Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

NCT ID: NCT01327170

Last Updated: 2011-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Central Serous Chorioretinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Subthreshold diode micropulse laser

Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy

Group Type ACTIVE_COMPARATOR

Subthreshold diode micropulse laser

Intervention Type PROCEDURE

Sham

Sham group simulating the laser treatment

Group Type SHAM_COMPARATOR

Subthreshold diode micropulse laser

Intervention Type PROCEDURE

Interventions

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Subthreshold diode micropulse laser

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of São Paulo

Principal Investigators

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Fernanda P Magalhaes, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.

Reference Type DERIVED
PMID: 40522203 (View on PubMed)

Other Identifiers

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SDMCCSC-FM

Identifier Type: -

Identifier Source: org_study_id

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