinical guidelines of the Russian Society of Surgeons. The second group received standard therapy combined with the new selective enteral nutrition method. The observation period lasted until the end of the hospital treatment, including five mandatory visits and a final visit to the physician. A follow-up survey was conducted three months or more after discharge to identify delayed episodes of acute pancreatitis complications, focusing on the incidence of infectious complications and surgical interventions.RESULTS. A total of 148 patients were treated. Patients were evenly distributed by etiology, gender, age, and body mass index. The analysis revealed that the number of patients with infectious complications decreased from 19.3% in the comparison group to 6.67% in the study group (p=0.041). The number of patients requiring surgical interventions was 5.0% in the study group compared to 19.3% in the comparison group (p=0.017).CONCLUSIONS. The study demonstrated that the use of the new method in the comprehensive treatment of acute pancreatitis, including early enteral feeding at the onset of the disease, may improve the course of the disease by reducing the incidence of infectious complications and the number of necessary surgical interventions.

Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide

Background: Non-arteritic anterior ischemic optic neuropathy is the most common acute optic neuropathy in patients older than 50 years. Risk factors for NAION are structural crowding of disc, diabetes, systemic hypertension, hyperlipidaemia, smoking. Patients present with sudden monocular vision loss, dyschromatopsia, visual field defect, disc edema diffuse or segmental. Objectives: To evaluate risk of non arteritic anterior ischemic optic neuropathy after routine treatment. Method: This Longitudinal observational study was carried out from January 2016 to June 2016 at Department of Neuro-Ophthalmology, National Institute of Ophthalmology &amp; Hospital, Sher -E-Bangla Nagar, Dhaka among Sixty cases. Detailed information were obtained in each cases according to protocol. A complete history was taken from the patient. Relevant investigation reports were collected. Selected patients were undergone detailed ophthalmological and systemic evaluation. They were treated at NIO&amp;H with following measure like proper counseling, controlling of risk factors like diabetes, hypertension, hyperlipidaemia and were advised to take tablet vitamin B1, B6 &amp; B12. They were followed up at 1st week, 4th week &amp; 8th week. In each visit visual acuity, color vision, field of vision, RAPD &amp; optic disc changes were recorded in a pre- designed data collection sheet. All the information’s were recorded according to fixed protocol. Results: Among the 60 cases, mean age was 55.67 (±4.89) years, minimum age was 51 and maximum age 69 years. Majority 32(53.3%) were male and 28(46.67%) were female. Associated risk factor like diabetes, hypertension, hyperlipidaemia and sleep apnea which were 53.3%, 36.67%, 30% and 13.3% respectively. Different disc changes of the study population were segmental disc swelling 36(60%) and diffuse disc swelling 24(40%) respectively. Regarding distant visual acuity patients were grouped into 6/6 to 6/12 group, 6/18-6/36 group, 6/60- 1/60 group and counting finger to hand movement group. At presentation most of the patient belongs to 6/6- 6/12 group which was 26(43.33%) followed by 6/18-6/36 group, it was 18(30%), 10(16.67%) were included in (6/60-1/60) group and the rest 06(10%) were included in counting finger to hand movement group. At final visit on 8th week 20(35.7%) patients remain in 6/6-6/12 group and also 6/18-6/36 group includes 20(35.7%) patients, 10(16.67%) were included in (6/60-1/60) group and the rest 06(10%) were included in counting finger to hand movement group. RAPD present in pretreatment 52(86.7%) and in post treatment were 46(82.14%). (p&gt;0.05) that was not statistically significant. Color vision dyschromatopsia in pretreatment 46(76.7%) and in post treatment were 37(60%). In post treatment 06(10.71%) were normal color vision. (p&lt;0.5) that was statistically significant. ocular involvement 52(86.67%) were 1st eye and 08(13.3%) were 2nd eye. Comparison of pre-treatment and post treatment visual field were Arcuate scotoma 12(20%) vs 09(16.07%), Inferior Altitudinal field defect 32(53.33%) vs 31(57.14%), Superior Altitudinal field defect 02(3.3%) vs 02(3.57%) respectively. Conclusion: In study no significant change found on visual acuity, colour vision and field of vision after treatment of non-arteritic anterior ischemic optic neuropathy.

