Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study

This study is currently recruiting participants.
Verified December 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Stephen J. Kim, MD, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01162356
First received: July 12, 2010
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult patients presenting to ophthalmology practice requiring pars plana vitrectomy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162356

Contacts
Contact: Maziar Lalezary, MD 615-266-6299 m.lalezary@vanderbilt.edu
Contact: Stephen J Kim, MD 615-936-2020 stephen.j.kim@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt Eye Institute Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Stephen J Kim, MD         
Sub-Investigator: Maziar Lalezary, MD         
Sub-Investigator: Rahul K Reddy, MD         
Sub-Investigator: Franco M Recchia, MD         
Sub-Investigator: Janice C Law, MD         
Sub-Investigator: Anita Agarwal, MD         
Sub-Investigator: Jeffery A Kammer, MD         
Sub-Investigator: Rachel Kuchtey, MD         
Sub-Investigator: Karen Joos, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
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
  More Information

Publications:
Responsible Party: Stephen J. Kim, MD, Associate Professor of Ophthalmology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01162356     History of Changes
Other Study ID Numbers: 100073
Study First Received: July 12, 2010
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Vitrectomy
Glaucoma
Macula
Optic nerve
OCT

Additional relevant MeSH terms:
Glaucoma
Hemorrhage
Retinal Diseases
Ocular Hypertension
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014