Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study

NCT01162356 | Completed

• 1 other identifier: 100073
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Nerve fiber layer and macular changes after vitrectomy

  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.

  3 month and annually for 5 years after surgery

Secondary Outcomes (2)

• Visual field defects

  3 month and annually for 5 years after surgery

• Open-angle glaucoma

  3 month and annually for 5 years after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to ophthalmology practice requiring pars plana vitrectomy

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt Eye Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (3)

• 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.

  PMID: 5566980 BACKGROUND

• 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.

  PMID: 16765671 BACKGROUND

• 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.

  PMID: 18936722 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Epiretinal Membrane; Retinal Perforations; vitreous floaters; Hemorrhage

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Retinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen J Kim, MD

  Vanderbilt Eye Institute

  PRINCIPAL INVESTIGATOR

• Maziar Lalezary, MD

  Vanderbilt Eye Institute

  STUDY DIRECTOR

• Rahul K Reddy, MD

  Vanderbilt Eye Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 14, 2010
• Study Start: July 1, 2010
• Primary Completion: January 24, 2017
• Study Completion: January 24, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)