Clinical trial NCT02160340: Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older
Official title: Phase 1 Study of Optical Coherence Tomography Images to Identify the Prevalence of Vitreomacular Adhesion and Associated Maculopathies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitreomacular Adhesion
Keywords: Posterior Vitreous Detachment
Vitreomacular Traction
Vitreous
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: ThromboGenics
name: Carl Zeiss Meditec, Inc.
name: Optovue
First posted: 2014-06-10
Enrollment: 1584
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: What is the overall prevalence of Vitreomacular adhesion in the population 40 years and older?
timeFrame: Two years
Secondary outcomes:
measure: Is there is a significant correlation between VMA and various maculopathies including diabetic macular edema, retinal vascular occlusion, and age-related macular degeneration?
timeFrame: 2 years
Other outcomes:
measure: Is VMA more common in males or females?
timeFrame: 2 years
Locations:
city: Birmingham
country: United States
facility: Schaeffer Eye Center
state: Alabama
city: Birmingham
country: United States
facility: Leo Semes
state: Alabama
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Broomfield
country: United States
facility: Front Range Eye Associates
state: Colorado
city: Coral Gables
country: United States
facility: Aran Eye Associates
state: Florida
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
city: Miami
country: United States
facility: Retina Macula Specialists of Miami
state: Florida
city: Miami
country: United States
facility: Murray Ocular Oncology and Retina
state: Florida
city: Winter Haven
country: United States
facility: Vitreous and Retina Consultants
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University College of Optometry
state: Indiana
city: Olathe
country: United States
facility: Grin Eyecare
state: Kansas
city: Albuquerque
country: United States
facility: Jones Eyecare
state: New Mexico
city: Portland
country: United States
facility: Pacific University College of Optometry
state: Oregon
city: McKinney
country: United States
facility: Larry Alexander
state: Texas
city: Tacoma
country: United States
facility: Retina and Macula Specialists
state: Washington
city: University Place
country: United States
facility: Suburban Opticians
state: Washington
Study officials:
affiliation: Nova Southeastern University
name: Julie A Rodman, OD, MS, FAAO
role: PRINCIPAL_INVESTIGATOR
References: