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The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.
The study design is as follows:
- Prospective, single-arm study.
- Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg.
- Subjects on two topical ocular hypotensive medications (one a prostaglandin).
- Implantation of two iStent inject devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued).
- IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP.
- Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout).
- Descriptive statistics will be tabulated.
- Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Implantation of two iStent inject micro-bypass stents, Topical travoprost, Two iStent inject micro-bypass stents, Tobramycin, Dexamethasone
S.V. Malayan's Ophtalmology Centre
Active, not recruiting
Published on BioPortfolio: 2016-08-23T12:23:22-0400
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