View Clinical Trial (Medical Research Study)
A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37203 |
| Conditions: |
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Glaucoma - Macular Pucker - Macula Hole - Vitreomacular Traction - Vitreous Opacities or Hemorrhage |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01162356 |
| Primary Contact: |
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Principal Investigator
Stephen J Kim, MD
Vanderbilt Eye Institute
Maziar Lalezary, MD
Phone: 615-266-6299
Email: m.lalezary@vanderbilt.edu
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| Backup Contact: |
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Email: stephen.j.kim@vanderbilt.edu
Stephen J Kim, MD
Phone: 615-936-2020
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| Location Contact: |
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Nashville, Tennessee 37203
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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