Retinal Sensitivity Research Articles

The STArgardt Remofuscin Treatment Trial (STARTT): design and baseline characteristics of enrolled Stargardt patients

Background: This report describes the study design and baseline characteristics of patients with Stargardt disease (STGD1) enrolled in the STArgardt Remofuscin Treatment Trial (STARTT). Methods: In total, 87 patients with genetically confirmed STGD1 were randomized in a double-masked, placebo-controlled proof of concept trial to evaluate the safety and efficacy of 20 milligram oral remofuscin for 24 months. The primary outcome measure is change in mean quantitative autofluorescence value of an 8-segment ring centred on the fovea (qAF8). Secondary efficacy variables are best corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), mesopic microperimetry (mMP), spectral domain optical coherence tomography (SD-OCT), reading speed on Radner reading charts, and patient-reported visual function as assessed by the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) and Functional Reading Independence (FRI) Index. Results: Mean age of participants was 35±11 years with 49 (56%) female. Median qAF8 value was 438 Units (range 210-729). Median BCVA and LLVA in decimal units were 0.50 (range 0.13-0.80) and 0.20 (range 0.06-0.63), respectively. The median of the mean retinal sensitivity with mMP was 20.4 dB (range 0.0-28.8). SD-OCT showed median central subfield retinal thickness of 142 µm (range 72-265) and median macular volume of 1.65 mm3 (range 1.13-2.19). Compared to persons without vision impairment, both reading performance and patient-reported visual function were significantly lower (p<0.001, one sample t-test). Mean reading speed was 108±39 words/minute with logRAD-score of 0.45±0.28. Mean VFQ-25 composite score was 72±13. Mean FRI Index score 2.8±0.6. Conclusions: This trial design may serve as reference for future clinical trials as it explores the utility of qAF8 as primary outcome measure. The baseline data represent the largest, multi-national, STGD1 cohort to date that underwent standardized qAF imaging, reading speed assessment and vision-related quality of life measures which all contribute to the characterization of STGD1. EudraCT registration: 2018-001496-20 (09/05/2019)

Progression Rate of Visual Function and Affecting Factors at Different Stages of Retinitis Pigmentosa.

We reviewed medical records of 121 patients/235 eyes of typical retinitis pigmentosa (RP) patients who could be followed up for at least 5 years with the aim of investigating the long-term course of visual function progression at each RP stage and appropriate assessment methods. Patients were classified into three groups: mild RP (baseline mean deviation (MD) ≥ −5), moderate RP (−25 < baseline MD < −5), and late RP (baseline MD ≤ −25). Linear mixed-effect models were used to follow MD, the average retinal sensitivity of the central four points of the Humphrey field analyzer 10-2 program (S4), and visual acuity (VA) with increasing time. The associations among factors (baseline MD group, sex, hereditary form) and the interaction between each factor and time were also investigated. The mean reduction of the MD, S4, and VA for all patients was -0.37 dB/year, -0.25 dB/year, and 0.018/year, respectively. The moderate RP group had a faster progression than other groups in MD (-0.43 dB/year, p < 0.05). The moderate (-0.31 dB/year, p = 0.01) and late RP groups (-0.25 dB/year, p < 0.01) had faster progression than the mild RP group in S4. The late RP group had faster progression in VA than the other groups (0.03/year, p < 0.05). Females had a slower progression of the S4 (-0.15 dB/year, p = 0.02) and VA (0.01/year, p < 0.001) than males. The autosomal dominant group had a slower progression than the sporadic group in MD (-0.22 dB/year, p = 0.02); the autosomal dominant and autosomal recessive groups had a slower VA decline than the sporadic group (0.01/year, p = 0.03; 0.01/year, p = 0.04). Because the progression rates of VA and visual field test differed as per the RP stage, S4 and VA can also be useful assessment methods depending on the stage. Inheritance form and sex may affect the progression rate.

