Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02160340
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
ThromboGenics
Carl Zeiss Meditec, Inc.
Optovue
Information provided by (Responsible Party):
Nova Southeastern University

Brief 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.

Condition or disease
Vitreomacular Adhesion

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1584 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 1 Study of Optical Coherence Tomography Images to Identify the Prevalence of Vitreomacular Adhesion and Associated Maculopathies
Study Start Date : May 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160340


Locations
Show Show 18 study locations
Sponsors and Collaborators
Nova Southeastern University
ThromboGenics
Carl Zeiss Meditec, Inc.
Optovue
Investigators
Layout table for investigator information
Principal Investigator: Julie A Rodman, OD, MS, FAAO Nova Southeastern University
Layout table for additonal information
Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02160340    
Other Study ID Numbers: 11221319Exp
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by Nova Southeastern University:
Posterior Vitreous Detachment
Vitreomacular Traction
Vitreous
Additional relevant MeSH terms:
Layout table for MeSH terms
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes