Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327170
• Other study ID #: SDMCCSC-FM
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: March 30, 2011
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2011
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Procedure:
• Subthreshold diode micropulse laser

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity	Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months	6 months	Yes
Secondary	Macular subretinal fluid	Central macular thickness measured by spectral-domain optical coherence tomography at baseline, 1, 3, 6, 9 and 12 months	6 months	No
Secondary	Leakage at fluorescein angiogram	Leakage at fluorescein angiogram evaluated at baseline, 3, 6, 9 and 12 months	6 months	Yes