Back to resultsStudy on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy
Primary Purpose
Central Serous Chorioretinopathy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micropulse Laser Treatment
No treatment
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring CSC, Edema, Retinopathy
Eligibility 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
Sites / Locations
- George Washington University Medical Faculty Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Micropulse Laser Treatment
No Treatment
Arm Description
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
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
Outcomes
Primary Outcome Measures
Resolution of Fluid Build-up
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01982383
First Posted
November 6, 2013
Last Updated
March 1, 2018
Sponsor
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT01982383
Brief Title
Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy
Official Title
A Prospective Study of the Use of Micropulse 577nm Laser Treatment in Central Serous Chorioretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
CSC, Edema, Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micropulse Laser Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
No Treatment
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Micropulse Laser Treatment
Other Intervention Name(s)
Micropulse 577nm, Laser
Intervention Type
Other
Intervention Name(s)
No treatment
Primary Outcome Measure Information:
Title
Resolution of Fluid Build-up
Description
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.
Time Frame
within 1 week to 3 months after the laser procedure is completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeevan Mathura, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15005592
Citation
Ricci F, Missiroli F, Cerulli L. Indocyanine green dye-enhanced micropulsed diode laser: a novel approach to subthreshold RPE treatment in a case of central serous chorioretinopathy. Eur J Ophthalmol. 2004 Jan-Feb;14(1):74-82. doi: 10.1177/112067210401400115.
Results Reference
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PubMed Identifier
18988165
Citation
Lanzetta P, Furlan F, Morgante L, Veritti D, Bandello F. Nonvisible subthreshold micropulse diode laser (810 nm) treatment of central serous chorioretinopathy. A pilot study. Eur J Ophthalmol. 2008 Nov-Dec;18(6):934-40. doi: 10.1177/112067210801800613.
Results Reference
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PubMed Identifier
19041477
Citation
Chen SN, Hwang JF, Tseng LF, Lin CJ. Subthreshold diode micropulse photocoagulation for the treatment of chronic central serous chorioretinopathy with juxtafoveal leakage. Ophthalmology. 2008 Dec;115(12):2229-34. doi: 10.1016/j.ophtha.2008.08.026.
Results Reference
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Learn more about this trial
Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy
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