Odontogenic Optic Neuropathy, Clinic, Treatment Dynamics: A Case Report

Optic nerve neuropathy due to dental lesions is rare but causes complex persistent functional disorders that are difficult to diagnose. The aim of this case report is to show odontogenic optic neuropathy through treatment tactics and observation of structural dynamics and functional changes of the optic nerve with the help of a clinical case. The consultation of the patient was done as per the Department of Ophthalmology, Ivano-Frankivsk National University, Ukraine. Tests such as computed perimetry, Optically Coherent Tomography (OCT) of the optic nerve, Magnetic Resonance Imaging (MRI) of the brain, Computed Tomography (CT) of the paranasal sinuses and immunological blood tests were performed. The patient gave informed consent to access personal data and use it for scientific purposes. In the case of patient S., the combination of neuritis with lesions of the anterior part of the vascular tract is attributed to the background of multiple caries and prolapse of the teeth of the upper jaw in the sinus. Treatment includes a regimen by a dentist for caries and pulse therapy with corticosteroids. From the result, it was possible to reduce the swelling in the nerve fibers of the right eye by 35% and the left eye by 19%. The average sensitivity threshold in the right eye increased by 79% and in the left eye by 90%. In conclusion, we confirm that odontogenic optic neuropathy is a rare form of optic nerve damage. Two-stage treatment (dental and corticosteroids) reduces the nerve fibers swelling and increases retinal ganglion cells sensitivity.

Deletion of the Pedf gene leads to inflammation, photoreceptor loss and vascular disturbances in the retina

Retinal diseases are often accompanied by inflammation, vascular abnormalities, and neurodegeneration that decrease vision. Treatment with exogenous PEDF is widely shown to alleviate these conditions leading us to hypothesize that loss of function of the PEDF gene disrupts these pathways and leads to visual loss.Measurements were carried out by detailed phenotyping of PEDF null mice to assess expression of immunomodulators, glia activation, systemic inflammation, vascular disturbances, and visual sensitivity often associated with retinal pathologies.With a deletion of the Pedf gene, there was increased expression of several immune modulators in Pedf−/− retinas and serum with IL-2 and GM-CSF upregulated in both. Increases in retina glia activation and macrophage infiltration, levels of serum c-reactive protein (CRP), numbers of white and red blood cells and platelets and decreased blood glucose levels were all features associated with PEDF null mice. With PEDF gene deletion, there was also a notable increase in apoptosis in early developing retinas (PN3), reduced thickness of the photoreceptor layer, swelling of the inner plexiform layer, reduced retinal sensitivity and steady-state reduced activation of Erk and Akt, two signaling pathways used by PEDF.There is a substantial body of animal data emphasizing utility of PEDF treatment in homeostatic regulation of retinal diseases, including diabetic retinopathy and age-related macular degeneration but there is little agreement or evidence on the role of endogenous PEDF in retinal diseases. Our findings strongly support the concept that a deletion of the PEDF gene makes the retina vulnerable to diseases, and argue that endogenous PEDF plays a critical role in limiting pathological events in the retina.

Structural and functional retinal changes in patients with type 2 diabetes without diabetic retinopathy

Objective The characteristics of the early changes in preclinical diabetic retinopathy (DR) are poorly known. This study aimed to analyse the changes in the structure and function of the fundus in diabetic patients without diabetic retinopathy (NDR). Methods This prospective study enrolled patients with type 2 diabetes and healthy controls from April to December 2020. Retinal sensitivity was measured by microperimetry. The peripapillary retinal nerve fibre layer (p-RNFL) thickness, macular retinal thickness, and retinal volume were measured by optical coherence tomography (OCT). The vessel density (VD) and perfusion density (PD) of the peripapillary area, as well as the foveal avascular zone (FAZ) area, FAZ perimeter, and FAZ circularity, were measured by optical coherence tomographic angiography (OCTA). Results A total of 71 cases (100 eyes) were enrolled in the study, including 34 cases (51 eyes) in the NDR group and 37 cases (49 eyes) in the control group. The mean retinal sensitivity was lower in the NDR group than in the control group for all sectors (all p < .001). Compared with controls, the NDR group showed thinner p-RNFL in the T sector (76.24 ± 14.29 vs. 85.47 ± 19.66 µm, p = .035). The NDR group had a thinner retina in the N2 sector (304.55 ± 16.07 vs. 312.02 ± 12.30 µm, p = .010). The PD of DCP was lower in the N2 sector in the NDR group (44.92 ± 11.77 vs. 50.27 ± 6.37%, p = .044). The VD was higher in the NDR group in RPCP-S/N/I, and the PD was higher in the RPCP-S/N (all p < .05). The frequencies of perifoveal capillary drop-out, notched or punched out borders of the superficial FAZ, and loss of smooth contour were all higher in the NDR group (all p < .05). Conclusion The structure (p-RNFL thickness, VD, and PD) and function (retinal sensitivity) display some changes in diabetic patients even if they had not been found to have DR. Key messages Decreased retinal sensitivity was observed in diabetic patients before the onset of diabetic retinopathy. Compared with the control group, we found the changes in vessel density or perfusion density in a certain area, whether in SCP, DCP, or RPCP in the NDR group. Before the onset of diabetic retinopathy, the structure and function of the retina in diabetic patients had changed.

Vitrectomy combined with lens capsule flap transplantation in the treatment of high myopia macular hole retinal detachment: study protocol for a prospective randomised controlled trial

IntroductionVitrectomy combined with internal limiting membrane (ILM) peeling, flap or tamponade is widely used in the treatment of macular diseases, such as macular hole (MH) and high myopia macular hole...

Morphological and functional involvement of the inner retina in retinitis pigmentosa.

To investigate the morphological retinal parameters associated with retinal sensitivity status in retinitis pigmentosa (RP) through a quantitative multimodal imaging approach. The study was designed as an observational, prospective case series, including RP patients and healthy controls. Multimodal imaging included fundus autofluorescence (FAF), structural optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry (MP). The follow-up lasted 12 months. For each imaging modality, we performed an overall quantitative analysis and a detailed investigation based on the ETDRS-9 sectors grid. Quantitative parameters included the thickness of each retinal and choroidal layer, vessel density (VD), choriocapillaris porosity (CCP), FAF intensity and MP retinal sensitivity. We included 40 eyes (40 patients) affected by RP and 40 healthy eyes (40 controls). Mean baseline BCVA was 0.14 ± 0.18 LogMAR, with 0.18 ± 0.24 LogMAR after 1-year of follow-up. RP eyes showed statistically significant alterations of retinal and choroidal layers on the ETDRS-9 sectors grid, significant reduction of VD values and MP retinal sensitivity, and significantly higher CCP than controls. The inner retinal layers proved closely associated with the functional integrity of the posterior pole. In addition, our ROC analysis provided quantitative cutoffs connected significantly with a high probability of observing a partial sparing of MP retinal sensitivity. The inner retinal layers are closely associated with the functional integrity of the posterior pole in RP. FAF intensity reduction may be interpreted as lipofuscin metabolism impairment inducing increased phototoxic distress for retinal structures. Vascular involvement contributes to the morpho-functional deterioration of the macular region in RP.

Evaluation of Retinal Morphology and Contrast Sensitivity Function in Patients with Restless Legs Syndrome

Evaluation of Retinal Morphology and Contrast Sensitivity Function in Patients with Restless Legs Syndrome

