Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy: Evaluation by Fundus Autofluorescence and Spectral Domain Optical Coherence Tomography

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.

Study Overview

• Status: Completed
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Procedure: Subthreshold diode micropulse laser

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04023-062
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subthreshold diode micropulse laser; Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy	Procedure: Subthreshold diode micropulse laser
Sham Comparator: Sham; Sham group simulating the laser treatment	Procedure: Subthreshold diode micropulse laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Fernanda P Magalhaes, MD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): April 1, 2011

Study Record Updates

• Last Update Posted (Estimate): April 1, 2011
• Last Update Submitted That Met QC Criteria: March 30, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy
• Other Study ID Numbers: SDMCCSC-FM