Ciliary neurotrophic factor delivered by encapsulated cell intraocular implants for treatment of geographic atrophy in age-related macular degeneration.

There is no treatment available for vision loss associated with advanced dry age-related macular degeneration (AMD) or geographic atrophy (GA). In a pilot, proof of concept phase 2 study, we evaluated ciliary neurotrophic factor (CNTF) delivered via an intraocular encapsulated cell technology implant for the treatment of GA. We designed a multicenter, 1-y, double-masked, sham-controlled dose-ranging study. Patients with GA were randomly assigned to receive a high-or low-dose implant or sham surgery. The primary endpoint was the change in best corrected visual acuity (BCVA) at 12 mo. CNTF treatment resulted in a dose-dependent increase in retinal thickness. This change was followed by visual acuity stabilization (loss of less than 15 letters) in the high-dose group (96.3%) compared with low-dose (83.3%) and sham (75%) group. A subgroup analysis of those with baseline BCVA at 20/63 or better revealed that 100% of patients in the high-dose group lost <15 letters compared with 55.6% in the combined low-dose/sham group (P = 0.033). There was a 0.8 mean letter gain in the high-dose group compared with a 9.7 mean letter loss in the combined low-dose/sham group (P = 0.0315). Both the implant and the implant procedure were well-tolerated. These findings suggest that CNTF delivered by the encapsulated cell technology implant appears to slow the progression of vision loss in GA, especially in eyes with 20/63 or better vision at baseline.

OFFICE MANAGEMENT OF OZURDEX IMPLANT DISLOCATION INTO THE ANTERIOR CHAMBER.

PURPOSE: To describe a novel office procedure that permits the repositioning of an Ozurdex implant from the anterior chamber back into the vitreous cavity. METHODS: Description of an office technique for Ozurdex repositioning using a 30-gauge needle. RESULTS: In both cases, the Ozurdex implant was successfully returned to the vitreous cavity. In Case 1, the patient's visual acuities 1 and 2 weeks after this were 20/70 and 20/40, respectively, and had no further complications. In Case 2, the patient returned 1 week later, with the implant remaining posterior and a visual acuity of 20/40. CONCLUSION: The success of this novel technique in these cases demonstrates the potential to avoid a surgical procedure in the event of Ozurdex implant migration to the anterior chamber, while at the same time allowing the Ozurdex implant to remain effective in the eye.

Infusion Misdirection in Microincisional Vitrectomy Surgery.

PURPOSE: To review the incidence and possible mechanisms of 2 problems caused by infusion misdirection during microincisional vitrectomy in 1 physician's practice and to find an estimate of the broader occurrence among other physicians. DESIGN: Observational series of 1 surgeon's cases over 2 periods. A survey also was sent to other retinal specialists. PARTICIPANTS: Patients undergoing microincisional vitrectomy. METHODS: The physician tracked the occurrence of intraoperative hypotony and unintentional anterior chamber air infusion in his practice. A survey was sent to 2000 members of the American Society of Retina Specialists and the Retina Society. MAIN OUTCOME MEASURES: Primary outcome measure was the incidence of hypotony during microincisional vitrectomy, defined as softening of the globe to the point of corneal or scleral infolding, or both, that resolved with repositioning of the infusion cannula. The secondary outcome measure was incidence of unplanned air flow into the anterior chamber. Survey questions included frequency of observed infusion interruption and incidence of inadvertent anterior chamber air infusion. RESULTS: In the earlier series, of 232 vitrectomies, 37 (16%) showed signs of episodic hypotony after infusion blockage. Seven cases (3%) showed inadvertent air flow into the anterior chamber. One hundred fifty-two physicians responded to the survey. Fifty-seven percent reported infusion blockage and hypotony in 1% to 5% of cases. Fifty-nine percent reported air flow into the anterior chamber in some cases. In the later series, 12 instances of infusion blockage were noted in 118 cases. Awareness of the issue and additional attention to the infusion line taping did not prevent the problem from occurring. In the survey, most respondents reported observing both infusion interruption and inadvertent anterior chamber air infusion on occasion. CONCLUSIONS: Infusion misdirection resulting in hypotony or air flow into the anterior chamber seems to be infrequent, but it remains a risk. Awareness of the problem reduces the incidence, but does not eliminate it. The potential inadvertently to touch the retina, choroid, or lens increases when these events occur. Infusion misdirection can be avoided by maintaining the correct position of the cannula, which may be facilitated by an external support to the tubing.

Disease Burden in the Treatment of Age-Related Macular Degeneration: Findings From a Time-and-Motion Study.

PURPOSE: To examine the time burden of managing neovascular age-related macular degeneration (AMD) imposed on physicians, staff, patients, and caregivers. DESIGN: Mixed-methods, prospective, observational time-and-motion study. METHODS: The multicenter study was conducted from March 2011 through August 2012. Retina specialists administering ≥50 vascular endothelial growth factor (VEGF)-inhibitor injections monthly were surveyed and completed records for ≥5 patients scheduled for office visits within 3 weeks for anti-VEGF injection or monitoring. A survey was administered to 75 neovascular AMD patients aged ≥50 years who received ≥1 anti-VEGF injection in the past 6 months. Telephone interviews were conducted with 13 neovascular AMD patient caregivers. RESULTS: Fifty-six physicians provided data for 221 patients with neovascular AMD. Patients accounted for 20% of the health care staff's time per week, with an average of 23 staff members. An average patient visit for neovascular AMD was 90 minutes (range: 13 minutes to >4 hours). Patients reported an average time per visit of almost 12 hours, including preappointment preparation (16 minutes), travel (66 minutes), waiting time (37 minutes), treatment time (43 minutes), and postappointment recovery (9 hours). Patients stated that caregivers took time away from work (22%) and personal activities (28%) to provide transportation to appointments. CONCLUSIONS: Neovascular AMD management imposes a substantial time burden on physicians, staff, patients, and caregivers. There may be a need for additional support and/or reimbursement for services required by patients and caregivers and provided by physicians.

Complications of general anesthesia using nitrous oxide in eyes with preexisting gas bubbles.

PURPOSE: To present the visual and anatomical outcomes for patients with intraocular gas placed during vitreoretinal surgery who subsequently underwent surgery wherein general anesthesia with nitrous oxide was used. METHODS: The authors reviewed the charts of patients who had undergone vitreoretinal surgery where a long-acting gas tamponade had been used. These patients underwent additional surgery for a variety of reasons at five different institutions and had nitrous oxide used during general anesthesia. The authors reviewed the preoperative and postoperative findings for patients receiving nitrous oxide following vitreoretinal surgery with gas tamponade. RESULTS: The authors reviewed findings for five eyes of five patients. All eyes that underwent general anesthesia using nitrous oxide had significant preexisting intraocular gas bubbles ranging from 40% to 90%, and the surgical procedures lasted from 1 to 4 hours. These eyes were followed from 2 months to 9 years (median follow-up, 4 years). Four of five eyes had a final vision of 20/200 or worse and significant optic atrophy at the time of the last follow-up examination. Three eyes had no light perception. CONCLUSION: The use of nitrous oxide during general anesthesia in gas-filled eyes may have disastrous visual results caused by gas expansion and elevated intraocular pressure. Patients must be advised of the potentially catastrophic results of undergoing general anesthesia before their intraocular gas bubble has resorbed. The use of nitrous oxide for patients with intraocular gas should be avoided. It may be prudent for patients with intraocular gas to wear notification bracelets warning anesthesiologists about the presence of intraocular gas lest emergency surgery be needed by a patient unable to advise anesthesia personnel about the potential danger.

Office-based sutureless transconjunctival pars plana vitrectomy.

PURPOSE: This is a preliminary report to describe our technique of office-based vitrectomy (OVIT) and to report the incidence of complications over a 6-year period. METHODS: In a retrospective, noncomparative case series, OVIT was performed on 225 patients in four participating offices. Each patient was operated on with a 23-gauge vitreous cutter that the authors have developed. They have also developed a 23-gauge transconjunctival infusion needle device. Diagnoses included endophthalmitis, uveitis, intravitreal lens fragments, ghost cell glaucoma, and rhegmatogenous retinal detachment. RESULTS: The surgical goal was accomplished in all cases, but supplemental office procedures were required for two eyes, and a scleral buckle was necessary in one eye. There were 15 complications in 14 eyes: "fish-egg" gas bubbles (one eye), intraocular hemorrhage (nine eyes), choroidal detachment (two eyes), new retinal breaks (one eye), retinal detachment (one eye), and temporary elevation of intraocular pressure (one eye). The hemorrhages, choroidal detachments, and fish-egg bubbles all resolved spontaneously. CONCLUSION: Office-based sutureless transconjunctival pars plana vitrectomy, with infusion when needed, is an effective operation for selected diseases of the posterior segment. In a multicenter series of 225 eyes, there were 15 complications in 14 (6%) eyes. Two of the complications were successfully managed with additional office procedures; one was managed in the operating room; and 12 resolved spontaneously.