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Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study

NCT01162356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2017-02-23

No results posted yet for this 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.

Conditions

  • Glaucoma
  • Macular Pucker
  • Macula Hole
  • Vitreomacular Traction
  • Vitreous Opacities or Hemorrhage

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Stephen J Kim, MD · Vanderbilt Eye Institute

  • Maziar Lalezary, MD · Vanderbilt Eye Institute

  • Rahul K Reddy, MD · Vanderbilt Eye Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2017-01-24
Completion
2017-01-24

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01162356 on ClinicalTrials.gov