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Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT01982383
Recruitment Status : Terminated (lack of enrollment)
First Posted : November 13, 2013
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
George Washington University

Brief Summary:
The investigators hypothesis is that using the micropulse laser in patient with Central Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in significantly minimizing visual recovery time from this disease as well as potentially preventing recurrences.

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Device: Micropulse Laser Treatment Other: No treatment Not Applicable

Detailed Description:
The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity. This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of the Use of Micropulse 577nm Laser Treatment in Central Serous Chorioretinopathy
Study Start Date : November 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Micropulse Laser Treatment
Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine
Device: Micropulse Laser Treatment
Other Names:
  • Micropulse 577nm
  • Laser

Placebo Comparator: No Treatment
Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending
Other: No treatment



Primary Outcome Measures :
  1. Resolution of Fluid Build-up [ Time Frame: within 1 week to 3 months after the laser procedure is completed ]
    Central Serous Choroidopathy is a disease that causes fluid to build up under the retina,the back part of the inner eye that sends sight information to the brain. The objective here is to apply 577nm of micropulse laser to see if CSC resolution occurs and measuring it through ocular coherence tomography (retinal imaging), vision score, and visual field testing for retinal sensitivity.



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with new diagnosis of CSC and no other comorbidities or prior retinal treatment
  • Patients ranging from 30 to 60 years of age

Exclusion Criteria:

  • Patients with no case of CSC
  • Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration
  • Patients with prior retinal treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982383


Locations
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United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Investigators
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Principal Investigator: Jeevan Mathura, MD George Washington University