Impact of Different Intraocular Pressure and Medication Endpoint Criteria on Success Rates in Subconjunctival Minimally Invasive Glaucoma Surgery.
Tan Jeremy C K, Kong George, Louis Arnould, Lee Vincent, Clement Colin, Cheng Jason, Gazzard Gus, Lawlor Mitchell
AI Summary
Different success criteria for glaucoma surgery significantly alter reported failure rates, hindering outcome comparisons. Standardizing reporting is crucial for evaluating surgical effectiveness.
Abstract
Précis: Applying different combinations of intraocular pressure and medication endpoint criteria recommended by the World Glaucoma Association can have a significant influence on the risk of failure following glaucoma surgery, which hinders the comparison of outcomes.
Purpose
The definition of success in glaucoma surgical trials lacks standardization, leading to difficulty comparing outcomes across studies. This study evaluates how different intraocular pressure (IOP) and medication criteria affect success in a representative subconjunctival minimally invasive glaucoma surgery (MIGS) dataset.
Methods
A literature review identified the range of criteria used to define surgical success in studies of Xen gel stent, which were summarized into 4 definitions: (A) final IOP within upper and lower thresholds only, (B) criteria A plus ≥20% decrease in IOP verssus baseline, (C) ≥20% IOP decrease plus no increase in medications versus baseline, (D) all 3 criteria combined. These definitions were then applied to a cohort of 308 eyes that underwent Xen surgery to compare the apparent risks of failure.
Results
Success rates at 12 months across studies reviewed ranged from 18.5% to 33.4% for complete and 22.4% to 64.6% for qualified success. In our cohort, the hazard ratios of failure ranged from 0.27 to 5.87 (95% CI: 0.21-7.63, P <0.001) across the 4 definitions. The greatest degree of difference in apparent failure rates was observed at the upper IOP threshold of 21 mm Hg, and when evaluating qualified success.
Conclusion
Using different IOP and medication criteria to define success can have a significant influence on the apparent risk of failure, particularly at the 21 mm Hg threshold and when incorporating a minimum 20% IOP reduction from baseline. Reporting success using guidelines-recommended criteria-and at multiple upper IOP thresholds may enable better comparison of outcomes between studies.
MeSH Terms
Shields Classification
Key Concepts5
In a cohort of 308 eyes that underwent Xen surgery, the hazard ratios of failure ranged from 0.27 to 5.87 (95% CI: 0.21-7.63, P <0.001) across four different definitions of success (A: final IOP within upper and lower thresholds only; B: criteria A plus ≥20% decrease in IOP versus baseline; C: ≥20% IOP decrease plus no increase in medications versus baseline; D: all 3 criteria combined).
The greatest degree of difference in apparent failure rates for Xen surgery was observed at the upper intraocular pressure threshold of 21 mm Hg, and when evaluating qualified success.
Using different intraocular pressure and medication criteria to define success can have a significant influence on the apparent risk of failure following subconjunctival minimally invasive glaucoma surgery, particularly at the 21 mm Hg threshold and when incorporating a minimum 20% IOP reduction from baseline.
Applying different combinations of intraocular pressure and medication endpoint criteria recommended by the World Glaucoma Association can have a significant influence on the risk of failure following subconjunctival minimally invasive glaucoma surgery (MIGS), which hinders the comparison of outcomes.
Success rates at 12 months for Xen gel stent across reviewed studies ranged from 18.5% to 33.4% for complete success and 22.4% to 64.6% for qualified success.
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