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Assessment of Macular Edema Using HRT Technique

This study is not yet open for participant recruitment.
Verified by McGill University Health Center, February 2008

Sponsored by: McGill University Health Center
Information provided by: McGill University Health Center
ClinicalTrials.gov Identifier: NCT00627718
  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

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Edema    Macular Degeneration   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Single Blind (Outcomes Assessor), Single Group Assignment
Official Title:   Assessment of Macular Edema Using HRT Technique

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  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

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

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

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

Study placed in the following topic categories:
Macular Edema
Eye Diseases
Retinal Degeneration
Edema
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on September 05, 2008




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