Clinical trial NCT00913029: Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)
Official title: A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eye Diseases
Glaucoma, Open-Angle
Glaucoma
Keywords: primary open angle glaucoma (POAG)
OAG
glaucoma
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

Eligibility criteria: 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

Primary outcomes:
measure: Mean intraocular pressure (IOP)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: SV Malayan Ophthalmological Center
city: Wien
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Lyon
country: France
facility: CHU de Lyon Hopital Edouard Herriot
city: Paris
country: France
facility: CHNO des Quinze-Vingts
city: Bochum
country: Germany
facility: Knapschaftskrankenhaus Bochum Langendreer
city: Erfurt
country: Germany
facility: Helios Cliniic
city: Erlangen
country: Germany
facility: Universitatsklinkum Erlangen
city: Thessaloniki
country: Greece
facility: AHEPA Hospital
city: Parma
country: Italy
facility: Universita'degli Studi di Parma
city: Torino
country: Italy
facility: Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica
city: Udine
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordia
city: Warsaw
country: Poland
facility: Military Health Service Institute
city: Alicante
country: Spain
facility: Hospital Torrevieja Salud, UTE
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Bedford
country: United Kingdom
facility: Hinchingbrooke Hospital Moorfields
Study officials:
affiliation: Glaukos Corporation
name: Jeff Wells, PharmD, MBA
role: STUDY_DIRECTOR
References:
citation: Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject ((R)) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.