Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study

NCT ID: NCT01162356

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2017-01-24

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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 neovascular membrane

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Kim, MD

Associate Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Eye Institute

Maziar Lalezary, MD

Role: STUDY_DIRECTOR

Vanderbilt Eye Institute

Rahul K Reddy, MD

Role: STUDY_DIRECTOR

Vanderbilt Eye Institute

Locations

Vanderbilt Eye Institute

Nashville, Tennessee, United States

Countries

United States

References

Machemer R, Buettner H, Norton EW, Parel JM. Vitrectomy: a pars plana approach. Trans Am Acad Ophthalmol Otolaryngol. 1971 Jul-Aug;75(4):813-20. No abstract available.

Reference Type: BACKGROUND

PMID: 5566980 (View on PubMed)

Chang S. LXII Edward Jackson lecture: open angle glaucoma after vitrectomy. Am J Ophthalmol. 2006 Jun;141(6):1033-1043. doi: 10.1016/j.ajo.2006.02.014.

Reference Type: BACKGROUND

PMID: 16765671 (View on PubMed)

Luk FO, Kwok AK, Lai TY, Lam DS. Presence of crystalline lens as a protective factor for the late development of open angle glaucoma after vitrectomy. Retina. 2009 Feb;29(2):218-24. doi: 10.1097/IAE.0b013e31818ba9ca.

Reference Type: BACKGROUND

PMID: 18936722 (View on PubMed)

Other Identifiers

100073

Identifier Type: -

Identifier Source: org_study_id