Choroidal blood flow and visual function in idiopathic macular hole

Objective: To investigate the choroidal blood flow and visual function in idiopathic macular hole. Methods: In this prospective study, fundus structure and visual function in 22 eyes with macular hole and their fellow eyes and 16 normal eyes were assessed. The best corrected visual acuity and retinal sensitivity were detected by the EDTRS visual chart and MP1. The choroidal blood flow was observed by optical coherence tomography angiography. The choriocapillary blood flow density was measured using MatLab. The thickness of the choroid and the aperture size of macular hole were measured using enhanced depth imaging mode of Heidelberg optical coherence tomography. Results: The best corrected visual acuity and retinal sensitivity of macular hole eyes [1.02±0.20 and (13.03±2.91) dB] were significantly lower than fellow eyes [0.15±0.11, t=17.019, P<0.001 and (17.25±2.03) dB, t=-4.085, P<0.001] and normal eyes [0.04±0.05, t=21.736, P=0.001 and (16.63±2.89) dB, t=-3.134, P=0.004]. The blood flow area of choroidal capillaries in macular hole eyes [(1.33±0.29) mm2] was significantly lower than fellow eyes [(1.98±0.13) mm2; t=-9.424, P<0.001] and normal eyes [(1.93±0.12) mm2; t=-8.707, P<0.001]. The paracentral blood vessel density of the choroid capillary layer in macular hole eyes (48.91%±10.12%) was significantly lower than fellow eyes (58.27%±6.18%; t=-3.502, P=0.001) and normal eyes (55.20%±2.12%; t=-2.830, P=0.020). The subfoveal choroidal thickness of macular hole eyes [(188±21) μm] was significantly lower than fellow eyes [(217±36) μm; t=-3.672, P=0.002] and normal eyes [(229±25) μm; t=-3.304, P<0.001]. The basic diameter of macular hole eyes was correlated with the blood vessel density (r=-0.584, P=0.004), the subfoveal choroidal thickness (r=-0.511, P=0.015) and the retinal sensitivity (r=-0.432, P=0.044). The retinal sensitivity was correlated with the blood vessel density (r=0.450, P=0.035) and the subfoveal choroidal thickness (r=0.429, P=0.046). Conclusions: The retinal sensitivity and fundus blood perfusion of idiopathic macular hole was decreased, and the thickness of paracentral choroid in the contralateral eye tended to become thinner. The reduced visual function in eyes with macular hole may be associated with the decreased choroidal thickness and worse blood flow of fundus microcirculation.

Valores de normalidad de sensibilidad retiniana y fijación foveal mediante microperimetría fotópica y escotópica en población sana

PurposeTo determine normal values of fotopic and scotopic retinal sensitivity and foveal fixation obtained by microperimetry, using MP3-S microperimeter (Nidek, Gamagori, Japan), in a healthy population. MethodsObservational, cros-sectional, single centre study. Fotopic and scotopic microperimetry (MP) was performed using with a customized 13-point fovea-centered pattern in healthy volunteers without ocular pathology. A intraclass correlation coefficient was performed to evaluate fotopic and scotopic MP reliability. ResultsWe analyzed 102 eyes of 54 healthy volunteers (mean age 49.8±15 years old). The fotopic and scotopic mean retinal sensitivity (MRS) was 28.87±3.3dB and 15.72±1.9dB (95% CI 15.35-16.09), respectively, showing a significant statistical difference (P<.05). No differences were found when comparing MRS by gender group. However, when analyzing the MRS by age groups, statistically significant differences were found in both modalities of the test, MRS being higher in the group of subjects under 35 years of age, with 30.3±1.7dB in the photopic and 16.3±1.3dB in the scotopic, and lower in the group of older than 65 years, with 26.7±2.2dB in the photopic and 13.8±1.8dB in the scotopic, with P=.0001. The reliability analysis of both tests revealed an excellent reliability of the fotopic MP with a Cronbach alpha of 0.958 and a good reliability of 0.841 in scotopic MP. ConclusionMP is a test with good reliability both under photopic and scotopic conditions. MRS and fixation stability under photopic and scotopic conditions do not differ according to sex, but it does decrease with age. There is a positive correlation between photopic and scotopic MRS.

Predicting retinal sensitivity using optical coherence tomography parameters in central serous chorioretinopathy.

To predict changes in retinal sensitivity using optical coherence tomography (OCT) in eyes with central serous chorioretinopathy (CSC). Twenty-three eyes in 23 patients with CSC were enrolled. Retinal sensitivity was measured twice using microperimetry in all the examined eyes. Spectral domain OCT measurements were simultaneously conducted. The relationship between retinal sensitivity and the thicknesses of (i) the retinal nerve fiber layer plus the ganglion cell layer (RNFL + GCL), (ii) the inner nuclear layer (INL), (iii) the outer nuclear layer (ONL), and (iv) the serous retinal detachment height (SRDH) were investigated in a point-wise manner. The associations between the change in retinal sensitivity and the OCT parameters at baseline were also investigated. The mean age of the participants was 49.8 ± 10.7years. The mean SRDH was significantly lower (p < 0.001), and the mean retinal sensitivity (p < 0.001) was significantly higher at the second examination, compared with the first; however, the logMAR visual acuity (VA) did not differ significantly between the two examinations (p = 0.063). The logMAR VA was associated with retinal sensitivity at both the first and second examinations (p < 0.001). The retinal sensitivity at the second examination was significantly correlated with the retinal sensitivity, RNFL + GCL, INL, ONL, and SRDH at the first examination and with the improvement in SRDH. Retinal sensitivity was associated with the retinal structure in eyes with CSC; these parameters could be useful for predicting the change in visual function prior to treatment.

