Assessment of Macular Edema Using HRT Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627718
Recruitment Status : Unknown
Verified February 2008 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2008
Last Update Posted : March 3, 2008
Information provided by:
McGill University Health Center

Brief Summary:

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 or disease Intervention/treatment Phase
Age-Related Macular Degeneration Device: HRT screening for macula edema Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Assessment of Macular Edema Using HRT Technique
Study Start Date : April 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Positive predictive value of screening test [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627718

Canada, Quebec
MUHC Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Mila Oh, MDCM, FRCSC    (514) 843-1646   
Principal Investigator: Mila Oh, MDCM, FRCSC         
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Mila Oh, MD McGill University Health Center

Responsible Party: Mila Oh, MD, MUHC Identifier: NCT00627718     History of Changes
Other Study ID Numbers: BMB 06-029
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: February 2008

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

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases