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Completed

NCT Number: NCT02160340

Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older

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.

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Key information

Conditions

Vitreomacular Adhesion Eye Diseases Vitreous Detachment

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leo Semes, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. What is the overall prevalence of Vitreomacular adhesion in the population 40 years and older?

    Time frame: Two years

    Prevalence will be measured using Spectral Domain Optical Coherence Tomography. Tomography scans will be evaluated for the presence or absence of vitreomacular adhesion.

Secondary outcomes

  1. 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

    Spectral domain optical coherence tomography scans will be used to evaluate for the presence of isolated or concomitant vitreomacular adhesion.

Other outcomes

  1. Is VMA more common in males or females?

    Time frame: 2 years

    The prevalence of VMA in both genders will be identified using Spectral Domain Optical Coherence Tomography and evaluated for statistical significance.

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • Carl Zeiss Meditec, Inc.
  • Optovue
  • ThromboGenics

Registry information

Official study title

Phase 1 Study of Optical Coherence Tomography Images to Identify the Prevalence of Vitreomacular Adhesion and Associated Maculopathies

Acronym: VAST

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 10, 2014
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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