NCT02160340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

June 2, 2014

Last Update Submit

March 27, 2018

Conditions

Keywords

Posterior Vitreous DetachmentVitreomacular TractionVitreous

Outcome Measures

Primary Outcomes (1)

  • 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 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?

    2 years

Other Outcomes (1)

  • Is VMA more common in males or females?

    2 years

Study Arms (1)

Vitreomacular adhesion

Male or female subjects aged over 40 years with vitreomacular adhesion

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Clear media

You may not qualify if:

  • Prior history of vitreoretinal surgery or pharmacotherapy with intravitreal injection
  • Dense media opacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Schaeffer Eye Center

Birmingham, Alabama, 35216, United States

Location

Leo Semes

Birmingham, Alabama, 35294, United States

Location

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

VA Greater Los Angeles Healthcare System

Sepulveda, California, 91343, United States

Location

Front Range Eye Associates

Broomfield, Colorado, 80023, United States

Location

Aran Eye Associates

Coral Gables, Florida, 33134, United States

Location

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

Retina Macula Specialists of Miami

Miami, Florida, 33126, United States

Location

Murray Ocular Oncology and Retina

Miami, Florida, 33143, United States

Location

Vitreous and Retina Consultants

Winter Haven, Florida, 33880, United States

Location

Clayton Eye Center

Morrow, Georgia, 30260, United States

Location

Indiana University College of Optometry

Indianapolis, Indiana, 46202, United States

Location

Grin Eyecare

Olathe, Kansas, 66061, United States

Location

Jones Eyecare

Albuquerque, New Mexico, 87111, United States

Location

Pacific University College of Optometry

Portland, Oregon, 97205, United States

Location

Larry Alexander

McKinney, Texas, 75070, United States

Location

Retina and Macula Specialists

Tacoma, Washington, 98409, United States

Location

Suburban Opticians

University Place, Washington, 98466, United States

Location

MeSH Terms

Conditions

Vitreous Detachment

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Julie A Rodman, OD, MS, FAAO

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 10, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

May 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations