Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older (VAST)

March 27, 2018 updated by: Nova Southeastern University

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1584

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Schaeffer Eye Center
      • Birmingham, Alabama, United States, 35294
        • Leo Semes
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Schwartz Laser Eye Center
    • California
      • Sepulveda, California, United States, 91343
        • VA Greater Los Angeles Healthcare System
    • Colorado
      • Broomfield, Colorado, United States, 80023
        • Front Range Eye Associates
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Aran Eye Associates
      • Fort Lauderdale, Florida, United States, 33328
        • Nova Southeastern University
      • Miami, Florida, United States, 33126
        • Retina Macula Specialists of Miami
      • Miami, Florida, United States, 33143
        • Murray Ocular Oncology and Retina
      • Winter Haven, Florida, United States, 33880
        • Vitreous and Retina Consultants
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University College of Optometry
    • Kansas
      • Olathe, Kansas, United States, 66061
        • Grin Eyecare
    • New Mexico
      • Albuquerque, New Mexico, United States, 87111
        • Jones Eyecare
    • Oregon
      • Portland, Oregon, United States, 97205
        • Pacific University College of Optometry
    • Texas
      • McKinney, Texas, United States, 75070
        • Larry Alexander
    • Washington
      • Tacoma, Washington, United States, 98409
        • Retina and Macula Specialists
      • University Place, Washington, United States, 98466
        • Suburban Opticians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be selected from primary eye care clinics within academic settings, tertiary care clinics, and veterans administration medical centers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Vitreomacular adhesion
Male or female subjects aged over 40 years with vitreomacular adhesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

ThromboGenics
Optovue
Carl Zeiss Meditec, Inc.

Investigators

  • Principal Investigator: Julie A Rodman, OD, MS, FAAO, Nova Southeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11221319Exp

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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