Efficacy of subthreshold micropulse laser for chronic central serous chorioretinopathy: A meta-analysis

PurposeTo evaluate the efficacy of subthreshold micropulse laser (SML) treatment for chronic central serous chorioretinopathy (CSC). MethodsPubMed, Cochrane Library, and Embase were comprehensively searched for studies published up to April 19, 2021. Randomized controlled trials (RCTs), retrospective and prospective cohort studies that compared SML with any other intervention for chronic CSC were selected. The primary outcomes were best corrected visual acuity (BCVA) and central macular thickness (CMT). Meta-analysis was performed using Review Manager 5.3. Random-effect model was used for pooled analysis. ResultsEleven studies including 834 eyes were included, with 428 eyes undergoing SML treatment and 406 eyes receiving other interventions. Pooled results showed no significant differences between SML and control with respect to BCVA, CMT, or complete resolution of subretinal fluid, while SML treatment was inferior to control in terms of subfoveal choroidal thickness (SFCT) reduction [weighted mean difference (WMD)=44.75, 95% Cl, 14.31–75.20, P<0.05, I2=72%]. However, SML was not superior to photodynamic therapy with respect to SFCT (WMD=61.29, 95% Cl, 29.50–93.08, P<0.05, I2=56%), retinal sensitivity (WMD=-1.85, 95% Cl, -3.05–-0.65, P<0.01, I2=0) or NEI-VFQ25 score (WMD=-2.44, 95% Cl, -4.72–-0.16, P<0.05, I2=0). No serious side effects of SML treatment were observed. ConclusionAvailable evidence suggests that the clinical efficacy of SML therapy is similar to other treatment modalities for chronic CSC. However, because of the lack of serious side effects, SML may be the most promising alternative therapy for chronic CSC. The study protocol was registered on PROSPERO (CRD42021 258837).

Navigated laser and aflibercept versus aflibercept monotherapy in treatment-naïve branch retinal vein occlusion: A 12-month randomized trial.

Angiostatic agents have proven effective in the treatment of macular oedema in patients with branch retinal vein occlusion (BRVO). However, treatment is inconvenient and expensive, and novel treatment regimens are warranted. We aimed to evaluate if combination treatment of navigated central retinal laser and aflibercept lowered the treatment burden in these patients. Treatment-naïve patients with BRVO and macular oedema were included at two centres and randomized 1:1 to three monthly injections of 2.0 mg aflibercept with (Group A) or without (Group B) navigated central laser, followed by aflibercept as needed from month 4 through 12. Re-treatment need was evaluated, and secondary endpoints included functional and anatomical outcomes and safety evaluated by retinal microperimetry. We evaluated 41 eyes of 41 patients with a mean age of 69.6 years. Baseline median best-corrected visual acuity (BCVA) was 70.0 letters, and median central retinal thickness (CRT) was 502 μm with no difference between Groups A (n = 21) and B (n = 20). Percentage of patients needing re-treatment after month three was 71% and 80% (p = 0.72). At month 12, groups did not differ in number of injections after loading (1 versus 2, p = 0.43), change in BCVA (+12.8 versus +15.1 letters, p = 0.48), CRT (-195 versus -181 μm, p = 0.82), or retinal sensitivity (+3.3 versus +4.1 dB, p = 0.67). In treatment-naïve BRVO patients, addition of navigated central laser to aflibercept did not lower treatment burden or affect functional or anatomical outcomes. A low number of intravitreal injections were needed for successful outcome in both treatment arms.

