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Risk Calculation in the Medication Arm of the Ocular Hypertension Treatment Study
Ari Leshno1, Carlos Gustavo De Moraes2, George A Cioffi2
1Bernard and Shirlee Brown Glaucoma Research Laboratory, Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia University Irving Medical Center, New York, New York; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Purpose:
Risk assessment is integral to the management of individuals with ocular hypertension (OHTN). This study aims to determine the predictive accuracy of the Ocular Hypertension Treatment Study 5-year risk calculator (OHTS calculator) among treated patients with OHTN by applying it to patients randomized to the Ocular Hypertension Treatment Study (OHTS) medication arm.
Design:
Post hoc secondary analysis of a randomized clinical trial.
Subjects:
Individuals participating in the OHTS who were randomized to the medication arm. Only participants with complete baseline data in both eyes were included (n = 726).
Methods:
The hazard ratios (HRs) of the medication group in OHTS were compared to the HR used for the OHTS calculator using the z-test statistic to establish the OHTS calculator's generalizability to the OHTS medication arm. The performance of the OHTS calculator among the OHTS medication group was evaluated twice, using both untreated baseline intraocular pressure (IOP) and average treated IOP during the first 24 months for the IOP variable.
Main Outcome Measures:
The performance was determined based on the model's accuracy in estimating the risk of reaching an OHTS primary open-angle glaucoma (POAG) end point using calibration chi-square and discriminating between participants who did or did not develop POAG.
Results:
The HRs for the OHTS medication arm were not significantly different from those used in the OHTS calculator for untreated OHTN derived from observation arm data (P > 0.1). Based on the calibration chi-square test for the medication group, the OHTS calculator prediction model had good predictive accuracy when using the mean treated IOP and poorer predictive accuracy with the untreated baseline IOP (chi-square 10 and 29, respectively). The model had good discrimination with treated IOP (c-statistic = 0.77), comparable to what has been reported for the OHTS calculator in the OHTS observation group.
Conclusions:
The OHTS calculator can be applied to treated patients with OHTN, and repeat risk calculation after initiating IOP reduction may provide useful information that can aid in disease management.
Financial Disclosure(S):
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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