Assessment of Macular Edema Using HRT Technique

NCT00627718 | Unknown

• 1 other identifier: BMB 06-029
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Keywords

Age-related macular degeneration; HRT; Macular edema; Screening for disease

Outcome Measures

Primary Outcomes (1)

• Positive predictive value of screening test

  1 year

Study Arms (1)

A

OTHER

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

Interventions

HRT screening for macula edema DEVICE

HRT screening for macula edema at time of initial diagnosis of macular degeneration

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant media opacity
• Other causes of macular edema (ME) (diabetes, vascular occlusions)
• Diabetic patients with retinopathy

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

MUHC

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Macular Degeneration; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Mila Oh, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 3, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 3, 2008

Record last verified: 2008-02

Locations

CA (1)