A large retrospective research was conducted by a team of investigators led by Michael H. Goldstein, MD, president of Ocular Therapeutix Inc., to identify the risk factors for endophthalmitis after cataract surgery.
The study used the IRIS Registry and found that complex cataract surgeries, simultaneous vitreous treatments, a history of diabetic macular edema or proliferative diabetic retinopathy, male sex, and particular cataract types were all linked to significantly increased risk of endophthalmitis.
Endophthalmitis is a bacterial or fungal infection inside the eye involving the vitreous and/or aqueous humors. Most cases are exogenous and occur after eye surgery, after penetrating ocular trauma, or as an extension of corneal infection.
Endophthalmitis may also be endogenous, arising from bacteraemic or fungaemic seeding of the eye.
The researchers also looked into whether using the ReSure Sealant had any effect on the rate of endophthalmitis. Following cataract surgery, this hydrogel sealant offers an in situ temporary soft surface barrier to prevent wound leaks from clear corneal incisions up to 3.5 mm in size.
The researchers compared the rate of endophthalmitis within 30 days after any cataract surgery performed with and without the ReSure Sealant, as well as the rate of endophthalmitis within 30 days of any cataract surgery performed in the United States.
Patients who had cataract surgery between January 1, 2016 and December 1, 2019 were included in this study. All of the patients received phacoemulsification with intraocular lens implantation and had one or more follow-up visits within 30 days of surgery.
The study contained data from almost 6,700,000 eyes (4.1 million patients; 58.9% women; mean age, 70.91 years). More than 3.5 million eyes were operated on in clinics that used the ReSure Sealant.
About 93% of cases were routine and the remainder were considered complex. Two-thirds of the cataracts were the nuclear sclerotic type, and the rest were cortical, posterior subcapsular, congenital, and traumatic.
Glaucoma procedures were performed concurrently in about 3.5% of cases and vitreous procedures in about 0.5% of cases. Slightly more than 20% of patients had a history of diabetes.
The overall incidence of endophthalmitis was 0.633 case per 1000 surgeries.
The incidence of endophthalmitis was significantly higher after complex procedure compared to routine procedures, ie, 1.148 vs. 0.592 case per 1000 surgeries, respectively (p < 0.0001).
Based on the use or no use of the ReSure Sealant, no significant difference was found in the incidence of endophthalmitis, i.e., 0.609 vs. 0.660, respectively.
The specific clinical risk factors that the data analysis identified in association with higher incidence rates of endophthalmitis were complex cataract procedures (odds ratio [OR], 1.67); concurrent vitreous procedures (OR, 4.32); traumatic (OR, 4.84), nuclear sclerotic (OR, 1.18), and posterior subcapsular (OR, 1.21) cataracts; and a history of proliferative diabetic retinopathy (OR, 1.53) or diabetic macular edema (OR, 2.04). Male sex (OR, 1.19) and multiethnicity (OR, 2.60) also were significant risk factors. All comparisons were significant (p < 0.0001).
“These results provide risk factors for endophthalmitis after cataract surgery from 2016 to 2019 and can identify patients at high risk of developing endophthalmitis after cataract surgery,” Goldstein concluded.