Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older

NCT ID: NCT02160340

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1584 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitreomacular Adhesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitreomacular adhesion

Male or female subjects aged over 40 years with vitreomacular adhesion

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clear media

Exclusion Criteria

* Prior history of vitreoretinal surgery or pharmacotherapy with intravitreal injection
* Dense media opacity
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ThromboGenics

INDUSTRY

Sponsor Role collaborator

Carl Zeiss Meditec, Inc.

INDUSTRY

Sponsor Role collaborator

Optovue

INDUSTRY

Sponsor Role collaborator

Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julie A Rodman, OD, MS, FAAO

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Schaeffer Eye Center

Birmingham, Alabama, United States

Site Status

Leo Semes

Birmingham, Alabama, United States

Site Status

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Site Status

VA Greater Los Angeles Healthcare System

Sepulveda, California, United States

Site Status

Front Range Eye Associates

Broomfield, Colorado, United States

Site Status

Aran Eye Associates

Coral Gables, Florida, United States

Site Status

Nova Southeastern University

Fort Lauderdale, Florida, United States

Site Status

Retina Macula Specialists of Miami

Miami, Florida, United States

Site Status

Murray Ocular Oncology and Retina

Miami, Florida, United States

Site Status

Vitreous and Retina Consultants

Winter Haven, Florida, United States

Site Status

Clayton Eye Center

Morrow, Georgia, United States

Site Status

Indiana University College of Optometry

Indianapolis, Indiana, United States

Site Status

Grin Eyecare

Olathe, Kansas, United States

Site Status

Jones Eyecare

Albuquerque, New Mexico, United States

Site Status

Pacific University College of Optometry

Portland, Oregon, United States

Site Status

Larry Alexander

McKinney, Texas, United States

Site Status

Retina and Macula Specialists

Tacoma, Washington, United States

Site Status

Suburban Opticians

University Place, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11221319Exp

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of OCT Measurements
NCT01806402 COMPLETED