Use of Continuous Oral Drospirenone for Menstrual Suppression in Adolescents

PurposeTo describe experiences of adolescents taking continuous drospirenone (DRSP-C) oral contraceptives, without placebo, for menstrual suppression, including breakthrough bleeding and other side-effects. MethodsThis was a retrospective chart review of adolescents prescribed DRSP-C for menstrual suppression. Demographics and indications for DRSP-C were collected on the visit where DRSP-C was prescribed. Data through the final follow-up visit during the study period included documented effects and side-effects of DRSP-C and continuation of therapy. Statistical analyses were primarily descriptive. ResultsPatients prescribed DRSP-C were included (n = 136). Dysmenorrhea was the most common indication for DRSP-C (58.8%, n = 80/136) followed by endometriosis (44.8%, n = 61/136). The median time on DRSP-C for the 116 patients who were able to initiate treatment was 12.3 months (interquartile range [IQR] 6.8, 17.4). Patients trialed, on average, 2 other forms of menstrual management before starting DRSP-C (IQR 1, 3). Pelvic pain or dysmenorrhea resolution or improvement was reported in 84.6% (44/52) of dysmenorrhea patients, and 77.8% (28/36) of pelvic pain patients. Almost half of patients reported breakthrough bleeding on DRSP-C (41.3%, n = 48/116); however, only 11 patients (42%, 11/26) discontinued DRSP-C because of it. Within the study period, 22.4% (n = 26/116) of patients discontinued DRSP-C, with a median treatment duration of 101 days (IQR 71, 157). Among patients who discontinued DRSP-C, the most common reason was breakthrough bleeding (42%, n = 11/26). DiscussionDRSP-C for menstrual suppression was well tolerated in adolescents, with most patients reporting resolution or improvement of their indication for taking DRSP-C. Findings demonstrate DRSP-C is a viable option for menstrual suppression in adolescents.

The impact of Medicaid expansion under the Affordable Care Act on HIV care continuum outcomes across the United States.

HIV care continuum outcome disparities by health insurance status have been noted among people with HIV (PWH). We therefore examined associations between state Medicaid expansion and HIV outcomes in the United States. Adults (≥18 years) with ≥1 visit in NA-ACCORD clinical cohorts from 2012-2017 contributed person-time annually between first and final visit or death; in each calendar year, clinical retention was ≥2 completed visits > 90 days apart, antiretroviral therapy (ART) receipt was receipt of ≥3 antiretroviral agents, and viral suppression was last measured HIV-1 RNA < 200 copies/mL. CD4 at enrollment was obtained within 6 months of enrollment in cohort. Difference-in-difference (DID) models quantified associations between Medicaid expansion changes (by state of residence) and HIV outcomes. Across 50 states, 87 290 PWH contributed 325 113 person-years of follow-up. Medicaid expansion had a substantial positive effect on CD4 at enrollment (DID = 93.5, 95% CI: 52.9, 134 cells/mm3), a small negative effect on proportions clinically retained (DID = -0.19, 95% CI: -0.037, -0.01), and no effects on ART receipt (DID = 0.001, 95% CI: -0.003, 0.005) or viral suppression (DID = -0.14, 95% CI: -0.34, 0.07). Medicaid expansion had a positive effect on CD4 at entry, suggesting more timely HIV testing and care linkage, but generally null effects on downstream HIV care continuum measures.

6822 Proptosis Improvement with Teprotumumab is Independent of Race, Ethnicity, Gender and Age from Three Global Randomized, Double-Masked, Placebo-Controlled Trials of Patients with Acute Thyroid Eye Disease (TED)

