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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY014231 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Eye Institute (NEI) | NIH |
| Juvenile Diabetes Research Foundation | OTHER |
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Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Vitrectomy | Active Comparator |
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| Deferred Vitrectomy | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Vitrectomy | Procedure | Surgery to remove epiretinal membrane (ERM). Vitrectomy will be performed on eyes within 1 month of randomization |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in visual acuity letter score from baseline to 36 months | Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart. | Baseline to 36 months |
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Key Inclusion Criteria:
Age ≥ 45 years
E-ETDRS visual acuity 20/40 or better (≥69 letters)
o ERM must be thought to be the primary cause of vision loss
ERM meeting the following criteria, according to the investigator
Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 weeks to see if vision remains stable without having to proceed to vitrectomy)
No known medical problems that will be a contraindication to surgery
Key Exclusion Criteria:
History of retinal vascular disease
History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM
o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion
History of inflammatory disease unless mild and completely resolved at least one year prior to randomization
History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis (except mild uveitis that resolved >1 year prior to randomization)
Prior intraocular surgery (except uncomplicated cataract extraction)
Cataract extraction within prior 3 months
Laser or cryosurgical retinopexy within one month of randomization
Pneumatic retinopexy within one year of randomization
Current untreated retinal tear or detachment
o A previously treated retinal tear with up to one disc diameter radius of subretinal fluid is permitted
Macular hole
Degenerative lamellar macular hole
o ERM foveoschisis ("tractional" lamellar hole) is permitted
Vitreomacular traction within 1,500 microns of foveal center
Central serous chorioretinopathy
Nonproliferative diabetic retinopathy or worse (DR severity >20)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Deferred Vitrectomy | Procedure | Vitrectomy may be performed only if at least one of the following criteria is met:
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| Kent W. Small, MD, AMC | Recruiting | Glendale | California | 91203-1971 | United States |
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| Salehi Retina Institute Inc. | Recruiting | Huntington Beach | California | 92647-8693 | United States |
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| Loma Linda University | Recruiting | Loma Linda | California | 92354 | United States |
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| Retina Vitreous Associates, Northern California Retina Vitreous Assoc Medical Group, Inc. | Recruiting | Mountain View | California | 94040-4123 | United States |
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| East Bay Retina Consultants, Inc. | Recruiting | Oakland | California | 94609-3028 | United States |
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| Regents of the University of California, Davis, DBA University of California, Davis | Recruiting | Sacramento | California | 95817 | United States |
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| Macula Retina Vitreous Institute | Recruiting | Torrance | California | 90503 | United States |
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| Florida Retina Institute, James A. Staman, MD, PA- Jacksonville | Recruiting | Jacksonville | Florida | 32216 | United States |
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| Sarasota Retina Institute | Recruiting | Sarasota | Florida | 34239 | United States |
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| SEASHORE RETINA LLC DBA Retina Specialists of Tampa | Recruiting | Wesley Chapel | Florida | 33544 | United States |
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| Southeast Retina Center, P.C. | Recruiting | Augusta | Georgia | 30909 | United States |
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| Thomas Eye Group | Recruiting | Sandy Springs | Georgia | 30328 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Illinois Retina Associates SC - Oak Park Site | Recruiting | Oak Park | Illinois | 60304 | United States |
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| Raj K. Maturi, M.D., P.C. | Recruiting | Indianapolis | Indiana | 46290 | United States |
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| Mid-America Retina Consultants, P.A. | Recruiting | Overland Park | Kansas | 66211 | United States |
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| University of Kansas Medical Center Research Institute, Inc. | Recruiting | Prairie Village | Kansas | 66208 | United States |
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| Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana | Recruiting | West Monroe | Louisiana | 71291-4452 | United States |
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| Elman Retina Group, P.A. | Recruiting | Baltimore | Maryland | 21237 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Valley Eye Physicians and Surgeons | Recruiting | Ayer | Massachusetts | 01432 | United States |
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| Joslin Diabetes Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Retina Associates of Michigan | Recruiting | Grand Blanc | Michigan | 48439 | United States |
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| The Curators of the University of Missouri | Recruiting | Columbia | Missouri | 65201-5276 | United States |
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| Retina Research Institute, LLC | Recruiting | St Louis | Missouri | 63128-1729 | United States |
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| Retina-Vitreous Surgeons of Central NY, PC | Recruiting | Liverpool | New York | 13088 | United States |
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| Retina Associates of Western NY, P.C. | Recruiting | Rochester | New York | 14620-4655 | United States |
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| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27517 | United States |
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| Retina Vitreous Center | Recruiting | Edmond | Oklahoma | 73013-9791 | United States |
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| Verum Research LLC | Recruiting | Eugene | Oregon | 97401 | United States |
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| Cascade Medical Research Institute, LLC | Recruiting | Springfield | Oregon | 97477 | United States |
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| Retina-Vitreous Consultants, Inc. | Recruiting | Monroeville | Pennsylvania | 15146 | United States |
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| The Trustees of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Pittsburg Clinical Trial Consortium | Recruiting | Sewickley | Pennsylvania | 15143 | United States |
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| Hilton Head Retina Institute | Recruiting | Hilton Head Island | South Carolina | 29926 | United States |
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| Ophthalmology Ltd. | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
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| Vanderbilt Eye Institute | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Austin Research Center for Retina | Recruiting | Austin | Texas | 78705 | United States |
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| Retina Consultants of Texas | Recruiting | Bellaire | Texas | 77401 | United States |
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| Baylor College of Medicine, Baylor Eye Physicians and Surgeons | Recruiting | Houston | Texas | 77030 | United States |
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| Texas Retina Associates | Recruiting | Lubbock | Texas | 79424 | United States |
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| Retinal Consultants of San Antonio | Recruiting | San Antonio | Texas | 78240 | United States |
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| The Retina Group of Washington | Recruiting | Reston | Virginia | 20190 | United States |
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| Spokane Eye Clinical Research, PLLC | Recruiting | Spokane | Washington | 99204 | United States |
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| South Tyneside and Sunderland NHS Trust | Recruiting | Sunderland | Tyne and Wear | SR29HP | United Kingdom |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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