Could internal limiting membrane peeling before Voretigen neparvovec-ryzl subretinal injection prevent focal chorioretinal atrophy?

Purpose: To report the effect of internal limiting membrane (ILM) peeling prior to Voretigen Neparvovec-ryzl (VN) subretinal injection on focal chorioretinal atrophy development in patients presenting with RPE65-mediated Leber congenital amaurosis (LCA). Design: Retrospective case series. Methods: Three patients who underwent bilateral subretinal VN injection for RPE65-mediated LCA were followed up for 18-24 months. ILM peeling was performed unilaterally in patients 1 and 2 and bilaterally in patient 3. Chorioretinal atrophy was identified on fundus biomicroscopy, non-mydriatic retinography and/or ultrawide field fundus imaging. Best corrected visual acuity (BCVA), spectral-domain optical coherence tomography (SD-OCT), visual fields, full-field stimulus threshold (FST) and visual functioning questionnaire score (NEI-VFQ-25) were reported. Outcome measures were changes in BCVA, visual fields, FST, NEI-VFQ-25, and chorioretinal atrophy location. Results: Chorioretinal atrophy at the injection site exclusively developed in eyes which did not undergo prior ILM peeling. In patient 3, bilateral pre-operative nummular chorioretinal alterations progressed toward epithelial atrophic patches in the mid and extreme retinal periphery 18 months after VN injection. BCVA and visual fields improved bilaterally. NEI_VFQ 25 remained stable in patient 1 and improved in patient 2 and 3. FST test improved bilaterally in patient 3. Conclusions: ILM peeling prior to VN injection seems to be a smoother and safer technique to administer VN treatment and may prevent secondary focal atrophy development at the injection site. However, another type of more extended chorioretinal atrophy might exist and could be related to LCA evolution or to incompletely understood adverse effect of VN product.

Retinal microvascular changes in unilateral functional amblyopia detected by oct-angiography and follow-up during treatment.

OBJECTIVE: To evaluate the macular microvascular changes using optical coherence tomographic angiography (OCT-A) in children with unilateral amblyopia and their reversibility during treatment. METHODS: Patients with unilateral strabismic or anisometropic amblyopia or residual amblyopia from early congenital cataract surgery, examined between October 2019 and March 2021, were included. Vessel density and perfusion density in the superficial capillary plexus and area, perimeter and circularity of the foveal avascular zone (FAZ) were analysed using OCT-A in amblyopic eyes, contralateral eyes and control group healthy eyes. Correlation analyses between the microvascular parameters and the visual acuity were performed. In a pilot study on a few patients from the amblyopic cohort, longitudinal follow-up during treatment was also performed. RESULTS: A total of 128 eyes of 64 patients were included: 32 amblyopic eyes compared with 32 contralateral eyes and 64 control eyes. Vessel density and perfusion density in the superficial capillary plexus were significantly lower in amblyopic eyes compared to control eyes in 6 × 6 mm (p < 0.02) and 3 × 3 mm (p < 0.01) scans. Correlation analyses showed a linear decrease in vessel density and perfusion density with decreasing visual acuity. The microvascular changes observed were reversible with the occlusion treatment of amblyopia (p < 0.001). CONCLUSIONS: The study found a decrease in vessel density and perfusion density in the macula of children with unilateral functional amblyopia. These microvascular changes were correlated with visual acuity and appeared to be reversible with treatment of amblyopia. On the whole, OCT-A appears to be a relevant complementary examination when it comes to diagnosing and monitoring functional amblyopia.

Telangiectatic capillaries causing persistent diabetic macular edema successfully treated by photodynamic therapy.

PURPOSE: To report two cases of persistent macular edema caused by the exudation of diabetic telangiectatic capillaries (TelCaps) which have been successfully treated with photodynamic therapy (PDT). METHODS: review of data from two patients suffering from persistent macular edema caused by parafoveolar TelCaps. In both cases, conventional laser was impossible, because TelCaps were to close from foveal center. RESULTS: The use of focal PDT on perifoveolar TelCaps permitted to reduce persistent macular edema and to avoid inefficient intra-vitreal anti-vascular epithelial growth factor (anti-VEGF) or steroid injections. In both cases, visual acuity was fully restored four to six months after PDT. Central Macular Thickness was also normalized in the first case and significantly reduced in the second case. In both cases, visual gain was sustained throughout the whole follow-up period (2 and 1 year respectively). CONCLUSION: PDT can be helpful to treat diabetic macular edema caused by TelCaps non-responding to approved intravitreal therapy or for which conventional laser is contraindicated.

