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Completed

NCT Number: NCT01327170

Micropulse Diode Laser Treatment for Chronic Central Serous Chorioretinopathy

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.

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Key information

Conditions

Central Serous Chorioretinopathy Eye Diseases Retinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo

São Paulo, 04023-062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subthreshold diode micropulse laser

Procedure

Primary outcomes

  1. Best corrected visual acuity

    Time frame: 6 months

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

Secondary outcomes

  1. Macular subretinal fluid

    Time frame: 6 months

    Central macular thickness measured by spectral-domain optical coherence tomography at baseline, 1, 3, 6, 9 and 12 months

  2. Leakage at fluorescein angiogram

    Time frame: 6 months

    Leakage at fluorescein angiogram evaluated at baseline, 3, 6, 9 and 12 months

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 1, 2011
Registry last updated
Apr 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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