Selective RPE Laser Treatment (SRT) for Various Macular Diseases

NCT00403884 | Unknown

• 1 other identifier: University Eye Hospital SRT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Macular Degeneration; Diabetic Maculopathy; Central Serous Chorioretinopathy

Keywords

Drusen; Geographic atrophy; diabetes; macular edema; laser; retinal pigment epithelium

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  up to 2 years

Secondary Outcomes (3)

• drusen reduction

  up to 2 years

• area of geographic atrophy

  up to 2 years

• reduction of retinal edema

  up to 2 years

Interventions

Selective RPE laser treatment PROCEDURE

interventional SRT laser treatment

Also known as: SRT vario, Medical Laser Center, Luebeck, Germany

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous laser treatment
• previous intravitreal injections
• choroidal neovascularization
• visual acuity \> 0.1

Sponsors & Collaborators

• University of Regensburg: lead
• Dr. Werner Jackstaedt Foundation: collaborator

Study Sites (1)

University Eye Hospital Regensburg

Regensburg, 93042, Germany

Location

MeSH Terms

Conditions

Macular Degeneration; Central Serous Chorioretinopathy; Geographic Atrophy; Diabetes Mellitus; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Carsten Framme, MD

  University Eye Hospital Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2006
• First Posted: November 27, 2006
• Study Start: October 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: August 1, 2010
• Last Updated: January 13, 2010

Record last verified: 2006-11

Locations

DE (1)