Clinical trial NCT00911924: A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
Official title: A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Keywords: primary open angle glaucoma (POAG)
OAG
glaucoma
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

Detailed description: One hundred patients will be enrolled in the study at up to 21 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 at least 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: IOP 18 mm Hg or less without medications
timeFrame: At 6 months
measure: IOP 18 mm Hg or less with or without medications
timeFrame: 12 months
Secondary outcomes:
measure: Mean IOP
timeFrame: 12 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan's Ophtalmology Centre
city: Wien
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Lyon
country: France
facility: Chu de Lyon Hospital Edouard Herriot
city: Paris
country: France
facility: CHNO des Quinze-Vingts
city: Paris
country: France
facility: Hopital Saint-Joseph
city: Bochum
country: Germany
facility: Knapschaftskrankenhaus Bochum Langendreer
city: Erlangen
country: Germany
facility: Universitatsklinkum Erlangen
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg A.o.R.
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum Neubrandenburg
city: Parma
country: Italy
facility: Universita' degli Studi di Parma
city: Torino
country: Italy
facility: Universita'di Torino
city: Madrid
country: Spain
facility: Hospital clinico San Carlos
city: Torrevieja
country: Spain
facility: Hospital Torrevieja Salud, UTE
Study officials:
affiliation: Glaukos Corporation
name: Jeff Wells, PharmD, MBA
role: STUDY_DIRECTOR
References:
citation: Voskanyan L, Garcia-Feijoo J, Belda JI, Fea A, Junemann A, Baudouin C; Synergy Study Group. Prospective, unmasked evaluation of the iStent(R) inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014 Feb;31(2):189-201. doi: 10.1007/s12325-014-0095-y. Epub 2014 Jan 23.