Overview

This trial is active, not recruiting.

Conditions glaucoma, macular pucker, macula hole, vitreomacular traction, vitreous opacities or hemorrhage
Sponsor Vanderbilt University
Start date July 2010
End date December 2017
Trial size 40 participants
Trial identifier NCT01162356, 100073

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Nerve fiber layer and macular changes after vitrectomy
time frame: 3 month and annually for 5 years after surgery

Secondary Outcomes

Measure
Visual field defects
time frame: 3 month and annually for 5 years after surgery
Open-angle glaucoma
time frame: 3 month and annually for 5 years after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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 neovacular membrane

Additional Information

Official title A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy
Principal investigator Stephen J Kim, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.