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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01327170
Other study ID # SDMCCSC-FM
Secondary ID
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


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
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