Single-Masked Randomized Phase 2 Study Assessing 2 Forms of Hypofractionated Proton Therapy in Patients With Large Choroidal Melanomas.

PURPOSE: Patients with large uveal melanomas are at major risk of liver metastases. Some patients are reluctant to undergo the standard treatment (ie, immediate enucleation). Proton therapy yields 5-year local control rates and eyeball retention of >85% and ≈20% in large uveal melanomas. Patients with T3/T4 uveal melanomas refusing enucleation were randomized between standard 4 to 13 Gy-fraction or moderately hypofractionated 8 to 6.5 Gy-fraction proton therapy. The main endpoint was the 2-year local recurrence-free survival without enucleation. METHODS AND MATERIALS: A single-masked 1:2 randomized phase 2 trial was conducted between 2015 and 2017 with planned endoresection and distance to the posterior pole as strata. Local events were defined as local relapse, or enucleation due to complications or relapse. RESULTS: The 32 patients, with a mean age of 64 years, had T3/4 (N = 17/15), M1 (N = 2) uveal melanomas, of mean tumor diameter and thickness of 16.5 mm and 9.1 mm, and of posterior location in 56.5%. Median follow-up was 56.7 months. The 2-year local recurrence-free survival rate without enucleation was 79% (95% confidence interval, 65%-96%), similar in both arms. There were 9 enucleations, 3 at relapse and 6 for toxicities. Twelve patients had distant metastases. The 2-year-overall survival was 72% (95% confidence interval, 58%-89%). At baseline, visual acuity by average logarithm value of the minimum angle of resolution was 0.68 and 0.70 in the standard and experimental arms, and at last follow-up 2 and 1.7, with mean differences of 1.44 and 1.01, respectively (P = .39). CONCLUSION: An 8-times 6.5 Gy scheme is feasible without deteriorating local control and with similar toxicity rates in patients with large uveal melanomas. Larger studies incorporating adjuvant treatments are warranted.

Binocular visual function improvement after pars plana vitrectomy for epiretinal membrane.

PURPOSE: To report binocular visual function changes after pars plana vitrectomy for epiretinal membrane (ERM) and the related outcomes. METHODS: Twenty-three eyes of 23 patients operated on for ERM were included in a retrospective study. Clinical data, best-corrected visual acuity (BCVA), contrast sensitivity and binocular visual function were assessed pre- and 1 and 3 months post-operatively. Binocular visual function assessment included the evaluation of fusional amplitudes (i.e., vergences) by the synoptophore, far distance stereopsis using polarized glasses and near stereopsis using Randot and TNO tests. Central macular thickness (CMT) was measured on Spectral Domain - Optical Coherence Tomography. RESULTS: Mean age of the patients was 67 years. Mean BCVA and contrast sensitivity significantly improved post-operatively at one (p = 0.0006 and p = 0.0022, respectively) and 3 months (p < 0.0001 and p < 0.0001, respectively), while CMT significantly decreased after 1-3 months (p < 0.0001 and p < 0.0001, respectively). Fusional amplitudes improved after 3 months (p < 0.0001). Far distance and near stereopsis significantly improved after 3 months (p < 0.0001 and p = 0.0007 for Randot test, and p < 0.0001 for TNO test, respectively). CONCLUSIONS: Pars plana vitrectomy for ERM surgery leads to an improvement of monocular and binocular visual functions (i.e., binocular fusion, near and far distance stereopsis), within 3 months post-operatively.

Multiple metrics assessment method for a reliable evaluation of corneal suturing skills.

This study aimed to evaluate the efficiency of a multiple metrics assessment method to differentiate between surgeons of differing experience while performing a corneal suturing task. Volunteer ophthalmologists were assigned to three groups (senior [SG], junior [JG] and novice [NG]) according to their experience in corneal suturing. All participants performed three sessions of corneal wound closure by three stitches. Suturing and participant posture were recorded with cameras, and assessed by two blind assessors for stitch quality (using Zhang score) and ergonomics (using Rapid Upper Limb Assessment [RULA] score). Task duration was recorded. Objective analyses of stitches geometry and instrument position were carried out. We included 24 participants: 5 in the SG, 8 in the JG and 11 in the NG. Stitch quality was significantly better and time to perform the procedure significantly lower in more experienced groups (p < 0.001 and p = 0.002, respectively). SG participants better respected regular distance and parallelism between stitches compared to others (p = 0.01). Instrument position was similar between groups, although SG participants minimized their back-and-forth movements compared to NG participants. Ergonomics assessment was similar. Multiple metrics assessment efficiently determined how to differentiate between novices and experienced surgeons on corneal suturing skills, providing hints for future training studies.

