Glaucoma Clinical Trial
Official title:
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.
The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation. The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up. Patients will be randomized to 2 tube locations for GDD implantation: - Tube placed in the AC - Tube placed in ciliary sulcus - Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation. ;
| 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 |
NCT02554214 -
Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device
|
N/A | |
| Recruiting |
NCT02471105 -
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
|
Phase 4 | |
| Active, not recruiting |
NCT02390284 -
Stop Retinal Ganglion Cell Dysfunction Study
|
Phase 3 | |
| Completed |
NCT02653963 -
Triamcinolone for Ahmed Glaucoma Valve
|
N/A | |
| Completed |
NCT02520674 -
Glaucoma Screening With Smartphone Ophthalmology
|
N/A | |
| Completed |
NCT02246764 -
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 3 | |
| Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A |