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NCT00666237 · ClinicalTrials.gov registry record · Phase 4
Primary Tube Versus Trabeculectomy Study
A Phase 4 study of Glaucoma, sponsored by University of Miami.
- Completed
- Registry status
- Phase 4
- Development phase
- 242
- Enrollment target
- 16
- Study locations
NCT00666237: Completed Phase 4 study of Glaucoma, sponsored by University of Miami.
NCT00666237 is a Phase 4 study of Glaucoma that has completed, run by University of Miami. The registered enrollment target is 242 participants, below the 908-participant average among 92 other Glaucoma trials with a reported enrollment target (73% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00666237, a Phase 4 study of Glaucoma, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 242 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.
Primary Outcome
Surgical failure is defined as: 1. Inadequate Intraocular Pressure (IOP) Reduction (IOP \> 21 mmHg or reduced \< 20% below baseline on 2 consecutive follow-up visits after 3 months) 2. Reoperation for glaucoma 3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) 4. Loss of light perception vision
Conditions Studied
Interventions
- DRUG Mitomycin C
- PROCEDURE Tube shunt surgery
- PROCEDURE Trabeculectomy
Study Locations (16)
Other
- University of Toronto - Toronto
- Moorfields Eye Hospital - London
- St. Thomas' Hospital - London
- Queen Mary's Sidcup Hospital - Sidcup
Florida
- University of Florida - Gainesville
- Bascom Palmer Eye Institute - Miami
Texas
- Glaucoma Associates of Texas - Dallas
- University of Texas, Houston - Houston
California
- University of California Davis Medical Center - Sacramento
Maryland
- Johns Hopkins - Baltimore
Missouri
- St. Louis University - St Louis
New York
- New York Eye and Ear Infirmary - New York
Ohio
- Cincinnati Eye Institute - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2008-04-01 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 4 |
What the finished NCT00666237 record still lists
NCT00666237 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 908-participant average among 92 other Glaucoma trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Glaucoma appearing as the primary indexed condition, and to 3 interventions - of which Mitomycin C is the first listed.
NCT00666237 lists 16 locations in 11 states (Other, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT00666237 about?
NCT00666237 is a clinical study titled "Primary Tube Versus Trabeculectomy Study". The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.
What is the current status of trial NCT00666237?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 242 participants. The study started on 2008-04-01. Estimated completion is 2021-04-01.
What conditions does trial NCT00666237 study?
This clinical trial studies the following conditions: Glaucoma.
What interventions are being tested in trial NCT00666237?
The interventions under investigation include: Mitomycin C (DRUG), Tube shunt surgery (PROCEDURE), Trabeculectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00666237?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00666237 being conducted?
This trial has 16 study locations across California, Florida, Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glaucoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00666237's enrollment target sits among peer trials
242 23rd of 92 higher than 70 of 92 other Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glaucoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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