Optical Coherence Tomography Angiography in Diabetic Macular Edema Treated with Intravitreal Aflibercept: A 48-Week Observational Study (the DOCTA Study).

INTRODUCTION: Central vision loss due to diabetic macular edema (DME) is related to the macular edema itself but also, in some cases, to alterations of the foveal avascular zone (FAZ). The aim of this trial was to study changes in macular vessels in eyes with DME treated with aflibercept using optical coherence tomography angiography (OCTA). METHODS: This was a longitudinal, prospective, noncontrolled, single-arm study. The primary objective was the quantitative assessment of macular vessels over time in patients with DME treated with intravitreal aflibercept during a 48-week follow-up using OCTA. RESULTS: Twenty-six DME eyes from 26 patients were included (mean age, 64.6 years; women, 53.8%; prior anti-VEGF treatment, 46.1%). Each eye received a mean (SD) of 7.2 (2.2) injections. The following parameters of the FAZ did not change during the 48-week follow-up: the mean (SD) FAZ area varied from 0.19 (0.19) mm2 at baseline (n = 22) to 0.23 (0.20) mm2 at week 48 (n = 15), boundary from 1.54 (1.21) to 2.04 (1.20) mm, and circularity from 0.45 (0.33)% to 0.57 (0.20)%. There was no change in perfusion density and vessel density of the macula in the 3-mm circle. As expected, mean central retinal thickness, macular volume, and visual acuity improved during follow-up. CONCLUSION: No change in macular perfusion was observed in eyes with DME during a 48-week follow-up after intravitreal injections of aflibercept. Randomized controlled trials using OCT angiography in large populations with extended observation periods are needed to assess changes in macular vessels after intravitreal anti-VEGF treatment.

The effect of strabismus surgery on the learning abilities of school-aged children.

PURPOSE: To evaluate whether strabismus surgery improves the learning performance - calculation, reading and drawing - of school-aged children. METHODS: In a case-control study, patients between the ages of 7 and 10 years with horizontal strabismus, recommended for surgical correction, were prospectively included. Reading, calculating and drawing abilities were evaluated before and 3 months after corrective strabismus surgery using standardized tests. Cases were compared to control patients: patients with a surgical indication postponed due to the COVID lockdown. RESULTS: Forty-two operated patients and 42 controls between the ages of 7 and 10 years with horizontal strabismus were included. The average reading speed was 65.8 words per minute pre-operatively compared to 80.6 words per minute post-operatively (p = 0.0038). The average drawing score was 71.1 pre-operatively compared to 84.3 post-operatively (p = 0.012). The average calculation score was 3.2 pre-operatively compared to 3.4 post-operatively (p = 0.363). Improvement given by strabismus surgery was confirmed avoiding the learning effect by comparison with the control group. The improvements observed were more significant in the youngest patients and esotropia. CONCLUSIONS: This study highlights that strabismus surgery significantly improved the children's reading fluency and drawing task execution. These encouraging data should be taken into account when considering the indications for strabismus surgery.

LONG-TERM MICROVASCULAR REMODELING AND CYSTIC CHANGES AFTER RETINAL DETACHMENT TREATED WITH SILICON OIL TAMPONADE.

PURPOSE: To determine the long-term microvascular alterations associated with macular cystic changes after retinal detachment surgery with silicone oil tamponade. METHODS: The results of two optical coherence tomography angiographies performed at 11 months and 38 months after silicone removal were retrospectively analyzed for 30 eyes. The data were compared between both measurements and between eyes with macular cysts (MC+) and without macular cysts (MC-). Two patterns of cysts were identified and compared: cysts exclusively involving the inner nuclear layer (INLc) and cysts present in all retinal layers. RESULTS: At both end points, 20 eyes (67%) presented with macular cysts, 12 of them (40%) had INLc. At the first end point, vascular density of superficial capillary plexus was higher and superficial foveal avascular zone was smaller in MC+ eyes than in MC- eyes (P = 0.04 and P = 0.017, respectively). At the second end point, vascular density of superficial capillary plexus significantly decreased in MC+ eyes as compared with the first end point (P < 0.001) and superficial foveal avascular zone enlarged (P < 0.001). Macular central thickness decreased between follow-ups only in eyes with INLc (P < 0.01). The final best-corrected visual acuity was better in eyes with INLc than in eyes with cysts present in all retinal layers (P < 0.01). There was no difference between the final best-corrected visual acuity in eyes with INLc and MC- eyes. CONCLUSION: Macular cysts are a common finding long after silicon removal. Vascular remodeling seems characterized by an initial increase of the vascular density of superficial capillary plexus in eyes with cysts, which is followed by its progressive decrease. The INLc is the most common pattern of cysts. They are associated with a progressive decrease of the central macular thickness without visual impairment.