Visual function during and after an acute central serous chorioretinopathy episode.

To evaluate visual function parameters during and after an acute central serous chorioretinopathy (CSC) episode. A prospective study included 19 fovea involving acute CSC patients with episode resolution within 3months from the episode onset. Optical coherence tomography, best corrected visual acuity (BCVA), contrast sensitivity (CS), microperimetry (MP), and multifocal electroretinography (mfERG) were performed at baseline, 3 and 6months from the episode onset. In a sub analysis, patients were divided into groups with greater (gMV, N = 9) and lower (lMV, N = 10) macular volume at presentation, and functional outcomes were observed. BCVA (p < 0.001), average CS (CS-A) (p < 0.001), average retinal sensitivity (MP-A) (p < 0.001), mfERG amplitude densities in the first and second ring (mfERG-A1, p < 0.001; mfERG-A2, p = 0.017), and implicit times in the first, second, and third ring (mfERG-IT1, p = 0.024; mfERG-IT2, p = 0.002; mfERG-IT3, p = 0.018) improved with episode resolution 3months after the episode onset. From 3 to 6months after the episode onset, only CS-A (p = 0.045) continued to improve. Patients in thegMV group had lower mfERG-A1 (p = 0.017) and central retinal sensitivity (MP-C, p = 0.05) 6months from the episode onset. Although all functional parameters mostly improve with CSC episode resolution, only CS continues to improve thereafter. Patients with greater MV at presentation have worse functional outcomes. Visual function impairment in acute CSC patients is confined to the topographical area of subretinal fluid detachment.

Long-term follow-up of retinal morphology and physiology after 2000 mg sildenafil overdose as a means of attempted suicide: a case report

BackgroundFew case reports have described sildenafil overdose, particularly ingestion of > 1000 mg, and overdose-induced changes in visual function remain unclear. We report retinal morphology, retinal sensitivity, and findings of electrophysiological evaluation over long-term follow-up in a case of sildenafil overdose (2000 mg).Case presentationOur patient developed visual abnormalities in the paracentral visual field accompanied by photophobia, decreased contrast sensitivity, and difficulty distinguishing colors in both eyes, 8 hours after the sildenafil overdose. These symptoms did not improve throughout the course, and although abnormalities of retinal morphology and sensitivity, as well as the electroretinogram findings showed slight improvement, the patient did not recover completely at 6-month follow-up.ConclusionsWe observed that high-dose sildenafil ingestion leads to retinal toxicity; the ocular abnormalities may persist for at least 6 months. Optical coherence tomography, Humphrey perimetry, microperimetry, and multifocal electroretinography are useful to quantitatively monitor temporal changes.

Longitudinal Change in Retinal Nerve Fiber Layer Thickness and Its Association With Central Retinal Sensitivity After Epiretinal Membrane Surgery.

To investigate the longitudinal changes in the peripapillary retinal nerve fiber layer (pRNFL) thickness after epiretinal membrane (ERM) vitrectomy with internal limiting membrane (ILM) peeling, examine associations between pRNFL thickness and central retinal sensitivity, and identify predictors of postoperative pRNFL thickness. Prospective, observational, cohort study. This study enrolled 82 eyes of 82 Japanese patients that underwent surgery for unilateral idiopathic ERM, with their fellow eyes as controls. pRNFL thickness was measured in 4 (superior, temporal, inferior, and nasal) quadrants preoperatively and at 1, 3, 6, and 12 months postoperatively. Microperimetry was performed at 12 months postoperatively to evaluate central retinal sensitivity. Regression tree analysis was performed to predict pRNFL thickness at 12 months postoperatively. The temporal quadrant showed continuous pRNFL thinning after surgery, reaching statistical significance at 3, 6, and 12 months postoperatively (all P < 0.001). The pRNFL thicknesses in the fellow eyes significantly increased at all postoperative time points (all P < 0.001). At 12 months postoperatively, the average central retinal sensitivity was significantly correlated with the temporal pRNFL thickness in the eyes with ERM (r = 0.372, P < 0.001); no significant correlation was found in the fellow eyes. Regression tree analysis showed that the preoperative pRNFL thickness in the temporal quadrant and patient age were the main determinants of the temporal pRNFL thickness at 12 months postoperatively. The risk of deterioration of central retinal sensitivity after ERM vitrectomy with internal limiting membrane peeling should be considered for patients with thin temporal pRNFLs and older adults.

