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Michael R Robinson, Davinder Grover, Kent P Bashford, Michael C Stiles, Jane Zhang, Rupali S Nangia, Jill Ling, Susan S Lee; Complete responders following ab interno gelatin stent at 12M in refractory glaucoma patients. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2056.
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To evaluate possible variables that contribute to IOP effectiveness not requiring adjunctive IOP lowering medications after implantation of an ab interno gelatin stent (XEN 45, Allergan) in refractory glaucoma patients.
At 12 months, complete responders were patients who achieved ≥20% IOP reduction from baseline and were medication-free, while non-complete responders were patients who required ≥1 IOP lowering medication. Post-hoc analysis of patient baseline characteristics, IOP and medication use at 12 months was conducted for each cohort. Univariate logistic regression models were examined to study the association between the chances being a complete responder and baseline variables of interest; odd ratios with 95% confidence intervals were reported to quantify the comparisons.
65 refractory glaucoma patients were enrolled in a multicenter clinical trial, 4 were lost to follow-up, 9 underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit and 52 completed the visit. Twenty patients (38%) met the complete responder criteria and 32 (62%) did not. At baseline, mean diurnal IOP and number of IOP lowering medications was 25.7±4.2 mmHg and 3.6±1.0 for complete responders, and 24.6±3.7 mmHg and 3.6±0.9 for non-complete responders. There were no significant differences between each cohort’s sex, race, mean diurnal IOP and number of medications at baseline. 53.8% vs. 33.3% of patients met complete responder criteria in patients age <60 years vs. >=60 years (OR 2.33, 95% CI 0.65, 8.37). Patients without prior incisional surgery had 2.56 (95% CI 0.80, 8.21) times higher odds of achieving the complete responder criteria. At 12 months, mean diurnal IOP was 13.4±1.9 mmHg for complete responders and 17.5±5.9 mmHg with 2.7±0.9 IOP lowering medications for non-complete responders.
While 75% of the study population reported ≥20% IOP reduction from baseline at 12 months (Grover et al, 2017), 38% of the patients who completed the 12-month visit averaged even greater IOP reduction and no adjunctive IOP lowering medications. Patients <60 years and naïve to incisional glaucoma surgeries had >2 times greater odds of being medication-free at 12 months with an IOP in the low teens, potentially indicating that enhanced gel stent outcomes may be related to earlier use in the glaucoma treatment paradigm.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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