Glaucoma Clinical Trial
— SLOfficial title:
A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
Status | Completed |
Enrollment | 192 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of primary open-angle glaucoma - Male or female at least 18 years of age and able to provide written informed consent - Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg - Likely to be available and willing to attend follow-up visits Exclusion Criteria: - Angle closure glaucoma - Secondary glaucomas - Prior glaucoma procedures - Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Armenia | SV Malayan Ophthalmological Center | Yerevan | |
Austria | Allgemeines Krankenhaus Wien | Wien | |
France | CHU de Lyon Hopital Edouard Herriot | Lyon | |
France | CHNO des Quinze-Vingts | Paris | |
Germany | Knapschaftskrankenhaus Bochum Langendreer | Bochum | |
Germany | Helios Cliniic | Erfurt | |
Germany | Universitatsklinkum Erlangen | Erlangen | |
Greece | AHEPA Hospital | Thessaloniki | |
Italy | Universita'degli Studi di Parma | Parma | |
Italy | Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica | Torino | |
Italy | Azienda Ospedaliera S. Maria della Misericordia | Udine | |
Poland | Military Health Service Institute | Warsaw | |
Spain | Hospital Torrevieja Salud, UTE | Alicante | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
United Kingdom | Hinchingbrooke Hospital Moorfields | Bedford |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
Armenia, Austria, France, Germany, Greece, Italy, Poland, Spain, United Kingdom,
Fea AM, Belda JI, Rekas M, Jünemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May — View Citation
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Primary | Mean intraocular pressure (IOP) | 1 year | No |
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