Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study (PROVE)
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 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.
Vitreous Opacities or Hemorrhage
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy|
- Nerve fiber layer and macular changes after vitrectomy [ Time Frame: 3 month and annually for 5 years after surgery ] [ Designated as safety issue: Yes ]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.
- Visual field defects [ Time Frame: 3 month and annually for 5 years after surgery ] [ Designated as safety issue: Yes ]To characterize long-term functional consequences of NFL or macular changes with regards to peripheral and central visual field defects after PPV.
- Open-angle glaucoma [ Time Frame: 3 month and annually for 5 years after surgery ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162356
|United States, Tennessee|
|Vanderbilt Eye Institute|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Stephen J Kim, MD||Vanderbilt Eye Institute|
|Study Director:||Maziar Lalezary, MD||Vanderbilt Eye Institute|
|Study Director:||Rahul K Reddy, MD||Vanderbilt Eye Institute|