Abstract
Purpose :
Assess effectiveness of medication regimen in intraocular pressure (IOP) lowering pre/post-surgically in open-angle glaucoma (OAG) patients scheduled for canaloplasty and trabeculotomy combined with cataract surgery; evaluate relationship between medication number (meds) and IOP reduction.
Methods :
Prospective, multicenter, clinical study. Subjects were adults with cataract and mild/moderate OAG. Medicated IOP <33 mmHg on 1-4 meds at screening and post-washout mean diurnal IOP (DIOP) ≥21 and ≤36 mmHg. Subjects underwent medication washout (28 days for prostaglandin analogues, beta blockers, and rho kinase inhibitors, two weeks for alpha agonists, and five days for carbonic anhydrase inhibitors) prior to baseline and Month 12 IOP measurements. All IOP measurements were Goldmann (operator/reader protocol). DIOP was the mean of three timepoints (9AM, 12PM, 4PM). Descriptive statistics (Mean, SD) were calculated for screening medicated IOP, baseline DIOP, Month 12 medicated IOP, and washed out DIOP for all subjects and for subgroups on 1, 2, 3, 4 meds. Paired t-tests compared IOP post-washout pre-surgically and at Month 12 for all patients and for the medication subgroups. Simple linear regression evaluated the relationship between medication number and increase in IOP post-washout.
Results :
IOP increased 6.5 (2.8) mmHg (n=141) post-washout pre-surgically (p=0), and 6.0 (2.5) mmHg (1 med, n = 71), 5.9 (2.0) mmHg (2 meds, n = 36), 8.1 (3.4) mmHg (3 meds, n = 30), and 8.9 (3.9) mmHg (4 meds, n = 4). Meds were reintroduced for 22 subjects; 1 (n = 16), 2 (n = 5), or 3 (n = 1) meds. Average increases were 4.1 (all; p=.0024), 3.0 (1 med), and 5.8 mmHg (2 meds). A single patient on three meds went from 17.0 to 30.0 mmHg following washout, an increase of 13 mmHg.
Conclusions :
Medication washout results in increases in IOP correlated with number of meds in OAG patients. The results agree with independent results from the COMPASS and HORIZON trials (Johnson and Jampel, 2020) but extend the anaysis to medication washout IOP increase post-surgically. There is a diminished increase in IOP following washout post-surgically and an overall lower unmedicated IOP relative to pre-surgical IOP indicating 1) the surgical treatment provided an IOP-lowering benefit independent of the adjunctive medications and 2) that response to medication post-surgically may be diminished compared to surgically naive patients.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.