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NCT01162356 · ClinicalTrials.gov registry record
Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study
A clinical trial, sponsored by Vanderbilt University.
- Completed
- Registry status
- 45
- Enrollment target
NCT01162356: Completed study, sponsored by Vanderbilt University.
NCT01162356 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01162356 has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
Since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed annually in the United States and indications continue to expand. Known long-term complications of vitrectomy are relatively few and include retinal detachment and cataract formation. Although much has been written in the literature concerning acute rises in intraocular pressure (IOP) in the immediate postoperative period, there is surprisingly little information on long term IOP outcomes after vitrectomy. A recent report by Chang given at the LXII (62) Edward Jackson Memorial Lecture hypothesized a causal relationship between vitrectomy and open-angle glaucoma (OAG) via oxidative stress exacerbated by removal of the crystalline lens. A second report by Luk and colleagues reported similar conclusions in a modified cohort. Both studies, were retrospective in nature and did not perform baseline evaluations to exclude pre-existing glaucoma. Furthermore neither study accounted for natural history. Finally, our analysis has not reproduced similar results. The primary purpose of this study is to analyze the full spectrum of optic nerve and macular changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control for natural history. Baseline evaluations will include examination by fellowship trained retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence tomography (macula and optic nerve) and automated visual field testing. At 3 month then annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.
Primary Outcome
To determine the incidence of nerve fiber layer (NFL) and macular changes after pars plana vitrectomy, characterize their extent and quality, and determine pre-disposing risk factors.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-07 |
| Est. Completion | 2017-01-24 |
What the finished NCT01162356 record still lists
NCT01162356 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01162356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01162356 about?
NCT01162356 is a clinical study titled "Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study". Since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed annually in the United States and indications continue to expand. Known long-term complications of vitrectomy are relativel...
What is the current status of trial NCT01162356?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2010-07. Estimated completion is 2017-01-24.
Who is sponsoring clinical trial NCT01162356?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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