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Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01162356
Acronym
PROVE
Enrollment
45
Registered
2010-07-14
Start date
2010-07-31
Completion date
2017-01-24
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Vitrectomy, Glaucoma, Macula, Optic nerve, Ocular Coherence Tomography

Brief 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.

Interventions

None listed

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Nerve fiber layer and macular changes after vitrectomy3 month and annually for 5 years after surgeryTo 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

MeasureTime frameDescription
Visual field defects3 month and annually for 5 years after surgeryTo characterize long-term functional consequences of NFL or macular changes with regards to peripheral and central visual field defects after PPV.
Open-angle glaucoma3 month and annually for 5 years after surgeryTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026