Eye Institute 25-Item Visual Function Research Articles

Diabetic Retinopathy and Quality of Life

The association between diabetic retinopathy (DR) and quality of life (QoL) has not been thoroughly investigated. To investigate the association between DR and both vision-related QoL (VRQoL) and general health-related QoL (HRQoL). MEDLINE, EBSCO, Embase, and Web of Science were searched from their inception to April 2022. Studies included adults with DR and a measure of QoL. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Two assumption-free meta-analyses were conducted. Analysis 1 included studies with participants without DR as the referent group to which QoL scores of participants with DR, grouped according to DR severity, were compared. Analysis 2 included all studies with participants with DR and a measure of QoL. QoL scores were pooled within categories of DR severity, and comparisons were made between these categories. QoL measured using HRQoL and VRQoL scales. A total of 93 articles were included: 79 in the meta-analyses and 14 in the narrative results. VRQoL was recorded in 54 studies, HRQoL in 26, and both in 13 studies. The most commonly used scales were the National Eye Institute 25-item Visual Function Questionnaire (VFQ-25) (n = 49) for VRQoL and the Short Form (SF) Health Survey (n = 18) for HRQoL. Thirty-five studies reported VFQ-25 composite scores. Analysis 1 consisted of 8 studies including 1138 participants with DR and 347 participants without DR. Compared with participants without DR, the composite VFQ-25 score was 3.8 (95% CI, 1.0-6.7) points lower in those with non-vision-threatening DR (NVTDR), 12.5 (95% CI, 8.5-16.5) lower in those with any DR, and 25.1 (95% CI, 22.8-27.2) lower in VTDR (P < .001 for trend). Analysis 2 consisted of 35 studies including 6351 participants with DR. The pooled mean VFQ-25 composite score was 91.8 (95% CI, 91.0-92.7) for participants with NVTDR, 77.6 (95% CI, 76.9-78.3) for any DR, and 73.2 (95% CI, 72.6-73.7) for VTDR (P < .001 for trend). HRQoL scores had weak or no associations with NVTDR and strong associations with VTDR. This study found that VRQoL declined with the presence and severity of DR. Interventions to reduce progression of DR at both early and more advanced stages could improve VRQoL.

Comparing Half-Dose Photodynamic Therapy with Subthreshold Micropulse Laser for the Treatment of Central Serous Chorioretinopathy

To compare the anatomic and functional outcomes of half-dose photodynamic therapy (PDT) and yellow 577-nm subthreshold micropulse laser (SMLT) in treating patients with chronic central serous chorioretinopathy (CSCR). Prospective, double-masked, randomized, controlled clinical trial. Patients with chronic CSCR confirmed by clinical features and multimodal imaging. Eligible patients were randomized (1:1) to receive half-dose PDT or SMLT. The same treatment was repeated if persistent subretinal fluid (SRF) was observed. Treatment responses were evaluated 1 month after treatment and every 3 months until the end point at 12 months. The primary outcome measure was the complete resolution of SRF on OCT scan at month 12. Secondary outcomes included the changes in best-corrected visual acuity (BCVA), central macular thickness (CMT) as measured by OCT, retinal sensitivity as measured by microperimetry, and vision-related quality of life using the National Eye Institute 25-Item Visual Function Questionnaire. Between April 2017 and October 2020, 68 patients were recruited. At 1 month after treatment, SRF resolved in 8 (24.2%) of 33 patients receiving SMLT and in 20 (58.8%) of 34 patients receiving half-dose PDT. This increased to 23 (82.1%) of 28 patients in the SMLT group and 30 (90.9%) of 33 patients in the half-dose PDT group at 12 months of follow-up. Kaplan-Meier survival curves showed significantly faster resolution of SRF in the half-dose PDT group than the SMLT group (P= 0.016). Both groups showed significant improvement in BCVA (-0.12 ± 0.21, P= 0.005 for SMLT;-0.13 ± 0.12, P < 0.001 for half-dose PDT), CMT (-154.2 ± 105.6, P < 0.001 for SMLT;-140.8 ± 94.0, P < 0.001 for half-dose PDT), and retinal sensitivity (5.70 ± 5.02, P < 0.001 for SMLT; 6.05 ± 3.83, P < 0.001 for half-dose PDT) at 12 months compared with baseline. There was no significant difference between the 2 treatment groups at each time point in all investigations except BCVA at 3 months (P= 0.03). When comparing half-dose PDT to subthreshold SMLT, this study has shown both treatments to be viable options, with half-dose PDT achieving faster anatomic success and functional improvement. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Corticosteroid implants for chronic non-infectious uveitis.

Corticosteroid implants for chronic non-infectious uveitis.

Visual Functioning and Mortality of Age-Related Macular Degeneration Patients in a Colorado Cohort

To investigate the relationship between visual functioning as measured by the National Eye Institute 25-Item Visual Function Questionnaire (VFQ-25) and mortality in patients with various stages of age-related macular degeneration (AMD). Observational cohort study. Patients with AMD enrolled in the University of Colorado AMD Registry between July 9, 2014 and December 31, 2021 were included. Age-related macular degeneration cases were classified into early AMD, intermediate AMD, geographic atrophy, neovascular AMD, or both advanced types of AMD (neovasuclar and geographic atrophy both present) using multimodal imaging and the Beckman and Classification of Atrophy Meetings criteria. Visual Function Questionnaire-25 composite and subscale scores at the time of study enrollment were calculated. Cox proportional hazards modeling was used to assess time to event for mortality utilizing univariate and multivariable models, which adjusted for all variables significantly associated with mortality. The measures of association were hazard ratios (HRs) and 95% confidence intervals (CIs). All-cause mortality statistics were obtained through a collaborative agreement with the Colorado Department of Public Health and Environment. Death rates through October 19, 2022 were compared by demographics and potential confounders. Analysis was completed on a cohort of 876 patients, of which 180 (20.6%) died during the follow-up period. Average follow-up time for this cohort was 52.5 (standard deviation: 26.6) months. In univariate analysis, composite VFQ-25 score and all subscale scores aside from ocular pain were significantly associated with time to mortality. Additionally, age, AMD category, marital status, history of smoking, and multiple chronic comorbid conditions were significantly associated with time to mortality. In multivariable analysis, for each 10-point increase in a patient's VFQ-25 scores for general health and driving, the risk of death decreased with HR of 0.85 (95% CI: 0.80, 0.91; P < 0.0001) and 0.92 (95% CI: 0.87, 0.97; P= 0.005), respectively. Composite and other subscale scores were not significantly associated with mortality after adjusting for confounding variables. This cohort of AMD patients had a 20% rate of death in the 52.5-month average follow-up time. Better general health and ability to drive, as measured by the VFQ-25, were each separately associated with significantly lower risk of death among individuals with AMD. The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents, and Age-Related Macular Degeneration Study: A Randomized Controlled Trial for Submacular Hemorrhage Secondary to Age-Related Macular Degeneration

To compare the efficacy and the safety of submacular hemorrhage (SMH) management with either surgical pars plana vitrectomy (PPV) or pneumatic displacement (PD), with tissue plasminogen activator (TPA) and vascular endothelial growth factor (VEGF) inhibitor added to each arm. Randomized, open-label, multicenter superiority study. Ninety patients with neovascular age-related macular degeneration (nAMD) aged ≥50 years, with recent SMH (≤14 days) greater than 2 optic disk areas and predominantly overlying the retinal pigment epithelium. Patients were randomly assigned to surgery (PPV, subretinal TPA [max 0.5 ml/50 μg], and 20% sulfahexafluoride [SF6] tamponade) or PD (0.05 ml intravitreal TPA [50 μg] and 0.3 ml intravitreal pure SF6). Both groups were asked to maintain a head upright position with the face forward at 45° for 3 days after intervention and received 0.5 mg intravitreal ranibizumab at the end of the intervention, at Month 1 and 2, as the loading phase, and then on a pro re nata regimen during a 6-month follow-up. The primary efficacy endpoint was mean best-corrected visual acuity (VA) change at Month 3. The secondary endpoints were mean VA change at Month 6, National Eye Institute 25-item Visual Function Questionnaire (VFQ-25) composite score value at Month 3 and 6, number of anti-VEGF injections, and complications during the 6-month follow-up. Of the 90 patients randomized, 78 (86.7%) completed the 3-month efficacy endpoint visit. The mean±SD age was 83.3±8.2 years, and 66.3% were female. The mean duration of symptoms before treatment was 7.5±4.4 days. The mean VA change from baseline to Month 3 in the surgery group (+16.8 letters, [95% CI, 8.7; 24.9]) was not significantly superior to the PD group (+16.4 letters, [95% CI, 7.1;25.7]; adjusted difference β, -1.9 [95% CI, -14.9;11.0], P = 0.767). Both groups achieved similar secondary outcomes at Month 6. No unexpected ocular safety concerns were observed in either group. Surgery did not yield superior visual gain nor additional benefit for SMH secondary to nAMD compared to PD at 3 months, with intravitreal anti-VEGF added to each arm. Both treatment strategies lead to a clinical improvement of visual acuity without safety concerns for SMH over 6 months. Both design and results of the trial cannot be used to establish equivalence between treatments.

