Vitreomacular AdhesionVASTNCT02160340
Prevalence of Vitreomacular Adhesion in Patients 40 Years and Older
An observational study of Vitreomacular Adhesion, run by Nova Southeastern University at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitreomacular Adhesion
- How many people
- 1,584 participants
- Where
- 18 sitesUnited States
- Study dates
- May 2014to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be selected from primary eye care clinics within academic settings, tertiary care clinics, and veterans administration medical centers.
Who may be able to join
- Clear media
Who cannot join
- Prior history of vitreoretinal surgery or pharmacotherapy with intravitreal injection
- Dense media opacity
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Jones Eyecare
Albuquerque, New Mexico, 87111
Schaeffer Eye Center
Birmingham, Alabama, 35216
Leo Semes
Birmingham, Alabama, 35294
Front Range Eye Associates
Broomfield, Colorado, 80023
Aran Eye Associates
Coral Gables, Florida, 33134
Nova Southeastern University
Fort Lauderdale, Florida, 33328
Indiana University College of Optometry
Indianapolis, Indiana, 46202
Larry Alexander
McKinney, Texas, 75070
Retina Macula Specialists of Miami
Miami, Florida, 33126
Murray Ocular Oncology and Retina
Miami, Florida, 33143
Clayton Eye Center
Morrow, Georgia, 30260
Grin Eyecare
Olathe, Kansas, 66061
Pacific University College of Optometry
Portland, Oregon, 97205
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
VA Greater Los Angeles Healthcare System
Sepulveda, California, 91343
Retina and Macula Specialists
Tacoma, Washington, 98409
Suburban Opticians
University Place, Washington, 98466
Vitreous and Retina Consultants
Winter Haven, Florida, 33880
About this study
Official title: Phase 1 Study of Optical Coherence Tomography Images to Identify the Prevalence of Vitreomacular Adhesion and Associated Maculopathies
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.
Read the 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.
- Conditions
- Vitreomacular Adhesion
- Keywords
- Posterior Vitreous Detachment, Vitreomacular Traction, Vitreous
- Medical subject headings
- Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitreomacular adhesion | Male or female subjects aged over 40 years with vitreomacular adhesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?
Spectral domain optical coherence tomography scans will be used to evaluate for the presence of isolated or concomitant vitreomacular adhesion.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreomacular AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- ThromboGenics, Carl Zeiss Meditec, Inc., Optovue
- Responsible party
- Sponsor
- Investigators
- Julie A Rodman, OD, MS, FAAO, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160340
- Sponsor's protocol ID
- 11221319Exp
- Acronym
- VAST
- Status last verified
- Mar 2018
- First submitted
- 2 Jun 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Optical Coherence Tomography Images to Identify the Prevalence of Vitreomacular Adhesion and Associated Maculopathies
- ClinicalTrials.gov ID
- NCT02160340
- Acronym / sponsor ID
- VAST / 11221319Exp
- Conditions
- Vitreomacular Adhesion
- Keywords
- Posterior Vitreous Detachment, Vitreomacular Traction, Vitreous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,584 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- ThromboGenics, Carl Zeiss Meditec, Inc., Optovue
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitreomacular adhesion | – | –Male or female subjects aged over 40 years with vitreomacular adhesion |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from primary eye care clinics within academic settings, tertiary care clinics, and veterans administration medical centers.
Key inclusion criteria (1 listed)
- Clear media
Key exclusion criteria (2 listed)
- Prior history of vitreoretinal surgery or pharmacotherapy with intravitreal injection
- Dense media opacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Rodman, OD, MS, FAAO principal investigator
Nova Southeastern University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitreomacular Adhesion, run by Nova Southeastern University at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the overall prevalence of Vitreomacular adhesion in the population 40 years and older? (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.