Efficacy and Safety of 0.1% Cyclosporine versus 2% Cyclosporine in the Treatment of Severe Vernal Keratoconjunctivitis in Children.

Introduction: Vernal keratoconjunctivitis (VKC) is an inflammatory condition in children that can cause severe eye complications. Treatment is based on corticosteroid therapy during flare-ups, then antihistamines and cyclosporine in calmer periods. The dosage and posology of cyclosporine are subject to debate. Methods: The aim of the study is to compare the evolution in symptomatic and clinical scores, and need for topical corticosteroid treatment in a population of children with severe VKC treated with two dosages of cyclosporine treatment (0.1% and 2%). Data were compiled on inclusion then every three months from March, with a total follow-up duration of 12 months. Data concerning patient evolutions and complications were collected for the two treatment groups. Results: The mean age of the 46 children was 8.8 ±2.4 years with age at onset of symptoms of 5.1 ± 0.9 years. The cohort was predominantly (65%) male. Corticosteroid dependence on inclusion was present in 52% of the children included. A significant improvement in the various symptomatic and clinical scores was observed following treatment with cyclosporine (0.1% and 2%). Use of topical corticosteroid treatment reduced from 19 drops per month on inclusion to 4 drops per month at 12 months. Safety was comparable for the two groups. Conclusion: Treatments with cyclosporine 0.1% and 2% lead to a favourable evolution in clinical and symptomatic scores and reduced corticosteroid use. Cyclosporine 0.1% is an interesting alternative to the 2% dosage, particularly due to its availability and ease of handling.

Most nonpathological eyes present a small area of hyperreflective Henle's fiber layer on pupil-centered optical coherence tomography.

PURPOSE: Henle's fiber layer (HFL) is hyporeflective and indistinct on pupil-centered optical coherence tomography (OCT). However, a small area of HFL is also found to be hyperreflective on pupil-centered OCT. This study characterized the hyperreflective HFL of healthy eyes on pupil-centered OCT and investigated the possible physiological and functional relationship of hyperreflective HFL. METHODS: Subjects with different degrees of ametropia underwent a complete ophthalmologic examination, including binocular function by synoptophore and Titmus test, ocular axial length, refractions, and pupil-centered OCT angiography coupled with OCT. The area of hyperreflective HFL was manually plotted and calculated using the Optovue AngioVue system technology. The possible ocular physiological and functional relationship with the area of hyperreflective HFL was investigated. RESULTS: A total of 111 subjects (222 eyes) without other ocular diseases were enrolled, of which 164 eyes (74%) presented hyperreflective HFL. The average area of hyperreflective HFL was 0.71 ± 0.07 mm2. The area of hyperreflective HFL was significantly related to spherical diopters (P = 0.032). The average binocular area of hyperreflective HFL was 1.38 ± 0.17 mm2. The binocular area of hyperreflective HFL was significantly related to the angle of superposition and far stereoacuity (P = 0.013 and 0.038, respectively). CONCLUSION: Most healthy eyes present a small area of hyperreflective HFL, which might be due to alternation of the orientation of some Henle fibers by ametropia during the development of visual function postpartum. The small area of hyperreflective HFL may serve as a marker in identifying the boundary of HFL on OCT.

OCT-Angiography for Detection of Choroidal Neovascularization: A Retrospective Real-Life Study.