Efficacy of Modified Endoscopic Dacryocystorhinostomy in the Treatment of Chronic Dacryocystitis

Background: Untreated chronic dacryocystitis (CD) can lead to serious ocular complications. Objectives: This study aimed to analyze the efficacy of modified endoscopic dacryocystorhinostomy (DCR) in the treatment of CD and the effects on ocular surface, inflammatory response, and immune function of patients. Methods: A retrospective cohort study was conducted to examine the clinical data of 110 patients (110 eyes) with CD who visited The First People's Hospital of Wenling, China, from July 2018 to February 2021, and they were divided into a conventional group (62 patients and 62 eyes underwent conventional DCR) and modified group (48 patients and 48 eyes received modified endoscopic DCR). The perioperative indexes, efficacy, and complications of the two groups were compared, and the changes in ocular surface, inflammatory response, and immune function of the patients before and 3 months after the surgery were observed. Results: The intraoperative bleeding, hospitalization cost, and 12-h postoperative visual analogue scale (VAS) score were lower, while the operative time and hospitalization time were shorter in modified group than in the conventional group (P&lt;0.05). The total treatment efficacy was higher (91.67%) in the modified group than in the conventional group (72.58%), and the recurrence rate was lower in the modified group (4.17%) than in the conventional group [16.13%, P&lt;0.05]. The ocular surface symptom scores, Schirmer I test, tear break-up time, degree of tear overflow scores were lower in the modified group than in the conventional group at 3 months postoperatively (P&lt;0.05); soluble interleukin-1β, interleukin-6, high-sensitivity C-reactive protein, CD8+ levels were lower, and CD3+, CD4+, CD4+/CD8+ levels were higher in the modified group than in the conventional group at 3 months postoperatively (P&lt;0.05). At 3 months postoperatively, the scores of activity impairment, general health, and visual status on the National Eye Institute 25-Item Visual Function Questionnaire were higher in the modified group than those in the conventional group (P&lt;0.05). The overall complication rate in the modified group (8.33%) was not different from that in the conventional group [14.52%, P&gt;0.05]. Conclusion: Modified DCR has the advantages of short operation time, less trauma, less pain and fewer complications, and is conducive to improving ocular surface function, reducing inflammatory response, and improving immune function and quality of life of patients.

Corticosteroid implants for chronic non-infectious uveitis.

Corticosteroid implants for chronic non-infectious uveitis.

The intraocular implant and visual rehabilitation improve the quality of life of elderly patients with geographic atrophy secondary to age-related macular degeneration

IntroductionThe objective of this prospective study was to evaluate the effects of intraocular macular lens implantation and visual rehabilitation on the quality of life of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).MethodsPatients with bilaterally decreased near vision (not better than 0.3 logMAR with the best correction), pseudophakia, were included in the project. The Scharioth macula lens (SML) was implanted into the patients’ better-seeing eye. Intensive visual rehabilitation of the ability to perform nearby activities was performed for 20 consecutive postoperative days. All subjects were examined before and after SML implantation ophthalmologically. The National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) was administered before and 6 months after surgery.ResultsTwenty eligible patients with mean age 81 years (63 to 92 years) were included in the project: 7 males and 13 females. Nineteen of them completed the 6-month follow-up. Near uncorrected visual acuity was 1.321 ± 0.208 logMAR before SML implantation and improved to 0.547 ± 0.210 logMAR after 6 months (dz = − 2.846, p < 0.001, BF10 = 3.29E + 07). In the composite score of the NEI VFQ-25, there was an improvement in the general score and the specific domains related to the implantation. Participants reported fewer difficulties in performing near activities (dz = 0.91, p = 0.001, BF10 = 39.718) and upturns in mental health symptoms related to vision (dz = 0.62, p = .014, BF10 = 3.937).ConclusionSML implantation, followed by appropriate rehabilitation, improved near vision and increased the quality of life of visually handicapped patients with AMD in our project.

Impact of Visual Impairment on Vision-Related Quality of Life in Parkinson's Disease.

