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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 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 45 participants.

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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.

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2010-07
Est. Completion 2017-01-24

Sponsor

Vanderbilt University

430 total trials

What the Registry Record Tells You About NCT01162356

The ClinicalTrials.gov registry entry for NCT01162356 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01162356 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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