Clinical trial NCT01162356: Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study
Official title: A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Macular Pucker
Macula Hole
Vitreomacular Traction
Vitreous Opacities or Hemorrhage
Keywords: Vitrectomy
Glaucoma
Macula
Optic nerve
Ocular Coherence Tomography
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting to ophthalmology practice requiring pars plana vitrectomy

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.


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

Primary outcomes:
measure: Nerve fiber layer and macular changes after vitrectomy
timeFrame: 3 month and annually for 5 years after surgery
Secondary outcomes:
measure: Visual field defects
timeFrame: 3 month and annually for 5 years after surgery
measure: Open-angle glaucoma
timeFrame: 3 month and annually for 5 years after surgery
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
Study officials:
affiliation: Vanderbilt Eye Institute
name: Stephen J Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Eye Institute
name: Maziar Lalezary, MD
role: STUDY_DIRECTOR
affiliation: Vanderbilt Eye Institute
name: Rahul K Reddy, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.