Visual impairment is frequent and highly disabling in Parkinson's disease (PD); however, few studies have comprehensively evaluated its impact on vision-related quality of life. To evaluate the relationship between visual function tests and the visual impairment perceived by PD patients in daily living activities. We cross-sectionally evaluated 62 PD patients and 33 healthy controls (HC). Visual disability was measured with a comprehensive battery of primary visual function and visual cognition tests (visual outcomes), and vision-related quality of life was evaluated with the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25). The relationship between visual outcomes and NEI VFQ-25 sub-scores was analyzed with Pearson's correlations and stepwise linear regression. In PD patients, and not in HC, most NEI VFQ-25 sub-scores were significantly correlated with Cube Analysis and Dot Counting from Visual Object and Space Perception (VOSP) battery (visual perception), Clock Drawing Test (visuoconstructive capacity) and Trail Making Test part-A (visual attention and processing speed) and to a lesser extent with high- and low-contrast visual acuity. Dot Counting (VOSP) was the test primarily associated with most NEI VFQ-25 sub-scores (5 out of 12). Roth-28 color test was the one that best explained the variance of Peripheral Vision (R2: 0.21) and Role Difficulties (R2: 0.36) sub-scores of NEI VFQ-25, while photopic contrast sensitivity explained 41% of Driving sub-score variance. Vision-related quality of life in PD is mainly influenced by alterations in visual perception, visuoconstructive capacity and visual attention and processing speed. Future studies are warranted to confirm and further extend our findings.

Comparison of clinical outcomes of astigmatic correction using toric intraocular lens

AIM: To compare the clinical effects of two brands of Toric intraocular lens used in surgical correction of cataract with corneal astigmatism. METHODS: Totally 35 patients (50 eyes) with corneal astigmatism who underwent ophthalmic surgery from April 2019 to July 2019 were retrospectively analyzed. Among them, 25 eyes of 20 patients were implanted with Rayner 623T, while 25 eyes of 15 patients with Alcon AcrySof Toric intraocular lens (IOL). Three months after surgery, the uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA), residual astigmatism, rotational degree of intraocular lens, contrast sensitivity, objective visual quality and the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) scale score were compared. Vector analysis was performed using the Alpins method. RESULTS: The mean postoperative UCDVA and BCDVA (logMAR) in the Rayner group were 0.17±0.20 and 0.08±0.15, respectively (P&gt;0.05), while those in the Alcon group were 0.21±0.16 and 0.10±0.11, respectively (P&gt;0.05). The mean residual astigmatism in the Rayner group was -0.57±0.24 D while that in the Alcon group was -0.50±0.28 D (P&gt;0.05). There was no statistically significant difference between the two groups in IOL rotational stability, vector analysis parameters, contrast sensitivity and objective visual quality (P&gt;0.05). The NEI VFQ-25 scale score was 85.16±5.91 in the Rayner group while it was 82.08±6.16 in the Alcon group (P&gt;0.05). CONCLUSION: The two brands of toric intraocular lens-Rayner 623T and Alcon AcrySof toric show no significant difference in their clinical outcomes.

Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative Age-Related macular degeneration (TIGER): study protocol for a phase 3, pan-European, two-group, non-commercial, active-control, observer-masked, superiority, randomised controlled surgical trial

BackgroundNeovascular (wet) age-related macular degeneration (AMD) can be associated with large submacular haemorrhage (SMH). The natural history of SMH is very poor, with typically marked and permanent loss of central vision in the affected eye. Practice surveys indicate varied management approaches including observation, intravitreal anti-vascular endothelial growth factor therapy, intravitreal gas to pneumatically displace SMH, intravitreal alteplase (tissue plasminogen activator, TPA) to dissolve the clot, subretinal TPA via vitrectomy, and varying combinations thereof. No large, published, randomised controlled trials have compared these management options.MethodsTIGER is a phase 3, pan-European, two-group, active-control, observer-masked, superiority, randomised controlled surgical trial. Eligible participants have large, fovea-involving SMH of no more than 15 days duration due to treatment-naïve or previously treated neovascular AMD, including idiopathic polypoidal choroidal vasculopathy and retinal angiomatous proliferation. A total of 210 participants are randomised in a 1:1 ratio to pars plana vitrectomy, off-label subretinal TPA up to 25 μg in 0.25 ml, intravitreal 20% sulfahexafluoride gas and intravitreal aflibercept, or intravitreal aflibercept monotherapy. Aflibercept 2 mg is administered to both groups monthly for 3 doses, then 2-monthly to month 12. The primary efficacy outcome is the proportion of participants with best-corrected visual acuity (BCVA) gain of ≥ 10 Early Treatment Diabetic Retinopathy (ETDRS) letters in the study eye at month 12. Secondary efficacy outcomes (at 6 and 12 months unless noted otherwise) are proportion of participants with a BCVA gain of ≥ 10 ETDRS letters at 6 months, mean ETDRS BCVA, Radner maximum reading speed, National Eye Institute 25-item Visual Function Questionnaire composite score, EQ-5D-5L with vision bolt-on score, Short Warwick and Edinburgh Mental Wellbeing score, scotoma size on Humphrey field analyser, and presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using independent reading centre multimodal image analysis (12 months only). Key safety outcomes are adverse events, serious adverse events, and important medical events, coded using the Medical Dictionary for Regulatory Activities Preferred Terms.DiscussionThe best management of SMH is unknown. TIGER aims to establish if the benefits of SMH surgery outweigh the risks, relative to aflibercept monotherapy.Trial registrationClinicalTrials.govNCT04663750; EudraCT: 2020-004917-10.

