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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02160340
Other study ID # 11221319Exp
Secondary ID
Status Completed
Phase
First received June 2, 2014
Last updated March 27, 2018
Start date May 2014
Est. completion date May 2017

Study information

Verified date March 2018
Source Nova Southeastern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the prevalence of vitreomacular adhesion (VMA) in patients 40 years and older using Spectral Domain Optical Coherence Tomography.


Description:

As a function of age, liquefaction of the vitreous body results in separation of the vitreous cavity from the retina. This posterior vitreous separation may be incomplete, leading to areas of residual VMA. These adhesions can result in maculopathies such as vitreomacular traction syndrome, macular hole, epiretinal membrane, cystoid macular edema, diabetic macular edema, neovascularization in diabetic retinopathy and retinal vein occlusion, exudative age-related macular degeneration, and myopic traction maculopathy. VMA may lead to pathological sequelae due to the static and dynamic anteroposterior tractional forces to the surface of the macula. The resultant complication will depend on the size and strength of the traction, with smaller areas of adhesion leading to greater traction. Identifying the prevalence of vitreomacular adhesion and its associated complications will yield valuable, new epidemiologic data, leading to improved diagnosis and management of patients with this condition. The prevalence of vitreomacular adhesion in specific age groups has not been investigated.


Recruitment information / eligibility

Status Completed
Enrollment 1584
Est. completion date May 2017
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: 40 years and older

- Clear media

Exclusion Criteria: Less than 40 years of age

- Prior history of vitreoretinal surgery or pharmacotherapy with intravitreal injection

- Dense media opacity

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Jones Eyecare Albuquerque New Mexico
United States Leo Semes Birmingham Alabama
United States Schaeffer Eye Center Birmingham Alabama
United States Front Range Eye Associates Broomfield Colorado
United States Aran Eye Associates Coral Gables Florida
United States Nova Southeastern University Fort Lauderdale Florida
United States Indiana University College of Optometry Indianapolis Indiana
United States Larry Alexander McKinney Texas
United States Murray Ocular Oncology and Retina Miami Florida
United States Retina Macula Specialists of Miami Miami Florida
United States Clayton Eye Center Morrow Georgia
United States Grin Eyecare Olathe Kansas
United States Pacific University College of Optometry Portland Oregon
United States Schwartz Laser Eye Center Scottsdale Arizona
United States VA Greater Los Angeles Healthcare System Sepulveda California
United States Retina and Macula Specialists Tacoma Washington
United States Suburban Opticians University Place Washington
United States Vitreous and Retina Consultants Winter Haven Florida

Sponsors (4)

Lead Sponsor Collaborator
Nova Southeastern University Carl Zeiss Meditec, Inc., Optovue, ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Is VMA more common in males or females? The prevalence of VMA in both genders will be identified using Spectral Domain Optical Coherence Tomography and evaluated for statistical significance. 2 years
Primary What is the overall prevalence of Vitreomacular adhesion in the population 40 years and older? Prevalence will be measured using Spectral Domain Optical Coherence Tomography. Tomography scans will be evaluated for the presence or absence of vitreomacular adhesion. Two years
Secondary Is there is a significant correlation between VMA and various maculopathies including diabetic macular edema, retinal vascular occlusion, and age-related macular degeneration? Spectral domain optical coherence tomography scans will be used to evaluate for the presence of isolated or concomitant vitreomacular adhesion. 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01966328 - A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment Phase 1
Withdrawn NCT02001701 - Intravitreal Gas for Vitreomacular Adhesion N/A
Completed NCT02322229 - Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion Phase 4
Completed NCT00798317 - Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial. Phase 3
Completed NCT00781859 - Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial. Phase 3
Completed NCT02035748 - Assessment of Patients Treated With JETREA® for Vitreomacular Traction Phase 4