Intravitreal antisense oligonucleotide sepofarsen in Leber congenital amaurosis type 10: a phase 1b/2 trial

CEP290-associated Leber congenital amaurosis type 10 (LCA10) is a retinal disease resulting in childhood blindness. Sepofarsen is an RNA antisense oligonucleotide targeting the c.2991+1655A>G variant in the CEP290 gene to treat LCA10. In this open-label, phase 1b/2 (NCT03140969), 12-month, multicenter, multiple-dose, dose-escalation trial, six adult patients and five pediatric patients received ≤4 doses of intravitreal sepofarsen into the worse-seeing eye. The primary objective was to evaluate sepofarsen safety and tolerability via the frequency and severity of ocular adverse events (AEs); secondary objectives were to evaluate pharmacokinetics and efficacy via changes in functional outcomes. Six patients received sepofarsen 160 µg/80 µg, and five patients received sepofarsen 320 µg/160 µg. Ten of 11 (90.9%) patients developed ocular AEs in the treated eye (5/6 with 160 µg/80 µg; 5/5 with 320 µg/160 µg) versus one of 11 (9.1%) in the untreated eye; most were mild in severity and dose dependent. Eight patients developed cataracts, of which six (75.0%) were categorized as serious (2/3 with 160 µg/80 µg; 4/5 with 320 µg/160 µg), as lens replacement was required. As the 160-µg/80-µg group showed a better benefit–risk profile, higher doses were discontinued or not initiated. Statistically significant improvements in visual acuity and retinal sensitivity were reported (post hoc analysis). The manageable safety profile and improvements reported in this trial support the continuation of sepofarsen development.

Long-Term Continuous Assessment of Internal Limiting Membrane Filling Induced Super-Large Macular Hole Healing

To assess the long-term continuous anatomical and functional healing process of a super-large full-thickness macular hole (FTMH) after internal limiting membrane (ILM) filling and air tamponade. Prospective, interventional case series. Pars plana vitrectomy with ILM filling and air tamponade was performed in eyes with idiopathic super-large FTMH (> 900µm). Patients were divided into 3 groups according to the macular hole (MH) diameter: group A, < 1000µm; group B, 1000 to 1100µm; and group C, > 1100µm. The MH closure pattern was analyzed using optical coherence tomography. The preoperative and postoperative macular hole sensitivity, parafoveal sensitivity, and fixation status were assessed using a Microperimeter-3. The preoperative and postoperative best corrected visual acuity were measured. A monthly follow-up was conducted for 15 months postoperatively. Ninety-seven eyes from 96 consecutive patients with super-large FTMH were included in the study. Primary closure was seen in 93 of 97 eyes (95.88%), in which 88 of 97 eyes (90.72%) had a closed MH 1 week after surgery. The MH closure pattern continuously improved and significantly differed in the 3 groups (P < .05). Significant improvements in best corrected visual acuity (P < .01), parafoveal sensitivity (P < .05), and fixation stability (P < .01) were observed in all groups. Super-large FTMH (> 900µm) closed promptly within 1 week postoperatively after ILM filling and air tamponade. The morphological and functional improvement lasted over an extended period postoperatively. No central scotoma enlargement was found regardless of the closure patterns, and there was significant retinal sensitivity and fixation status improvement.

Влияние эндотампонады на функциональный результат после витрэктомии по поводу регматогенной отслойки сетчатки

Purpose. To compare the morphological and functional outcome after vitrectomy with gas and silicone oil tamponade due to rhegmatogenous retinal detachment. Material and methods. The study included 59 eyes after vitrectomy with silicone oil and gas tamponade. The 1st group (31 eyes) consisted of cases with silicone oil 1300 cSt tamponade, the 2nd group (28 eyes) – cases with C2F6 gas tamponade. Results. According to OCT data, in patients of the 1st group an epiretinal membrane occurs 4.1 times more often than in patients of the 2nd group (χ²= 4.391, df= 1,p= 0.036), cystic edema of the outer nuclear layer and the layer of Henle fibers was detected only in the 1st group in 16 % of cases (χ²= 4.766, df= 1, p = 0.029), pseudocysts and cysts of INL predominated in the 1st group (χ²= 4.325, df= 1, p=0.029). Fundus microperimetry revealed a lower value of retinal sensitivity in the group with silicone oil tamponade. In zone I it was 20 [13.0; 22.0] and 21 [20; 23] for the 1st and 2nd groups respectively (U = 183.500, p = 0.025). In zone II, a decrease was found in the upper temporal 21 [15.2; 24.5] and 23.5 [21.5; 24] (U = 176.000, p = 0.018), upper nasal 20 [16; 22.5] and 23.5 [ 20.5; 24.5] (U = 138.000, p = 0.002) and lower nasal sector 22.0 [19.0; 23.0] and 23.0 [20.5; 24] (U = 189.000, p = 0.034) for the 1st and 2nd groups respectively. In zone III, the decrease is demonstrated in the upper temporal and upper nasal quadrants, amounting to 23 [20.5; 24] and 24 [23; 25.5] (U =184.5, p =0.027); 22 [16.75; 23] and 23.5 [22.5; 25] (U =184.5, p =0.004) for the 1st and 2nd groups respectively. In zone IV, changes were detected in the nasal sectors, amounting to 21.5 [17.5; 23] and 23.5 [22; 25] (U =137.500, p = 0.002) in the upper nasal sector, 21.5 [19; 23,0] and 23 [21.5; 24.0] (U = 183.000, p = 0.025) in the lower nasal sector for the 1st and 2nd groups, respectively. Conclusion. The use of silicone oil tamponade is associated with lower retinal sensitivity compared to gas tamponade. Keywords: rhegmatogenous retinal detachment, microperimetry, silicone oil endotamponade.

Роль нутрицевтика «Ресвега форте» в комплексном лечении хориоидальной неоваскуляризации, обусловленной патологической миопией, на фоне антиангиогенной терапии ранибизумабом

Purpose. Evaluation of clinical efficacy of nutraceutical «Resvega forte» in complex treatment of myopic choroidal neovascularization (CNV) against the background of antiangiogenic therapy with ranibizumab. Material and methods. 25 patients with CNV that developed against the background of pathological myopia. In patients of the main group (16 people), a single ranibizumab 0.5 mg intravitreal injection was supplemented the appointment of two courses of the “Resvega forte” complex, 1 capsule 2 times a day continuously for 3 months and then second course after 6 months at the same dosage. Patients of the comparison group (9 people) were not prescribed the “Resvega forte” complex. For objective diagnostic, the best corrected visual acuity (BCVA), retinal electric sensitivity threshold (EST) and electric lability (EL) of optic nerve, data of optical coherence tomography (OCT) and OCT-angiography (OCT-A) of the retina were evaluated. Study monitoring was performed within 12 months from the start of treatment. Indications for repeated ranibizumab intravitreal injections were persistence of CNV activity or its recurrence. Results. By the end of observation period (12 months), BCVA in patients of the main group was 0.57 ± 0.04, and in the comparison group – 0.21 ± 0.03. In patients of the main group, retinal EST decreased to 62.5 ± 1.5µA, and EL of optic nerve increased to 35.4 ± 1.3 Hz, while in the comparison group decrease in EST and increase in EL were less significant. The total number of intravitreal injections during 12 months of observation in patients of the main group was 2–3, while in the comparison group it was 5–6. Conclusion. At comparable morphometric characteristics of remission of pathological process without signs of activity of choroidal neovascular membrane by 12 months of observation in the main group, against the background of use “Resvega forte”, compared to the comparison group, increase in visual acuity by 3.5 times and increase number of patients with improved electrophysiological parameters by 1.3 times, were achieved. Keywords: pathological myopia, myopic choroidal neovascularization, ranibizumab, “Resvega forte”.