24 Month Real-World Study Of Intraocular Eye Pressure And Medication Reduction In Ab Interno Microinvasive Glaucoma Surgery Combined With Cataract Surgery Compared With Cataract Surgery Only: An Iris® Registry Study
Published 2023 - 41st Congress of the ESCRS
Reference: FP16.02 | Type: Free paper | DOI: 10.82333/3f8f-zc74
Authors: Andrew Tatham* 1 , Richard Chapman 2 , Kristian Garcia 2 , Cristina Masseria 3 , John Liu 4 , Jaime Dickerson 5 , Michael Mbagwu 6
1Princess Alexandra Eye Pavilion,Edinburgh,United Kingdom, 2Verana Health,San Francisco,United States, 3Aesara,Chapel Hill,United States, 4Sight Sciences,Menlo Park ,United States, 5Sight Sciences,Menlo Park ,United States;North Texas Eye Research Institute, University of North Texas Health Science Center,Fort Worth,United States, 6Verana Health,San Francisco,United States;Stanford University School of Medicine,Palo Alto,United States
Purpose
Minimally Invasive Glaucoma Surgery (MIGS) adoption has increased significantly in recent years, despite the limited comparative and longer term (i.e., > 12 months) safety or effectiveness data. The purpose of our study was to compare real world clinical outcomes over time for glaucoma patients undergoing implantable or implant-free FDA cleared or approved ab interno MIGS combined with cataract surgery, and cataract surgery alone in the United States (US), using the American Academy of Ophthalmology (Academy) IRIS® Registry curated data.
Setting
The IRIS Registry is the largest electronic health record based comprehensive eye disease and condition registry in the US. After applying study criteria, 109,745 eyes were included in the analysis who either underwent a cataract procedure only or combined MIGS and cataract procedure during the study period 2018-2020.
Methods
Retrospective analysis of data from the IRIS Registry linked to Komodo Health medication claims dataset, July 1, 2016- June 30, 2022. Eligible patients had valid intraocular pressure (IOP) measurements and an ICD-10 diagnosis of moderate to severe glaucoma. There were four cohorts: OMNI®, Hydrus® microstent, iStent® Inject(all in combination with cataract surgery) and cataract surgery only. Primary outcomes were change in IOP and number of IOP-lowering medication classes at 6, 12, 18, and 24 months. Paired t-tests, two-proportion z-tests, and Bonferroni correction was used to analyze significance within and across cohorts. Analysis was stratified by baseline IOP: > 18 mm Hg (Group 1) and ≤ 18 mm Hg (Group 2).
Results
Group 1: Mean reductions (standard deviation, SD) from baseline in IOP at 24 months were 6.64 (7.59), 5.71 (6.30), 4.96 (7.30), and 5.55 (6.41) mm Hg for OMNI, Hydrus, iStent inject and cataract surgery only, respectively. Medication class reductions (SD) were 1.34 (1.48), 1.20 (1.18), 0.86 (1.10), and 0.67 (1.10). Group 2: IOP reductions were overall small as expected in this group with low baseline IOP. Mean reductions (SD) from baseline in IOP at 24 months were 0.47 (4.51), 0.03 (3.69), 0.17 (3.34), and 0.07 (3.77) mm Hg for OMNI, Hydrus, iStent inject and cataract surgery only, respectively. Medication class reductions were 1.14 (1.22), 1.18 (1.22), 0.95 (1.05), and 0.65 (1.06).
Conclusions
MIGS were found to benefit glaucoma patients overall when compared to cataract surgery alone, but with some differences observed in MIGS effectiveness. This RWE study provides longer term comparative effectiveness evidence for three FDA approved or cleared commonly used MIGS devices. Results are consistent with multiple published studies of individual MIGS and suggest better outcomes for those who received MIGS with cataract surgery, compared to those who received cataract surgery alone.