Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

Not Applicable

Completed

• Conditions: Central Serous Chorioretinopathy
• Interventions: Procedure: Subthreshold diode micropulse laser

• Registration Number: NCT01327170
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The aim of this study was to evaluate safety and therapeutic response to micropulse diode 810nm laser treatment in patients with chronic central serous chorioretinopathy.

Detailed Description

Most of the cases of central serous chorioretinopathy (CSC) recur spontaneously within three months of disease. After 3 months without resolution of acute CSC or in chronic CSC, continuous wave laser photocoagulation or photodynamic therapy should be considered. Direct threshold continuous photocoagulation treatment can shorten the duration of the serous detachment, but it is not appropriate for juxtafoveal or subfoveal leakage point.Subvisible photocoagulation potentially localizes and decreases chorioretinal thermic burn. Subthreshold diode micropulse (SDM) laser using a 810nm diode laser may spare the damage to the neural retina by raising the temperature of the RPE to just below the protein-denaturation threshold so that the thermal wave that reaches the neural retina is insufficient to cause neither damage nor clinically visible end-point. This therapeutic laser modality offers the possibility to minimize the iatrogenic retinal lesion.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-12
• Study Completion: 2010-06
• Status Verified: 2011-03
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-30
• Last Update Submitted: 2011-03-30
• Study First Posted: 2011-04-01
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Chronic active central serous chorioretinopathy lasting more than 6 months
• Leakage at fluorescein angiogram

Exclusion Criteria

• Opacities of the clear refractive media of the eye
• Any intraocular surgery within the 6 months prior to study entry
• Prior vitrectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subthreshold diode micropulse laser	Subthreshold diode micropulse laser	Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy
Sham	Subthreshold diode micropulse laser	Sham group simulating the laser treatment

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	6 months	Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Macular subretinal fluid	6 months	Central macular thickness measured by spectral-domain optical coherence tomography at baseline, 1, 3, 6, 9 and 12 months
Leakage at fluorescein angiogram	6 months	Leakage at fluorescein angiogram evaluated at baseline, 3, 6, 9 and 12 months

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil