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Selective RPE Laser Treatment (SRT) for Various Macular Diseases

This study is currently recruiting participants.
Verified by University of Regensburg, November 2006

Sponsored by: University of Regensburg
Information provided by: University of Regensburg
ClinicalTrials.gov Identifier: NCT00403884
  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

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Edema    Macular Degeneration   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Selective RPE Laser Treatment (SRT) for Various Macular Diseases

Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Visual acuity

Secondary Outcome Measures:
  • drusen reduction
  • area of geographic atrophy
  • reduction of retinal edema

Estimated Enrollment:   60
Study Start Date:   October 2004
Estimated Study Completion Date:   November 2006

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403884

Contacts
Contact: Carsten Framme, MD     0049 941 944 9194     carsten.framme@klinik.uni-regensburg.de    

Locations
Germany
University Eye Hospital Regensburg     Recruiting
      Regensburg, Germany, 93042
      Principal Investigator: Carsten Framme, MD            
      Sub-Investigator: Andreas Walter, MD            
      Sub-Investigator: Philipp Prahs, MD            

Sponsors and Collaborators
University of Regensburg

Investigators
Principal Investigator:     Carsten Framme, MD     University Eye Hospital Regensburg    
  More Information


Study ID Numbers:   University Eye Hospital SRT
First Received:   November 24, 2006
Last Updated:   November 24, 2006
ClinicalTrials.gov Identifier:   NCT00403884
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Macular Edema
Eye Diseases
Diabetes Mellitus
Retinal Degeneration
Edema
Macular Degeneration
Atrophy
Central serous chorioretinopathy
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on October 03, 2008




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