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Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Retinopathy

NCT00987077 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-09-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of Selective Retina Therapy (SRT) for treating acute idiopathic central serous chorioretinopathy (ICSC). Patients with acute symptomatic ICSC of at least 3 months duration were recruited. The patients were randomized by equal terms to SRT- (Treatment) and control group. After 3 months follow up patients of control group with persistence of disease activity were allocated to crossover group and received either SRT. Crossover group was followed up for further 3 months.

The primary outcome measure of the study are the serial changes in Early Treatment of Diabetic Retinopathy Study (ETDRS) letterscore and edema in optical coherence tomography (OCT) at 3 months. Secondary outcome measures included the proportion of eyes with complete absorption of subretinal fluid, leakage in fluorescein angiography and the systemic and ocular complications during the study at 3 months.

Conditions

  • Central Serous Chorioretinopathy
  • Selective Retina Therapy

Interventions

DEVICE

Selective Retina Therapy (SRT)

SRT (pulsed double-Q-switched Nd-YLF laser, wavelength 527 nm, t=1.7 µs, energy 100-370 μJ).

Sponsors & Collaborators

  • Medical Laser Center Lübeck, Lübeck, Germany

    collaborator UNKNOWN

  • Institute for Medical Informaties and Statistics Kiel, Germany

    collaborator UNKNOWN

  • University of Kiel

    lead OTHER

Principal Investigators

  • Johann J Roider, Professor · Department of Ophthalmology University of Kiel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00987077 on ClinicalTrials.gov