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Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

2016-08-23 12:23:22 | BioPortfolio

Summary

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.

Description

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Open-angle Glaucoma

Intervention

Implantation of two iStent inject micro-bypass stents, Topical travoprost, Two iStent inject micro-bypass stents, Tobramycin, Dexamethasone

Location

S.V. Malayan's Ophtalmology Centre
Yerevan
Armenia
375108

Status

Active, not recruiting

Source

Glaukos Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-23T12:23:22-0400

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Ophthalmology
Ophthalmology is the branch of medicine that is devoted to the study and treatment of eye diseases. As well as mild visual defects correctable by lenses, ophthalmology is concerned with glaucoma, uveitis and other serious conditions affecting the eye, ...


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