Beyond the Visual Acuity: Assessing the Visual Function in mCNV Patients After Anti-VEGF Treatment.

Purpose: To investigate visual function and vision-related quality of life (VR-QoL) changes in patients with myopic choroidal neovascularization (mCNV) after ranibizumab treatment.Methods: Quantitatively evaluate the objective tests of visual function (visual acuity, microperimetry, and metamorphopsia by m-Charts) before and after 3+prn (pro re neta) ranibizumab treatment for 1 year. The National Eye Institute 25-Item Visual Function Questionnaire (VFQ-25) was performed to evaluate the VR-QoL.Results: A total of 57 eyes of 57 patients were included in this study. The median average metamorphopsia score was 0.65 before treatment and improved to 0.45 after treatment (p = 0.0003). There was also a significant difference in the average threshold, macular integrity, and proportion of patients with stable fixation by the microperimetry (p < 0.000, p < 0.0001, and p = 0.03, respectively). After treatment, the VR-QoL composite, general vision subscale, and vision-related mental health subscale score were increased with borderline or statistical significance (p = 0.088, p = 0.0038, and p = 0.012, respectively). Subgroup analysis demonstrated parallel improvement of the VR-QoL score, metamorphopsia, average macular threshold, and fixation stability in patients with or without visual acuity increase. By multiple linear regression analysis, the VFQ-25 score after anti-VEGF treatment was only associated with the baseline VFQ-25 score and macular integrity. Improvements in the VFQ-25 score were only associated with changes in the metamorphopsia score.Conclusions: Integral lifting in several aspects of visual function was observed in mCNV after ranibizumab treatment. Macular integrity and metamorphopsia, but not visual acuity, were associated with VR-QoL.

Non-infectious uveitis burden on quality of life and work impairment assessed through different psychometric questionnaires.

The purpose of this study was to evaluate the association between a novel psychometric 12-item questionnaire (U-qest) and other validated questionnaires to assess quality of life and work impairment in patients with non-infectious uveitis. Data were collected at baseline and 3 months postbaseline using U-qest and two other validated questionnaires: The National Eye Institute 25-Item Visual Function Questionnaire (VFQ-25) and the 12-Item Short-Form Health Survey (SF-12). A total of 136 patients (52.2% female) aged 47.9 ± 14.8 years (mean ± SD) were enrolled in 14 uveitis referral centres. U-qest correlated moderately with VFQ-25 and SF-12 at baseline and at 3 months. Both U-qest and VFQ-25 scores improved as disease improved; however, U-qest also detected improvement in patients for whom VFQ-25 scores did not improve. Disease activity was shown to significantly affect activity impairment. Patients and physicians expressed positive perceptions regarding the use and benefit of this instrument. U-qest showed very good reliability in terms of internal consistency (Cronbach's alpha = 0.91). U-qest can be considered a useful tool to assess the burden of uveitis on quality of life.

PRO45 Health-Related Quality of Life in Patients with Age-Related Macular Degeneration and Their Caregivers: A Review of Evidence

Patients with age-related macular degeneration (AMD) experience blurred vision which progresses to blindness with age. This condition negatively impacts patient’s health-related quality of life (HRQoL) and also increases caregiver burden. The objective is to summarize HRQoL studies in AMD including a description of the instruments and their psychometric properties. The literature search was conducted from 2015 till January 2021 using two electronic databases—PubMed and EBSCOhost. The search strategy included all international studies that reported the use of HRQoL instruments and their psychometric properties in adult AMD population. Clinical studies, economic evaluations, reviews, and commentaries were excluded from the review. A total of seven studies were identified that assessed HRQoL in AMD. Only one study was conducted in the United States and the rest were from six different countries. Different disease classifications were utilized—wet and dry AMD (n=2) and early, intermediate, and late-stage AMD (n=3). A few studies (n=5) utilized unilateral or bilateral patients. Disease-specific and generic instruments utilized in patients and caregivers included the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFG-25), Visual Function Questionnaire (VFQ), Impact Vision Impairment Questionnaire (IVI), Macular Disease Dependent Quality of Life Questionnaire (MacDQoL), Low Luminance Deficit LLD, EuroQoL-5D (EQ-5D), Short Form-12 (SF-12), and Caregiver Reaction Assessment (CRA) scale. Majority of studies (n=5) utilized NEI VFG-25 instrument and only one study reported the psychometric properties of the HRQoL instrument (IVI). One study reported the impact of AMD on caregiver burden and two studies reported the effect of ranibizumab on HRQoL. The importance of measuring HRQoL in patients and caregivers in AMD has been reported in several countries. The assessment of physical, psychological, and emotional aspects of AMD can assist providers and policymakers in better understanding the needs and providing optimal care to both patients and caregivers.

Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial

To report the efficacy and safety of large diameter scleral lenses and determine their suitability in Asian subjects with intractable ocular surface diseases. This prospective study enrolled intractable ocular surface diseases subjects with uncorrected visual acuity > counting finger but ≥ 0.3 logMAR and best-corrected visual acuity (BCVA) ≥ 0.3 logMAR, to fit large diameter scleral lenses for 12 weeks. 21 eyes (13 subjects) consisting ten eyes (47.6%) with persistent epithelial defects, 6 (28.6%) with graft-versus-host disease, 4 (19.0%) with Stevens–Johnson syndrome and one (4.8%) with severe dry eye were ultimately enrolled. Primary outcome measures were the visual acuity, corneal and conjunctival fluorescein staining, Ocular Surface Disease Index (OSDI), and National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25). At week 12 with large diameter scleral lenses, BCVA improved from 0.77 logMAR to 0.27 logMAR (P < 0.001). High-grade corneal and conjunctival fluorescein staining proportion decreased from 61.90 to 14.29% and 52.38 to 9.52%, respectively (P = 0.0036 and 0.0063, respectively). OSDI and NEI-VFQ-25 improved from 67.89 to 34.69 and 51.40 to 64.48, respectively (P < 0.001). No adverse effects were observed. In Asians with intractable ocular surface diseases, large diameter scleral lens improves visual acuity and alleviates signs and symptoms of ocular surface diseases without any significant complications.Trial registration Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (Project No. HI12C0015 (A120018)). Clinical Trials.gov, NCT04535388. Registered 18 August 2020—Retrospectively registered, http://clinicaltrials.gov/ct2/show/NCT04535388.

Study time, glasses utilization and age affect quality of life among senior first-year Chinese myopia students.

To compare the quality of life of senior first-year students with normal vision and myopia, and to explore the risk factors related to quality of life in students with myopia. In this study, 1103 senior first-year students were enrolled in ten high schools. These students were divided according to the diopter degree, with 916 myopia students and 187 normal vision students. Visual function indexes, such as naked eye vision, were measured and recorded, and social demographic indexes and the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) was used. The differences in quality of life between the two groups were compared. Multiple linear regression analysis was used to explore the possible risk factors for quality of life in myopia students. In the NEI VFQ-25, the total quality of life scores of myopia students (77.06 ± 15.66) were lower than those of normal vision students (85.49 ± 12.37). The difference was statistically significant (p = 0.007). In the correlation analysis, the total scores of quality of life in myopia students were positively correlated with wearing glasses (p = 0.049), and were negatively correlated with study time (p = 0.029). Multiple linear regression analysis showed that study time, wearing glasses and age were risk factors affecting quality of life in myopia students. Our results show that senior first-year myopia students have lower quality of life scores than students with normal vision. Study time, wearing glasses and age are risk factors for quality of life in senior first-year myopia students.

1716. Prospective Multicenter Observational Cohort Study to Assess the Burden of Herpes Zoster Disease in the Eye: Baseline Results of Initial Patients

