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Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

Primary Purpose

Central Serous Chorioretinopathy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Subthreshold diode micropulse laser
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Subthreshold diode micropulse laser

Sham

Arm Description

Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy

Sham group simulating the laser treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2011
Last Updated
March 30, 2011
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01327170
Brief Title
Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy
Official Title
Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy: Evaluation by Fundus Autofluorescence and Spectral Domain Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subthreshold diode micropulse laser
Arm Type
Active Comparator
Arm Description
Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham group simulating the laser treatment
Intervention Type
Procedure
Intervention Name(s)
Subthreshold diode micropulse laser
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Macular subretinal fluid
Description
Central macular thickness measured by spectral-domain optical coherence tomography at baseline, 1, 3, 6, 9 and 12 months
Time Frame
6 months
Title
Leakage at fluorescein angiogram
Description
Leakage at fluorescein angiogram evaluated at baseline, 3, 6, 9 and 12 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda P Magalhaes, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

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Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

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