Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular Edema
NCT ID: NCT00994955
Last Updated: 2013-01-16
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2006-01-31
2009-10-31
Brief Summary
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Detailed Description
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OBJECTIVE: To evaluate effectivity and safety of Selective Retina Therapy (SRT) for diabetic macular edema (DME).
DESIGN: Prospective two-center interventional uncontrolled case series. PARTICIPANTS: 39 eyes of 39 patients with previously untreated non-ischemic DME.
INTERVENTION: Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer. The pulse energy was individually adjusted to achieve angiographically visible but funduscopically invisible effects. Optoacoustic measurements were performed to detect the individual threshold of RPE damage during laser treatment and correlated with funduscopy and fundus fluorescein angiography (FFA) or indocyanine green angiography. Follow-up at 3 and 6 months post treatment included best-corrected ETDRS visual acuity (BCVA), FFA, fundus photography, and retinal thickness measured by optical coherence tomography (OCT).
MAIN OUTCOME MEASURES: Change of BCVA, change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements.
RESULTS: Mean BCVA improved from 43.7 letters (standard deviation, SD=9.1) at baseline to 46.1 letters (SD=10.5) at 6 months follow-up (p=0.02). BCVA improved (\> 5 letters) or remained stable (+/- 5 letters) in 84% of eyes. 13% of eyes improved by ≥ 10 letters while 16% of eyes lost more than 5 letters. There was no severe loss of vision (loss of ≥ 15 letters). Overall, mean central retinal thickness, hard exsudates and leakage in FFA did not change significantly (p\>0.05) while improvement of BCVA correlated with a reduction of hard exsudates and central retinal thickness. Specificity and sensitivity of detecting the angiographic visible threshold of RPE damage by optoacoustic measurements were 86% and 70%, respectively. No adverse effects or pain were noted during or after treatment.
CONCLUSION: SRT is an effective and safe treatment of DME with functional and anatomical improvement or stabilization in most patients. Optoacoustic measurements are suitable to detect the individual threshold of RPE damage.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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selective retina therapy (SRT)
Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer.
selective retina therapy (SRT)
laser treatment
Interventions
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selective retina therapy (SRT)
laser treatment
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Medical Laser Center Lübeck, Germany
UNKNOWN
St Thomas
AMBIG
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Jost Hillenkamp
Oberarzt, Dept. of Ophthalmology, University of Schleswig-Holstein, Kiel, Germany
Principal Investigators
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Jost Hillenkamp, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Ophthalmology, University Medical Center Schleswig-Holstein, Kiel Campus
Other Identifiers
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SRT-1
Identifier Type: -
Identifier Source: org_study_id
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