ABSTRACT
Objective: To assess the efficacy and safety of the PRIMA neurostimulation system with a subretinal microchip for improving visual acuity (VA) in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD) at 48-months postimplantation. Design: Feasibility clinical trial of the PRIMA subretinal prosthesis in patients with atrophic AMD, measuring best-corrected ETDRS VA (Clinicaltrials.govNCT03333954). Subjects: Five patients with GA, no foveal light perception, and VA of logarithm of the minimum angle of resolution (logMAR) 1.3 to 1.7 (20/400-20/1000) in their worse-seeing "study" eye. Methods: In patients subretinally implanted with a photovoltaic neurostimulation array containing 378 pixels of 100 µm in size, the VA was measured with and without the PRIMA system using ETDRS charts at 1 m. The system's external components, augmented reality glasses, and pocket computer provide image processing capabilities, including zoom. Main Outcome Measures: Visual acuity using ETDRS charts with and without the system, as well as light sensitivity in the central visual field, measured by Octopus perimetry. Anatomical outcomes demonstrated by fundus photography and OCT up to 48 months postimplantation. Results: All 5 subjects met the primary end point of light perception elicited by the implant in the scotoma area. In 1 patient, the implant was incorrectly inserted into the choroid. One subject died 18 months postimplantation due to study-unrelated reasons. ETDRS VA results for the remaining 3 subjects are reported here. Without zoom, VA closely matched the pixel size of the implant: 1.17 ± 0.13 pixels, corresponding to a mean logMAR of 1.39, or Snellen of 20/500, ranging from 20/438 to 20/565. Using zoom at 48 months, subjects improved their VA by 32 ETDRS letters versus baseline (standard error 5.1) 95% confidence intervals (13.4, 49.9; P < 0.0001). Natural peripheral visual function in the treated eye did not decline after surgery or during the 48-month follow-up period (P = 0.08). Conclusions: Subretinal implantation of PRIMA in subjects with GA experiencing profound vision loss due to AMD is feasible and well tolerated, with no reduction of natural peripheral vision up to 48 months. Prosthetic central vision provided by photovoltaic neurostimulation enabled patients to reliably recognize letters and sequences of letters, and with zoom, it improved VA of up to 8 ETDRS lines. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
ABSTRACT
BACKGROUND/AIMS: To analyse the complications and outcomes of vitrectomy surgery for endophthalmitis. METHODS: This was a retrospective case series. All cases that underwent 23-gauge vitrectomy surgery for endophthalmitis at a tertiary centre between 1 February 2013 and 1 February 2018 were included. Main outcome measures were as follows: visual acuity (VA) at final visit and post-vitrectomy complications. RESULTS: 33 patients were included in the study with 20 men and 13 women, average age 63 years. Main post-surgical causes for endophthalmitis included phacoemulsification (n=9), trabeculectomy (n=5), intravitreal injection (n=5), corneal graft (n=4), vitreoretinal surgery (n=3) and endogenous endophthalmitis (n=6). Average follow-up was 18 months (SD 14). 21/33 (64%) patients had baseline perception of light VA. Analysis of exogenous endophthalmitis cases only demonstrated: mean LogMAR VA improved significantly from 2.68 to 1.66 (p=0.001). At final follow-up, 12% had VA of 6/12 or better, and 28% had VA of 6/36 or better. Vitrectomy within 7 days resulted in improved final VA outcomes (1.49 vs 2.16 LogMAR, p=0.032). Complications included retinal detachment (24.2%), macular hole (3%), hypotony (6%), suprachoroidal haemorrhage (3%) and enucleation/evisceration (6%). CONCLUSION: Vitrectomy for endophthalmitis leads to VA gains in some cases. Surgical outcomes may be improved with early vitrectomy performed within 7 days of the initial event for exogenous endophthalmitis. Patients should be advised of the potential risk of severe complications with/and without surgery.