Abstract Disclosure: G.J. Kahaly: Consulting Fee; Self; Amgen Inc. Research Investigator; Self; Amgen Inc. S.T. Wester: Advisory Board Member; Self; Amgen Inc. Consulting Fee; Self; Immunovant, Lassen. Research Investigator; Self; Amgen Inc, Sling Therapeutics, Immunovant. C.Y. Liu: Other; Self; royalties from Wolters Kluwers Health. H. Kate: Employee; Self; Amgen Inc. Stock Owner; Self; Amgen Inc. E. Conrad: Employee; Self; Amgen Inc. Stock Owner; Self; Amgen Inc. R.J. Holt: Employee; Self; Amgen Inc. Stock Owner; Self; Amgen Inc. Y. Hiromatsu: Advisory Board Member; Self; Amgen Inc. Consulting Fee; Self; Amgen Inc. Research Investigator; Self; Amgen Inc. Introduction: Thyroid eye disease (TED) produces orbital tissue expansion, inflammation, proptosis (eye bulging) and diplopia (double vision), causing eye pain and appearance/visual changes. Teprotumumab, an insulin-like growth factor-1 receptor inhibitor, significantly improved signs and symptoms of TED in three placebo-controlled trials in patients with high inflammation. Here, we report pooled proptosis response in patient subgroups. Methods: Patients ≥18 years old from three placebo-controlled trials, two in the US and EU (NCT01868997, NCT03298867) and one in Japan (OPTIC-J; jRCT2031210453), with Graves’ disease and recent onset (≤9 month duration) active TED (Clinical activity score, CAS≥4, ≥3 for OPTIC-J) were included. Patients received eight infusions of teprotumumab or placebo over 21 weeks, with the final study visit at Week 24 (three weeks after final dose). Observed proptosis response, defined as ≥2 mm improvement from baseline in study eye without deterioration ≥2 mm in fellow eye at Week 24, versus placebo is reported by tobacco use (yes/no), race (White or Asian), and age (&amp;lt;65/≥65). Cochran-Mantel-Haenszel tests compared teprotumumab and placebo subgroups. Results: Of 111 teprotumumab and 114 placebo patients, 68.5% (76) and 76.3% (87) were female, respectively; mean (SD) age 50.3 (12.4) and 51.1 (13.1) years, respectively; mean (SD) TED duration 5.49 (2.32) and 5.98 (2.40) months, respectively; and 78.4% (87) and 73.7% (84) were never/former smokers, respectively. In the overall population, 80.2% (89/111) of teprotumumab patients and 14.0% (16/114) of placebo patients had a proptosis response (P&amp;lt;.0001). At Week 24, 70.8% (17/24) of teprotumumab and 23.3% (7/30) placebo smokers were proptosis responders; in non-smokers, 82.8% (72/87) of teprotumumab and 10.7% (9/84) placebo patients were proptosis responders (P&amp;lt;.0001 for both). In White patients, 78.9% (56/71) of teprotumumab and 15.8% (12/76) of placebo patients were proptosis responders; in Asian patients, 90.0% (27/30) of teprotumumab and 10.0% (3/30) of placebo patients were responders (P&amp;lt;.0001 for both). In patients &amp;lt;65 years, 79.2% (76/96) teprotumumab patients and 13.4% (13/97) placebo patients were responders; in patients ≥65 years, 86.7% (13/15) teprotumumab and 17.6% (3/17) placebo were responders (P&amp;lt;.0001 for both). Conclusions: Subgroup analysis of proptosis response by tobacco use, race, and age showed that teprotumumab treatment led to significantly higher proptosis response versus placebo in all groups. Public Presentation: 6/1/2024

6807 Evaluation of Tobacco Exposure and Teprotumumab Efficacy: Pooled Results from Acute TED Clinical Trials

Abstract Disclosure: S. Ugradar: Consulting Fee; Self; Acelyrin. S.T. Wester: Advisory Board Member; Self; Amgen Inc. Consulting Fee; Self; Immunovant, Lassen. Research Investigator; Self; Amgen Inc, Sling, Immunovant. R. Holt: Employee; Self; Amgen Inc. Stock Owner; Self; Amgen Inc. Q. Fu: Employee; Self; Amgen Inc. Stock Owner; Self; Amgen Inc. G.J. Kahaly: Consulting Fee; Self; Amgen Inc. Research Investigator; Self; Amgen Inc. Introduction: Tobacco exposure is a known risk factor for Thyroid Eye Disease (TED) development and severity. Here, we compare outcomes with teprotumumab in smokers versus non-smokers as reported in pooled clinical trials in patients with acute TED. Methods: Patients ≥18 years old from two placebo-controlled trials and an open-label extension in the US and EU (Phase 2, NCT01868997; OPTIC, NCT03298867; OPTIC-X, NCT03461211) and one placebo-controlled trial in Japan (OPTIC-J, jRCT2031210453) with Graves’ disease and recent onset (≤9 month duration) active TED (Clinical activity score, CAS≥4), were included. Patients received eight infusions of teprotumumab over 21 weeks, with the final study visit at Week 24 (three weeks after final dose). Statistical analyses were conducted to test differences in responder rates for proptosis (≥2mm, primary outcome), diplopia (Bahn-Gorman scale≥1), clinical activity score (CAS, 2-point improvement), and Overall response (proptosis + CAS), as well as proptosis mm change and Graves’ Ophthalmopathy Quality of Life (GO-QOL, range 0-100) score change. Cochran-Mantel-Haenszel tests were conducted to test the difference in responder rate for proptosis, diplopia, CAS, and Overall responder rate between smokers and non-smokers stratified by study (Phase 2, OPTIC, OPTIC-X, and OPTIC-J). Mixed Model for Repeated Measures was conducted to test the difference in the mean change in proptosis and GO-QOL. Results: Baseline characteristics and TED characteristics between teprotumumab-treated smokers (N=32, mean age 51 years, 75% female) and non-smokers (N=116), mean age 49.5 years, 68% female were similar. No significant differences were seen in proptosis (78.1% vs 83.6%, P=.585), diplopia (55.6% vs 70.2%, P=.175), CAS (73.3% vs 59.3%, P=.145), Overall (73.3% vs 76.1%, P=.814) responses and GO-QOL least squares mean (LSM) change (17.3 vs 17.0, P=.927) between smokers and non-smokers. The magnitude of LSM proptosis mm change was similar (-2.82 vs -3.23 mm, P=.19). Conclusion: In this post-hoc assessment, proptosis response rates with teprotumumab were comparable in smokers and non-smokers at Week 24. Teprotumumab produced clinically relevant decreases in proptosis, CAS, Overall response, diplopia, and improvements in quality of life over the study period of 24 weeks in both groups. These improvements were comparable to those seen in the overall teprotumumab-treated patient populations with TED. Smoking is a known risk factor for more severe TED but does not significantly affect response to teprotumumab. Public Presentation: 6/2/2024

Longitudinal structural changes in central serous chorioretinopathy: A multimodal imaging-based study.

To analyse the longitudinal changes in imaging parameters in eyes with acute or chronic central serous chorioretinopathy (CSCR). This was a multicentric, retrospective, longitudinal, observational study in patients with a diagnosis of CSCR and having at least 4 years of follow-up. Trend in choroidal thickness (CT), area of double layer sign (DLS), area of retinal pigment epithelium (RPE) alterations, and area of hyper-autofluorescence were analysed. A total of 175 eyes of 146 patients with a mean age of 52.9 ± 12.5 years were included. Fifty-two eyes had acute and 123 had chronic CSCR at baseline. There was an overall decreasing trend of CT values during follow up (from 354.4 ± 74.8 at baseline to 343.2 ± 109.4 at final visit). There was a steady rise in DLS width and RPE alteration in the overall cohort (from 811.7 ± 760.6 microns and 3.5 ± 3.3 disc areas respectively at baseline to 1209.1 ± 1113.18 microns, 4.1 ± 3.6 disc areas at final visit). An initial rise in hyper-autofluorescent area followed by steady fall was seen in chronic CSCR. A significant positive correlation (r = 0.54, p = 0.004) was seen between change in DLS width and change in area of hyper-autofluorescence. On linear regression analysis, lower CMT and absence of intraretinal fluid at baseline were associated with greater increase in RPE abnormalities. Acute and chronic CSCR had different pattern of change in imaging parameters with area of RPE alterations in acute CSCR not reaching values close to that of chronic CSCR eyes even after long follow up.

Outcomes After Switching to Faricimab for Refractive Macular Edema in Treatment-Experienced Eyes with Neovascular Age-Related Macular Degeneration.

To examine response to faricimab in neovascular age-related macular degeneration (nARMD) refractory to traditional anti-vascular endothelial growth factor (anti-VEGF) agents. Retrospective chart review was conducted on eyes with nARMD with persistent subretinal and/or intraretinal fluid despite previously receiving ≥15 injections with ≥2 different anti-VEGF agents. Best corrected visual acuity (BCVA) and optical coherence tomography (OCT) parameters were collected at baseline, initial post-injection visit, and most recent visit with OCT following last faricimab. Nineteen eyes were included. Average logMAR BCVA was 0.47 ± 0.60 at baseline, 0.42 ± 0.47 at initial follow-up (p=0.38), and 0.51 ± 0.63 at final visit (p = 0.50). Average central subfield thickness (CST) was 310 ± 92μm at baseline, 279 ± 88μm at initial follow-up (p = 0.001), and 274 ± 100μm at last visit (p < 0.001). 9 eyes (47%) achieved resolution of fluid at both initial and final follow-up visits. Faricimab mildly decreased CST and reduced fluid in some nARMD eyes refractory to traditional anti-VEGF agents but had minimal effect on BCVA.