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NCT Number: NCT01162356

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt Eye Institute

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to consent and comply for the duration of the study and imaging studies
  • Media clarity sufficient for imaging studies
  • No previous treatment or surgery that might confound study results in the study or fellow eye
  • Pars plana vitrectomy (PPV) indicated for epiretinal membrane (ERM), macular hole (MH), vitreo-macular traction (VMT), and vitreous hemorrhage (VH)

Exclusion criteria

  • Unable to consent and/or comply for the duration of the study and imaging studies
  • History of the following conditions: Glaucoma or associated conditions, visual field defects, uveitis, age-related macular degeneration (ARMD), prior PPV for retinal detachment, retained lens or dislocated intraocular lens
  • Contralateral eye status post PPV or with advanced eye disease serious enough to warrant future PPV - Contralateral eye with condition that may result in choroidal neovascular membrane

Treatment and study plan

Primary outcomes

  1. Nerve fiber layer and macular changes after vitrectomy

    Time frame: 3 month and annually for 5 years after surgery

    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.

Secondary outcomes

  1. Visual field defects

    Time frame: 3 month and annually for 5 years after surgery

    To characterize long-term functional consequences of NFL or macular changes with regards to peripheral and central visual field defects after PPV.

  2. Open-angle glaucoma

    Time frame: 3 month and annually for 5 years after surgery

    To determine the incidence of elevated intraocular pressure and open-angle glaucoma following vitrectomy. Enrolled patients will be screened at baseline to exclude pre-existing glaucoma and post-operative glaucoma screenings will be performed by fellowship trained glaucoma specialist.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy

Acronym: PROVE

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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