ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS: Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion.

PURPOSE: To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients. METHODS: This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing. RESULTS: Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years. CONCLUSION: Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.

Assessment of Postoperative Morphologic Retinal Changes by Optical Coherence Tomography in Recipients of an Electronic Retinal Prosthesis Implant.

Importance: The postoperative retinal changes at the interface between an implant electrode array and the retina and whether these anatomic changes have an association with the patient visual performance are unknown. Objective: To report morphologic changes in recipients of an Argus II Retinal Prosthesis. Design, Setting, and Participants: This consecutive, noncomparative case series study included a retrospective review of the preoperative and postoperative optical coherence tomography of 33 eyes among 33 individuals who underwent Argus II Retinal Prosthesis System implantation between October 28, 2011, and June 8, 2017, at 2 different centers, by the same surgeon (S.R.). Thirteen patients received an implant at Azienda Ospedaliero Universitaria Pisana, Pisa, Italy, between October 28, 2011, and October 27, 2014, and 20 patients underwent surgery at Azienda Ospedaliera Universitaria Careggi, Florence, Italy, between December 20, 2014, and June 8, 2017. Patients were excluded if they did not reach the 6-month follow-up. Main Outcomes and Measures: All patients were evaluated before surgery, during the first postoperative day, and at 1, 3, 6, 12, and 24 months (subsequently once a year, except for patient-related adverse events), with a comprehensive ophthalmic examination, retinal fundus photography, spectral-domain optical coherence tomography, and visual function tests to evaluate the stability or improvement of their visual performance. Results: Of the 20 patients included in the analysis, all were of white race/ethnicity, 12 (60%) were male, and the mean (SD) age was 57.4 (11.6) years. Optical coherence tomography revealed the development of a fibrosislike hyperreflective tissue limited at the interface between the array and retina in 10 eyes (50%). In 9 of 10 patients (90%), fibrosis evolved and progressed to retinal schisis. Despite the development of the fibrosis and schisis, there was no deterioration in the patient's visual performance evaluated prospectively with visual function tests (square localization and direction of motion). Conclusions and Relevance: Optical coherence tomography may be used to observe the retinal anatomic changes in patients with an Argus II Prothesis. This analysis revealed the development of a fibrosislike hyperreflective tissue limited at the interface between array and retina that progressed to retinal schisis but with no deterioration in the patients' visual performance.

The Argus II Retinal Prosthesis: 12-month outcomes from a single-study center.

PURPOSE: To study the anatomic and functional outcomes of Argus II Retinal Prosthesis System implantation in patients with retinitis pigmentosa. DESIGN: Interventional case series. METHODS: The study population included 6 patients with visual acuity no better than light perception. After the Argus II Retinal Prosthesis System was implanted, complications and anatomic and functional results were studied. The main outcome measures were mobility, square localization, direction of motion, grating visual acuity, and Goldmann visual field, all of which were assessed. Optical coherence tomography was performed. RESULTS: Implantation of the Argus II Retinal Prosthesis System was safely performed in all patients. One patient experienced postoperative elevation in intraocular pressure, which was controlled medically. In 1 patient, moderate detachment of the choroid occurred postoperatively, and it resolved spontaneously. One patient withdrew from the study. Wound dehiscence, endophthalmitis or retinal detachment was not observed. All patients were able to locate a bright light on the ceiling and a dark line on the floor after the surgery. Performance in square localization tests improved in 4 patients, and direction of motion improved in 3 patients. One patient achieved grating visual acuity. Goldmann visual field test results improved in all patients. CONCLUSIONS: The patients showed improvement in visual tasks after the surgery, and the device was well tolerated and functional over a 1-year follow-up period. A rigorous patient-selection process is necessary to maximize patient compliance with the rigorous follow-up testing schedule. Both patients and medical staff should be prepared for a lengthy, arduous rehabilitation process.

Optic disc pit maculopathy: the value of small-gauge vitrectomy, peeling, laser treatment, and gas tamponade.

PURPOSE: To report the outcome of 10 patients with optic pit maculopathy (OPM) and evaluate the role of small-gauge vitrectomy, gas endotamponade, and additional laser photocoagulation treatment. METHODS: We retrospectively investigated 10 patients who underwent small-gauge, sutureless vitrectomy for OPM, detachment of the posterior hyaloid, internal limiting membrane (ILM) peeling, endolaser photocoagulation on the temporal margin of the optic disc, and gas tamponade. Preoperative and postoperative best-corrected visual acuity (BCVA) was recorded and optical coherence tomography (OCT) imaging was performed. RESULTS: Seven out of 10 patients gained at least 2 lines of vision; 2 patients gained 1 line of vision. Visual improvement occurred more than 3 months after surgery. One myopic patient developed a macular hole postoperatively, resulting in a poor functional result even though complete retinal attachment was achieved. The functional outcome did not always correlate well with the OCT imaging, in which complete retinal reattachment was observed in 5 out of 10 eyes. CONCLUSIONS: The therapeutic approach should include both small-gauge vitrectomy and ILM peeling to relieve vitreoretinal traction, as well as laser photocoagulation of the temporal margin of the optic disc in order to prevent vitreous fluid from entering the subretinal/intraretinal space. In addition, the patients should be told that visual recovery can take a long time.