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Selective RPE Laser Treatment (SRT) for Various Macular Diseases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by University of Regensburg.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403884
First Posted: November 27, 2006
Last Update Posted: January 13, 2010
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.
Collaborator:
Dr. Werner Jackstaedt Foundation
Information provided by:
University of Regensburg
  Purpose

In this prospective clinical study SRT is performed with various pulse durations at 1.7µs and additionally 200ns to evaluate the different clinical effects of both laser regimens. The macular diseases to be treated are drusen maculopathy and geographic atrophy due to age-related macular degeneration as well as diabetic macular edema and central serous chorioretinopathy.

The beneficial effect in laser treatment is thought to be associated with the restoration of a new barrier of retinal pigment epithelium cells. If this theory is true, the destruction of the photoreceptors causing visual field defects would be only an unwanted and unnecessary side effect. Thus, SRT is able to avoid these unintentional side effects and to achieve the benefit by just treating the RPE.

In this study the clinical effect of SRT for these diseases is evaluated on a long-term basis.


Condition Intervention
Age-Related Macular Degeneration Diabetic Maculopathy Central Serous Chorioretinopathy Procedure: Selective RPE laser treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Selective RPE Laser Treatment (SRT) for Various Macular Diseases

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: up to 2 years ]

Secondary Outcome Measures:
  • drusen reduction [ Time Frame: up to 2 years ]
  • area of geographic atrophy [ Time Frame: up to 2 years ]
  • reduction of retinal edema [ Time Frame: up to 2 years ]

Estimated Enrollment: 60
Study Start Date: October 2004
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Selective RPE laser treatment
    interventional SRT laser treatment
    Other Name: SRT vario, Medical Laser Center, Luebeck, Germany
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symmetric drusen maculopathy with soft drusen both eyes
  • symmetric geographic atrophy both eyes
  • diabetic macular edema single eye
  • acute or chronic central serous chorioretinopathy

Exclusion Criteria:

  • previous laser treatment
  • previous intravitreal injections
  • choroidal neovascularization
  • visual acuity > 0.1
  Contacts and Locations
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): NCT00403884


Locations
Germany
University Eye Hospital Regensburg
Regensburg, Germany, 93042
Sponsors and Collaborators
University of Regensburg
Dr. Werner Jackstaedt Foundation
Investigators
Principal Investigator: Carsten Framme, MD University Eye Hospital Regensburg
  More Information

Responsible Party: PD Dr. med. Carsten Framme, FEBO, MHM, University Eye Hospital Regensburg
ClinicalTrials.gov Identifier: NCT00403884     History of Changes
Other Study ID Numbers: University Eye Hospital SRT
First Submitted: November 24, 2006
First Posted: November 27, 2006
Last Update Posted: January 13, 2010
Last Verified: November 2006

Keywords provided by University of Regensburg:
Drusen
Geographic atrophy
diabetes
macular edema
laser
retinal pigment epithelium

Additional relevant MeSH terms:
Macular Degeneration
Central Serous Chorioretinopathy
Retinal Degeneration
Retinal Diseases
Eye Diseases