Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Primary Endpoint
- best-corrected visual acuity
Study Overview
Brief Summary
Selective Retina Therapy (SRT) is an effective and safe laser treatment of clinically significant diabetic macular edema which targets the retinal pigment epithelium while sparing the neurosensory retina.
Detailed Description
Abstract:
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Minimum age of 18 years and the presence of clinically significant DME according to the criteria of the ETDRS study
Exclusion Criteria
- •Ischemic diabetic macular edema, significant media opacity compromising the interpretation of fluorescein angiography and fundus photography, previous intraocular surgery, previous macular laser treatment, other retinal or ocular diseases, and known allergic hypersensitivity to fluorescein, indocyanine green, or iodine. General exclusion criteria included pregnancy or breast-feeding and significant medical conditions such as renal failure.
Outcomes
Primary Outcomes
best-corrected visual acuity
Time Frame: 2 years
Secondary Outcomes
- change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements(2 years)
Investigators
Jost Hillenkamp
Oberarzt, Dept. of Ophthalmology, University of Schleswig-Holstein, Kiel, Germany
University Hospital Schleswig-Holstein