BackgroundHerpes Zoster Ophthalmicus (HZO) affects 10-20% of adults with herpes zoster; ≥ 50% of these cases manifest as serious ocular diseases. This 1-year prospective observational cohort study aims to determine patient-reported HZO symptoms as well as economic and quality of life burden among 300 HZO patients from 6 major US ophthalmology practices. Here, we report baseline data from 13 initial enrollees.MethodsInclusion criteria were: participants ≥ 18 years, diagnosis of clinically active HZO, English or Spanish speaking, be willing and able to respond to study assessments, not be enrolled in a concurrent interventional HZO trial. Information are collected via 1) a clinical assessment form completed by the practice (baseline) and 2) patient questionnaires (baseline, 3, 6, and 12 months) on symptoms, medications, healthcare use, vision function, depression, and work productivity impact. Baseline results are presented for patients recruited during the first 6 months of enrollment from the first 4 sites to go live: diagnoses, and patient-reported symptoms and outcomes (eight-item Patient Health Questionnaire [PHQ-8] for depressive symptoms, National Eye Institute 25-item Visual Function Questionnaire [NEI-VFQ-25] for vision-related quality of life, and Zoster Brief Pain Inventory [ZBPI] for pain).ResultsThe mean age of participants is 71 years; 11 are female and 9 are retired. Seven participants are college graduates or hold other degrees. All have health insurance coverage, with most (10) having primary insurance through Medicare. HZO diagnoses (Table 1) were: keratitis (4), iridocyclitis (4), conjunctivitis (1), other HZO diagnosis (3), other ocular diagnosis (6). Patient-reported symptoms (Table 2) were: pain above the eye, sensitivity to light, redness, feeling of sand/grit in the eye (9 each). The mean overall PHQ-8 and NEI-VFQ-25 scores were 5.9 (Standard Deviation [SD]:4.5) and 74.6 (SD:13.9), respectively; the mean ZBPI score for worst pain severity was 3.3 (SD:3.8) (Table 3).Table 1. HZO Diagnosis at Baseline based on Clinical Assessment Form (N=13) Table 2. Patient-reported Symptoms in the HZO-Affected Eye at Baseline (N=13) Table 3. Patient-reported Outcomes: Depressive Symptoms, Vision-Related Quality of Life, and Herpes Zoster Pain at Baseline (N=13) ConclusionThis study represents the first large scale effort to quantify HZO burden. Findings will inform development of a formal patient-reported symptom scale for use in research and clinical practice.FundingGlaxoSmithKline Biologicals SA (GSK study identifiers: 209235/HO-17-17967)DisclosuresLaura T. Pizzi, PharmD, MPH, ORCID: 0000-0002-7366-7661, GlaxoSmithKline (Research Grant or Support) Soham Shukla, PharmD, ORCID: 0000-0002-4139-0856, GSK (Employee)Rutgers University (Employee) Brandon J. Patterson, PharmD, PhD, GSK (Employee, Shareholder) Debora A. Rausch, MD, ORCID: 0000-0001-9759-2687, GSK (Employee) Philip O. Buck, PhD, MPH, ORCID: 0000-0002-3898-3669, GSK (Employee, Shareholder) Ann P. Murchison, MD, MPH, GSK (Grant/Research Support)

Improvement of the Quality of Life in Patients with Age-Related Macular Degeneration by Using Filters.

Background: Age-related macular degeneration (AMD) is a disease with an increasing incidence due to the general aging of the population that decreases the patient’s quality of life. This work aims to study whether selective cut optical filters improve the AMD patient’s quality of life. Methods: Prospective and longitudinal study in 79 patients. Visual acuity, contrast sensitivity, and the line differences in the Colenbrander test were measured. Patients answered The National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25), which measures the quality of life related to vision before and after using cut optical filters. Results: There was an improvement of 5.99 points (3.7–8.3) in NEI VFQ-25 after wearing filters. This improvement was 4.0 points for 450-nm filters and 12.7 points for 511-nm filters. For patients with visual acuity (VA) < 0.25, results of NEI VFQ-25 increased by 10.11 points (1.19–19.02) and for patients with late AMDs, results increased by 5.33 points (1.31–9.35). Conclusions: Selective filters improve the quality of life of patients with AMD. The success rate in the fitting of filters is better for those with VA lower than 0.25 and those with late or advanced AMD.

Anti-vascular endothelial growth factor in neovascular age-related macular degeneration \u2013 a systematic review of the impact of anti-VEGF on patient outcomes and healthcare systems

