Glaucoma Clinical Trial
— SYOfficial title:
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
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 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Armenia | S.V. Malayan's Ophtalmology Centre | Yerevan | |
Austria | Allgemeines Krankenhaus Wien | Wien | |
France | Chu de Lyon Hospital Edouard Herriot | Lyon | |
France | CHNO des Quinze-Vingts | Paris | |
France | Hopital Saint-Joseph | Paris | |
Germany | Knapschaftskrankenhaus Bochum Langendreer | Bochum | |
Germany | Universitatsklinkum Erlangen | Erlangen | |
Germany | Universitatsklinikum Magdeburg A.o.R. | Magdeburg | |
Germany | Dietrich-Bonhoeffer-Klinikum Neubrandenburg | Neubrandenburg | |
Italy | Universita' degli Studi di Parma | Parma | |
Italy | Universita'di Torino | Torino | |
Spain | Hospital clinico San Carlos | Madrid | |
Spain | Hospital Torrevieja Salud, UTE | Torrevieja |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
Armenia, Austria, France, Germany, Italy, Spain,
Voskanyan L, García-Feijoó J, Belda JI, Fea A, Jünemann A, Baudouin C; Synergy Study Group. Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014 Feb;31(2):189-201. doi: 10.1007/s12325-014-009 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IOP 18 mm Hg or less without medications | At 6 months | No | |
Primary | IOP 18 mm Hg or less with or without medications | 12 months | No | |
Secondary | Mean IOP | 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06000865 -
Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE
|
N/A | |
Recruiting |
NCT06278597 -
Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device
|
N/A | |
Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
Recruiting |
NCT03274024 -
The Asia Primary Tube Versus Trab (TVT) Study
|
N/A | |
Completed |
NCT04552964 -
Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma
|
N/A | |
Recruiting |
NCT01957267 -
Functional and Structural Imaging for Glaucoma
|
||
Active, not recruiting |
NCT04624698 -
iStent Inject New Enrollment Post-Approval Study
|
N/A | |
Completed |
NCT04020705 -
The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma
|
N/A | |
Completed |
NCT03150160 -
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
|
Phase 4 | |
Not yet recruiting |
NCT05581498 -
Glaucoma Exercise as Medicine Study (GEMS).
|
N/A | |
Recruiting |
NCT02921568 -
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
|
N/A | |
Active, not recruiting |
NCT02901730 -
Clinical Study of LPI With Different Laser Wavelengths
|
N/A | |
Completed |
NCT02955849 -
A Trial of China Laser and Surgery Study Glaucoma in Rural China
|
Early Phase 1 | |
Recruiting |
NCT02471105 -
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
|
Phase 4 | |
Recruiting |
NCT02554214 -
Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device
|
N/A | |
Active, not recruiting |
NCT02390284 -
Stop Retinal Ganglion Cell Dysfunction Study
|
Phase 3 | |
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Completed |
NCT02653963 -
Triamcinolone for Ahmed Glaucoma Valve
|
N/A | |
Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
Completed |
NCT02520674 -
Glaucoma Screening With Smartphone Ophthalmology
|
N/A |