Assessment of Macular Edema Using HRT Technique

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by McGill University Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00627718
First received: February 22, 2008
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

Age Related Macular Degeneration (ARMD) is the most common cause of irreversible blindness in people of age 50 or older in the western populations. ARMD has two forms, the wet and the dry forms. The wet form is more serious and can lead to irreversible loss of vision. In the wet form of ARMD, new blood vessels grow under the retina. These blood vessels leak blood and fluid and cause the retina and the macula to swell. So the thickness of the macula increases.

One of the key factors in the treatment of wet ARMD is early diagnosis and treatment to prevent complete visual loss. In this research, we are going to use a technique, called the Heidelberg retinal tomograph (HRT) to measure and compare the thickness of the macula in healthy controls and in patients suspected of having ARMD. HRT is a non-invasive imaging system that uses laser to measure the thickness of the macula. This allows us to come up with a quite simple and easy-to-use technique that helps us to diagnose wet ARMD early and treat it before visual acuity is completely lost.


Condition Intervention
Age-Related Macular Degeneration
Device: HRT screening for macula edema

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Assessment of Macular Edema Using HRT Technique

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Positive predictive value of screening test [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
All patients with possible neovascular ARMD are assessed with HRT to determined the positive predictive value of the test
Device: HRT screening for macula edema
HRT screening for macula edema at time of initial diagnosis of macular degeneration

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • New patients referred by general ophthalmologists to the retina specialist for possible diagnosis of ARMD, exudative formed, will be included in the study.

Exclusion Criteria:

  • Significant media opacity
  • Other causes of macular edema (ME) (diabetes, vascular occlusions)
  • Diabetic patients with retinopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627718

Locations
Canada, Quebec
MUHC Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Mila Oh, MDCM, FRCSC    (514) 843-1646    milaoh@videotron.ca   
Principal Investigator: Mila Oh, MDCM, FRCSC         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Mila Oh, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Mila Oh, MD, MUHC
ClinicalTrials.gov Identifier: NCT00627718     History of Changes
Other Study ID Numbers: BMB 06-029
Study First Received: February 22, 2008
Last Updated: February 29, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Age-related macular degeneration
HRT
Macular edema
Screening for disease

Additional relevant MeSH terms:
Edema
Macular Degeneration
Macular Edema
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014