BackgroundSystematically review the evidence describing the impact of anti–vascular endothelial growth factor (anti-VEGF) therapy on neovascular age-related macular degeneration (nAMD) patient outcomes and healthcare resource utilization.MethodsA systematic literature review was completed using Medline and EMBASE for publications prior to July 2018, and proceedings from major ophthalmology conferences (January 2016 to July 2018). The search strategy combined terms for nAMD with terms for anti-VEGF and study design. The review focused on publications describing the impact of anti-VEGF on blindness, visual impairment, vision-related quality of life (VRQoL), mortality, and costs. The search targeted data collected in epidemiological or observational studies to reflect real-world outcomes but also considered modeling-based approaches.ResultsThe use of anti-VEGF in clinical practice was associated with significant reduction in the incidence of blindness by nAMD. Population-based analyses reported reduction in incidence among the general population of 47% (9.1 cases/100,000 in 2006 to 4.8 cases/100,000 in 2011). Among patients aged ≥50 years, a reduction of 50% was observed (52.2 cases/100,000 in 2000 to 25.7 cases/100,000 in 2010). In some cases, the odds of decreased vision (defined as decline from normal to moderate, moderate to severe, or severe to blindness) fell by 41% following introduction of anti-VEGF. Patients’ VRQoL improved with treatment, with patients reporting a positive impact shortly after treatment was initiated. Change on National Eye Institute 25-Item Visual Function Questionnaire score from baseline to month 12 ranged from 0.7 to 4.4. Although nAMD patients report signs of depression and anxiety, the evidence suggests that there is no association between the use of anti-VEGF and the prevalence or diagnosis of depression. The introduction of anti-VEGF led to increased overall treatment costs due to replacement of existing less frequently administered treatments (e.g. photodynamic therapy) and increased number of patients treated (prior to anti-VEGF, only ~ 20% of patients were eligible for treatment).ConclusionsThe introduction of anti-VEGF agents has been associated with a positive impact on patient-relevant outcomes, including a significant reduction in incidence of blindness and visual impairment by nAMD. Anti-VEGF agents replaced less-effective treatments, improving patient outcomes and broadening the patient population eligible for treatment.

Use of Virtual Reality Simulation to Identify Vision-Related Disability in Patients With Glaucoma

Clinical assessment of vision-related disability is hampered by the lack of instruments to assess visual performance in real-world situations. Interactive virtual reality (VR) environments displayed in a binocular stereoscopic VR headset have been designed, presumably simulating day-to-day activities to evaluate vision-related disability. To investigate the application of VR to identify vision-related disability in patients with glaucoma. In a cross-sectional study, 98 patients with glaucoma and 50 healthy individuals were consecutively recruited from a university eye clinic; all participants were Chinese. The study was conducted between August 30, 2016, and July 31, 2017; data analysis was performed from December 1, 2017, to October 30, 2018. Measurements of visual acuity, contrast sensitivity, visual field (VF), National Eye Institute 25-item Visual Function Questionnaire Rasch score, and VR disability scores determined from 5 VR simulations: supermarket shopping, stair and city navigations in daytime, and stair and city navigations in nighttime. Duration required to complete the simulation, number of items incorrectly identified, and number of collisions were measured to compute task-specific and overall VR disability scores. Vision-related disability was identified when the VR disability score was outside the normal age-adjusted 95% confidence region. Virtual reality disability score. In the 98 patients with glaucoma, mean (SD) age was 49.8 (11.6) years and 60 were men (61.2%); in the 50 healthy individuals, mean (SD) age was 48.3 (14.8) years and 16 were men (32.0%). The patients with glaucoma had different degrees of VF loss (122 eyes [62.2%] had moderate or advanced VF defects). The time required to complete the activities by patients with glaucoma vs healthy individuals was longer by 15.2 seconds (95% CI, 5.5-24.9 seconds) or 34.1% (95% CI, 12.4%-55.7%) for the shopping simulation, 72.8 seconds (95% CI, 23.0-122.6 seconds) or 33.8% (95% CI, 10.7%-56.9%) for the nighttime stair navigation, and 38.1 seconds (95% CI, 10.9-65.2 seconds) or 30.8% (95% CI, 8.8%-52.8%) for the nighttime city navigation. The mean (SD) duration was not significantly different between the glaucoma and healthy groups in daytime stair (203.7 [93.7] vs 192.9 [89.1] seconds, P = .52) and city (118.7 [41.5] vs 117.0 [52.3] seconds, P = .85) navigation. For each decibel decrease in binocular VF sensitivity, the risk of collision increased by 15% in nighttime stair (hazard ratio [HR], 1.15; 95% CI, 1.08-1.22) and city (HR, 1.15; 95% CI, 1.08-1.23) navigations. Fifty-eight patients (59.1%) with glaucoma had vision-related disability in at least 1 simulated daily task; a higher proportion of patients had vision-related disability in nighttime city (27 of 88 [30.7%]) and stair (27 of 90 [30.0%]) navigation than in daytime city (7 of 88 [8.0%]) and stair (19 of 96 [19.8%]) navigation. The overall VR disability score was associated with the National Eye Institute 25-item Visual Function Questionnaire Rasch score (R2 = 0.207). These findings suggest that vision-related disability is associated with lighting condition and task in patients with glaucoma. Virtual reality may allow eye care professionals to understand the patients' perspectives on how visual impairment imparts disability in daily living and provide a new paradigm to augment the assessment of vision-related disability.