Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older

Vitreomacular Adhesion Clinical Trial

— VAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160340
• Other study ID #: 11221319Exp
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Tissue Adhesions
• Vitreomacular Adhesion

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