Glaucoma Prevalence and Glaucoma Surgical Considerations in Prosthetic Replacement of the Ocular Surface Ecosystem Device Use.

OBJECTIVES: The purpose of this study was to identify patients with glaucoma and corneal/ocular surface disease who have been fit with Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE; BostonSight, Needham, MA) devices and to understand the PROSE device fit experience in patients with glaucoma at Weill Cornell Medicine (WCM). METHODS: This is a retrospective chart review of patients older than 18 years who underwent PROSE device fitting at WCM. Records were reviewed for demographic information and ophthalmic variables. Descriptive statistics were performed. RESULTS: Between 2011 and 2017, 281 patients underwent PROSE device fitting at WCM, of whom 24 patients (8.5%) had a glaucoma diagnosis and 17 patients (6.0%) were identified as glaucoma suspect. Ocular surface disease was the most common indication for PROSE device wear (58.3%). Five patients had a history of incisional glaucoma surgery in the eye undergoing PROSE device fitting: three valved glaucoma drainage implants and two trabeculectomies. Three of these eyes were successfully fit with PROSE devices. CONCLUSIONS: Patients fitted with Prosthetic Replacement of the Ocular Surface Ecosystem devices at WCM had a higher prevalence of glaucoma than in the general population. Among patients with incisional glaucoma surgery, PROSE device fitting was challenging, with a 40% failure rate.

Adverse events associated with femtosecond laser-assisted cataract surgery reported to the MAUDE database.

PURPOSE: To report real-world complications associated with femtosecond laser-assisted cataract surgery (FLACS). SETTING: Deidentified database. DESIGN: Retrospective review. METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was culled for adverse events involving ophthalmic femtosecond laser during cataract surgery from January 2010 to January 2020. Reports in which the narrative description was inadequate to determine the nature of the complication were excluded. Each report was reviewed for complications, which were subsequently assigned to a complication category as determined by these authors. The number of events per year was determined and compared. RESULTS: Between January 2010 and January 2020, the MAUDE database search yielded 2927 reports involving femtosecond laser, of which 1927 met inclusion criteria and were included for analysis. These reports revealed 2704 complications: 1115 capsule tears (41.2%), 329 of which required vitrectomy, 372 instances of suction loss, 321 other capsulotomy-related complications, and 432 corneal or incisional complications. Rare complications included 54 reports of miosis, 16 reports of endophthalmitis, and 4 reports of toxic anterior segment syndrome. The number of events in the MAUDE database increased year over year between 2011 and 2017, peaking in 2017 at 303 events. CONCLUSIONS: By drawing on real-world data in the MAUDE database, this study identified the complications of greatest importance in clinical practice. Surgeons should be aware of the spectrum of possible complications to best prepare for all potential outcomes and to effectively counsel patients.

Tissue Loss, Processing Time, and Primary Graft Failure in Eye Bank-Prepared Descemet Membrane Endothelial Keratoplasty Grafts Before and After Prestripped to Preloaded Graft Transition.

PURPOSE: To examine tissue loss rates, processing time, and primary graft failure (PGF) of "prestripped-only" Descemet membrane endothelial keratoplasty (DMEK) grafts at a single eye bank and how these parameters changed after the introduction of steps to preload tissue among experienced processors. METHODS: Tissue loss and processing time during DMEK graft preparation as well as PGF were analyzed retrospectively at a single eye bank between 2012 and 2018. Outcomes were assessed in consecutive grafts before and after the introduction of preloading to the eye bank's standard operating procedure. RESULTS: A total of 1326 grafts were analyzed, composed of the first 663 preloaded DMEK grafts and, for comparison, the 663 DMEK grafts processed immediately before starting the preloaded service. Mean processing time increased from 17.0 ± 3.9 minutes to 26.0 ± 5.4 minutes with the advent of preloading (P < 0.01). Initially, average processing time increased dramatically, with a maximum processing time of 51 minutes, before regressing to the average. No significant difference in the rate of tissue wastage was observed before versus after the implementation of preloaded DMEK (1.2% vs. 1.7%, P = 0.48). PGF occurred in 7 grafts before the preloaded service and 10 grafts after starting the service (1.6% vs. 2.3%, P = 0.47). CONCLUSIONS: Preloading does not affect tissue wastage for experienced technicians or the PGF rate but increases processing time. Eye banks that are considering adding preloading to their standard operating procedure may need to account for longer processing times in their daily operations.

Primary Graft Failure, Infection, and Endothelial Cell Density in Corneal Transplants With Increased Death-to-Preservation Time.

PURPOSE: To ascertain whether death-to-preservation time (DPT) is associated with donor endothelial cell density (ECD), primary graft failure (PGF), and infection. METHODS: Donor corneas aged older than 10 years with ECD 2000 to 4500 cells/mm2 were procured between 2011 and 2018 by a single eye bank. Donor corneas were analyzed retrospectively for the main outcome measures of PGF, infection, and ECD. Means and proportions of study parameters were compared between corneas with long and short DPT, defined as greater or less than 14 hours, respectively, excluding corneas with a history of intraocular surgery or diabetes. Multivariate analyses were performed using logistic regression, adjusting for donor age at time of death, history of diabetes mellitus, and history of cataract surgery. RESULTS: Among 12,015 corneas, those with long DPT had a statistically but not clinically significant higher ECD than that of corneas with short DPT (2754 vs. 2724 cells/mm2, P < 0.01). There was no difference in PGF and infections in corneas with long versus short DPT (0.28% vs. 0.26%, P = 0.86; 0.43% vs. 0.29%, P = 0.51, respectively). CONCLUSIONS: Longer DPT is not associated with a clinically meaningful reduction in donor ECD, PGF, or infection.