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Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)

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ClinicalTrials.gov Identifier: NCT00000167
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:
National Eye Institute (NEI)

Brief Summary:
To determine whether application of low-intensity laser treatment of eyes with drusen in the macula can prevent later complications of age-related macular degeneration and thereby preserve visual function.

Condition or disease Intervention/treatment Phase
Macular Degeneration Procedure: Low-Intensity Laser Treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1052 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
Study Start Date : May 1999
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Laser treatment
Procedure: Low-Intensity Laser Treatment
Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.



Primary Outcome Measures :
  1. Change in visual acuity (3-line loss) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy [ Time Frame: 5 years ]
  2. Changes in contrast threshold and critical print size for reading [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients eligible for CAPT can be either male or female and meet the following criteria:

Age at least 50 years old

Vision in each eye must measure 20/40 or better.

At least 10 large drusen in each eye

Available for follow-up examinations for 5 years after enrollment

Final eligibility is determined through a detailed eye examination by a CAPT-certified ophthalmologist.


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 ClinicalTrials.gov identifier (NCT number): NCT00000167


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Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Study Chair: Stuart L Fine, MD Scheie Eye Institute, The University of Pennsylvania School of Medicine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Natalie Kurinij, NEI
ClinicalTrials.gov Identifier: NCT00000167     History of Changes
Other Study ID Numbers: NEI-70
First Posted: September 24, 1999    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: December 2007

Keywords provided by National Eye Institute (NEI):
Age-Related Macular Degeneration

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