Outcomes in cataract surgery using ReSure® Sealant for the intraoperative management of clear corneal incisions:
Results from a registry evaluation for pre-specified adverse ocular events

Abstract

Purpose : To collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with ReSure Sealant.

Methods : This was a prospective, multicenter, single-arm observational post-approval registry study, conducted at up to 40 sites in the United States. Patients were eligible for inclusion in the study if they were greater than or equal to 22 years of age, had a cataract and were expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens. ReSure Sealant was prepared and applied in accordance with the product’s accompanying Instructions for Use. The primary endpoints were the proportion of patients experiencing persistent anterior chamber cells, hypotony, ocular discomfort, and surgical re-intervention in the postoperative follow-up period; achievement of the primary endpoint was based on statistical analysis of the true proportion of eyes exhibiting any adverse ocular event occurring less than or equal to 7.5%.

Results : A total of 12 endpoint adverse ocular events were reported for 12 subjects within the cohort of 626 subjects (1.9%). The frequency of each of the primary endpoint events was low (range 0 to 0.8%). The true proportion of each primary endpoint event is less than 0.075. None of the primary endpoint events were attributed to the application of the ReSure Sealant and no event was deemed to be serious. Seven of the 12 events observed within the course of this study were mild, and the remaining 5 events were of moderate intensity. None of the events were of severe intensity. Eleven of the 12 events were determined to be related to the cataract surgery.

Conclusions : The results of the primary analysis demonstrate that the true proportion of the frequency of primary endpoint Adverse Ocular Events was well below the pre-specified threshold of 7.5%. Results of this registry confirm that the ReSure Sealant can be used safely by ophthalmologists.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Frequency and Intensity of Primary Endpoint Analysis of Adverse Ocular Events

 

Overall Summary of Adverse Ocular Events