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Assessment of Macular Edema Using HRT Technique

Primary Purpose

Age-Related Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HRT screening for macula edema
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age-Related Macular Degeneration focused on measuring Age-related macular degeneration, HRT, Macular edema, Screening for disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • MUHC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A

Arm Description

All patients with possible neovascular ARMD are assessed with HRT to determined the positive predictive value of the test

Outcomes

Primary Outcome Measures

Positive predictive value of screening test

Secondary Outcome Measures

Full Information

First Posted
February 22, 2008
Last Updated
February 29, 2008
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00627718
Brief Title
Assessment of Macular Edema Using HRT Technique
Official Title
Assessment of Macular Edema Using HRT Technique
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Introduction: Age-related macular degeneration (ARMD) is a spectrum of related diseases that affects the macula and it has been traditionally classified into early and late stages with its dry (non-exudative) and wet (exudative) forms. Although the advanced form of AMD is less common, the potential visual loss is more significant. The Beaver Dam Eye Study reported that 30% of individuals aged 75 and older have some form of AMD, whereas 7% of those aged 75 and older have an advanced form. Recent studies estimate that 8 million Americans are considered to be at risk for developing advanced ARMD in the next 5 years, whereas 1.75 million are currently affected with the advanced form of the disease. Wet AMD is characterized by proliferation of abnormal vessels in the choroid. These choroidal neovascular membranes may proliferate into the subretinal space and retina and leak fluid and blood. This fluid may accumulate in the macula area causing macular edema (ME), the final common pathway for visual loss in many diseases. There are currently no treatments that can reverse or repair the destruction and restore visual acuity. The critical time for any intervention is early in the disease, when visual acuity has been minimally affected. Due to the irreversible nature of the disease and a realistic risk of permanent vision loss, there is an increased need to improve the accuracy of identifying the presence and extent of MEvwith a prompt referral to a retina specialist following diagnosis. ME has traditionally been assessed clinically using a combination of slit lamp biomicroscopy and fluorescein angiography. New imaging techniques such as optical coherence tomography (OCT), the retinal thickness analyser (RTA), and the Heidelberg retinal tomograph (HRT) confocal scanning laser ophthalmoscope facilitate qualitative assessments of the degree of ME. Although OCT has a high sensitivity and specificity for the detection of ME within 500 microns of the fovea, this resolution decreases outside this area. RTA has shown lower sensitivity (57%) for the detection of ME. 4 The Heidelberg Retinal Tomograph II (HRT II, Heidelberg Engineering) is a non-invasive, confocal scanning laser imaging system that uses a red (670 nm) diode laser to perform a series of optical sections of the macula area covering a 15°x15° field of view, corresponding to approximately 4.5 x 4.5 mm on the retina. The reflected laser light intensity is processed assisting with a quantitative diagnosis of ME. If ME is present, the amount of scatter inside the swollen retina increases, reducing retinal reflectance. A few studies have evaluated the HRT for detecting ME. Tong and co-workers have proposed a scoring system for macular image assessment using HRT in patients with diabetic maculopathy. Guan and co-workers found the HRT to have a sensitivity and specificity of 92% and 68% for detecting ME in the diabetic population when using clinical assessment as the gold standard. To the best of our knowledge, no studies have yet validate the used HRT for the detection of ME as an early sign of exudative disease in ARMD patients. Purpose: The purpose of the study is to assessed the sensitivity, specificity, and repeatability, of HRT for the presence of ME in exudative ARMD Design: Prospective, observational study. Objectives: 1) Assessment of healthy volunteers to obtain baseline normal measurements of macular thickening. 2) Measurements in ARMD patient's referred to a retinal specialist clinic with the diagnosis of exudative form of ARMD Patients, Material, and Methods: 1) normal controls (N=20): baseline measurements centered at the fovea will be taken. Three consecutive measurements will be performed (within-session repeatability). 2) Patients: New patients referred by general ophthalmologists to the retina specialist for possible diagnosis of ARMD, exudative formed, will be included in the study. All patients will undergo a full ophthalmologic exam by the same retinal specialist who will determine the clinical presence of ME (gold standard) using fundus contact lens examination. In some cases, fluorescein angiograms will be use as an ancillary test. All patients will then be evaluated using HRT for the presence of ME using the macula edema module. The technician performing the test will be mask to the patients' clinical diagnosis. Three consecutive measurements will be performed in 4 quadrants (500-1000-1500 microns/ 4 quadrants) (color map and reflectivity) 3) Comparison will be made between the clinical diagnosis of ME (gold standard) and results obtained by the HRT. Features compared: 1) presence/absence of ME 2) spacial agreement between areas of elevated retina encountered by HRT Vs clinical examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Age-related macular degeneration, HRT, Macular edema, Screening for disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
All patients with possible neovascular ARMD are assessed with HRT to determined the positive predictive value of the test
Intervention Type
Device
Intervention Name(s)
HRT screening for macula edema
Intervention Description
HRT screening for macula edema at time of initial diagnosis of macular degeneration
Primary Outcome Measure Information:
Title
Positive predictive value of screening test
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mila Oh, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mila Oh, MDCM, FRCSC
Phone
(514) 843-1646
Email
milaoh@videotron.ca
First Name & Middle Initial & Last Name & Degree
Mila Oh, MDCM, FRCSC

12. IPD Sharing Statement

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Assessment of Macular Edema Using HRT Technique

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