PURPOSE: The purpose of the study was to assess OCT-angiography (OCT-A) contribution for choroidal neovascularization (CNV) detection, with respect to multimodal imaging (MMI) modality (including OCT, fluorescein angiography (FFA), and indocyanine green angiography [ICG]), in a real-life consultation practice. METHODS: Data of all consecutive patients undergoing OCT-A examination for CNV suspicion were collected between September 2017 and September 2019 at Strasbourg University Hospital, France. Only eyes which had anti-VEGF injection in the last 3 months were excluded. All types of neovascularization were included. For all patients, data from OCT, OCT-A, FFA, and ICG were interpreted by residents and retinal specialists, independently. Final diagnosis of CNV was based on decision to treat. Sensibility, specificity, and predictive values were computed for OCT-A alone and for MMI (OCT combined to angiography). They were computed for each group. OCT-A was also assessed as "contributory" (i.e., assessing without doubt the presence or absence of CNV) or not, with respect to MMI. RESULTS: In total, 161 eyes of 145 patients were included. MMI sensibility was better than OCT-A sensibility (93.8 vs. 65.6%). OCT-A specificity was better than MMI specificity (96.9 vs. 89.5%). OCT-A was essential for diagnosis in 16.9% of cases. Sensibility and specificity values for all exams were better when interpreted by retinal specialists than residents. OCT-A was judged "contributory" in 57.4% of eyes. OCT-A was significantly less contributory when artefacts were present (32.9% of eyes with artefacts vs. 63.5% without, p < 0.001). CONCLUSION: OCT-A showed to be essential in diagnosing CNV in >16% of cases. However, it often failed to conclude for the absence of CNV, which obliged to perform more exams such as angiography. OCT-A must be part of diagnostic procedure for CNV detection but does not discard angiography in everyday life practice.

Choroidal thickness and vessel pattern in myopic eyes with dome-shaped macula.

AIM: To analyse the choroidal thickness (CT) and vessel pattern of myopic patients with dome-shaped macula (DSM) and their association with the DSM axis and serous retinal detachment (SRD). METHODS: Retrospective study. The CT and vessel pattern were assessed on optical coherence tomography (OCT), OCT-angiography and ultra-wide-field photography. RESULTS: 27 eyes of 18 subjects (mean age: 65 years) were included. Compared with the 11 eyes (41%) with horizontal DSM, the 16 eyes (59%) with vertical DSM had a shorter axial length (25.8±2 mm vs 28.3±2.5 mm; p=0.01), a higher mean macular bulge height (624.4±207 µm vs 255.4±160.3 µm; p=0.0001) and a thicker CT (183.1±91.1 µm vs 72±38.3 µm; p<0.001). Large choroidal vessels crossed the macular area in 75% of eyes with vertical DSM vs 27% of eyes with horizontal DSM (p=0.02), whereas a watershed zone framing the macula was more often seen in horizontal DSM (72% vs 25%, p=0.02). Thirteen eyes (48%) had an SRD that was not associated with the DSM axis, the mean bulge height, the CT or the vessel pattern. CONCLUSION: The presence of an SRD did not correlate with the DSM axis, the CT or the vessel pattern. However, the rate of large choroidal vessels crossing the macula was higher in vertical DSM than in horizontal DSM.

State of the Art in Robot-Assisted Eye Surgery.

Despite the advantages that robot-assisted surgery can offer to patient care, its use in ophthalmic surgery has not yet progressed to the extent seen in other fields. As such, its use remains limited to research environments, both basic and clinical. The technical specifications for such ophthalmic surgical robots are highly challenging, but rapid progress has been made in recent years, and recent developments in this field ensure that the use of this technology in operating theatres will soon be a real possibility. Fully automated ocular microsurgery, carried out by a robot under the supervision of a surgeon, is likely to become our new reality. This review discusses the use of robot-assisted ophthalmic surgery, the recent progress in the field, and the necessary future developments which must occur before its use in operating theatres becomes routine.

Functional and anatomical outcomes after successful repair of macula-off retinal detachment: a 12-month follow-up of the DOREFA study.

PURPOSE: To report visual and anatomical outcomes and determine predictors of good visual acuity (VA) recovery after macula-off rhegmatogenous retinal detachment (RD). METHODS: Prospective multicentre study including 115 eyes from 115 patients successfully operated on for RD, with assessment of VA and spectral-domain optical coherence tomography (SD-OCT) macular images at 1, 3, 6 and 12 months after surgery. RESULTS: Over the follow-up period, VA significantly improved from median [IQR] 62 [46; 72] ETDRS letters at 1 month to 75 [67; 80] ETDRS letters at 12 months (p < 0.001) with a concomitant decreased number of eyes with any SD-OCT lesions (p < 0.001). The presence of subretinal fluid (SRF) significantly decreased (p < 0.001), as did the number of photoreceptor (PR) layer lesions (p = 0.04). At 12 months, lesions in the PR layer and poor VA recovery were significantly associated with a longer time to surgery (p = 0.007 and p < 0.001, respectively). The rate of patients without PR lesions increased from 40.9% at 1 month to 60.0% at 6 months and 73.9% at 12 months (p < 0.001). The incidence of epiretinal membrane (ERM) significantly increased (p < 0.001), while cystoid macular oedema (CME) remained stable over time. Visual acuity (VA) at 3 months postoperatively was a good reflection of final VA recovery (p < 0.001). CONCLUSION: Visual acuity (VA) improved in parallel with the decreasing number of eyes with SD-OCT lesions after macula-off rhegmatogenous RD. A long time to surgery was the only preoperative factor associated with poor VA recovery after retinal detachment surgery.

Panton-Valentine Leucocidin of Staphylococcus aureus Induces Oxidative Stress and Neurotransmitter Imbalance in a Retinal Explant Model.

Purpose: Endophthalmitis models have reported the virulent role of Panton-Valentine leucocidin (PVL) secreted by Staphylococcus aureus on the retina. PVL targets retinal ganglion cells (RGCs), expressing PVL membrane receptor C5aR. Interactions between PVL and retinal cells lead to glial activation, retinal inflammation, and apoptosis. In this study, we explored oxidative stress and retinal neurotransmitters in a rabbit retinal explant model incubated with PVL. Methods: Reactive oxygen species (ROS) production in RGCs has been assessed with fluorescent probes and immunohistochemistry. Nuclear magnetic resonance (NMR) spectroscopy quantified retinal concentrations of antioxidant molecules and neurotransmitters, and concentrations of neurotransmitters released in the culture medium. Quantifying the expression of some pro-inflammatory and anti-inflammatory factors was performed using RT-qPCR. Results: PVL induced a mitochondrial ROS production in RGCs after four hours' incubation with the toxin. Enzymatic sources of ROS, involving nicotinamide adenine dinucleotide phosphate-oxidase and xanthine oxidase, were also activated after four hours in PVL-treated retinal explants. Retinal antioxidants defenses, that is, glutathione, ascorbate and taurine, decreased after two hours' incubation with PVL. Glutamate retinal concentrations and glutamate release in the culture medium remained unaltered in PVL-treated retinas. GABA, glycine, and acetylcholine (Ach) retinal concentrations decreased after PVL treatment. Glycine release in the culture medium decreased, whereas Ach release increased after PVL treatment. Expression of proinflammatory and anti-inflammatory cytokines remained unchanged in PVL-treated explants. Conclusions: PVL activates oxidative pathways and alters neurotransmitter retinal concentrations and release, supporting the hypothesis that PVL could induce a neurogenic inflammation in the retina.

Improved performance and safety from Argus II retinal prosthesis post-approval study in France.

PURPOSE: To evaluate the post-approval long-term outcomes of the Argus II Retinal Prosthesis, with a specific focus on its functional visual benefit in patients' daily activities. METHODS: Eighteen patients with bare light perception due to end-stage retinitis pigmentosa were included in a French prospective, multicentre, single-arm study and followed for 2 years. Visual benefit in patients' daily activities was monitored through the use of the Functional Low-vision Observer Rated Assessment (FLORA), and the final score at 2 years was the primary effectiveness outcome. Standardized visual assessments were also performed. Device- or procedure-related adverse events were recorded. RESULTS: Seventeen subjects completed the study. Positive impacts of the Argus II system on functional vision and well-being were demonstrated for over 70% of subjects on the FLORA. Among the daily activities/tasks tested, finding doorways was one of the most statistically significantly improved tasks (p < 0.001), along with estimating the size of an obstacle (p < 0.001), visually locating a place setting on a dining table (p < 0.001) and visually locating people in a non-crowded setting (p < 0.001). Visual function was improved on most standardized tests. Only two device- or procedure-related serious adverse events were observed (one vitreous haemorrhage and one endophthalmitis, both resolved with treatment). No explantation was required. CONCLUSION: This first report of a completed post-approval study of Argus II with a two-year follow-up demonstrates the safety and effectiveness of the Argus II System in a real-world cohort of patients and further highlights its real functional benefit in implanted patients' daily activities.