This trial is active, not recruiting.

Condition vitreomacular adhesion
Sponsor Nova Southeastern University
Collaborator ThromboGenics
Start date May 2014
End date January 2016
Trial size 1584 participants
Trial identifier NCT02160340, 11221319Exp


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Male or female subjects aged over 40 years with vitreomacular adhesion

Primary Outcomes

What is the overall prevalence of Vitreomacular adhesion in the population 40 years and older?
time frame: Two years

Secondary Outcomes

Is there is a significant correlation between VMA and various maculopathies including diabetic macular edema, retinal vascular occlusion, and age-related macular degeneration?
time frame: 2 years

Eligibility Criteria

All participants at least 40 years old.

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

Additional Information

Official title Phase 1 Study of Optical Coherence Tomography Images to Identify the Prevalence of Vitreomacular Adhesion and Associated Maculopathies
Principal investigator Julie A Rodman, OD, MS, FAAO
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Nova Southeastern University.