Back to resultsSubthreshold Micropulse Laser Treatment of Acute Central Serous Chorioretinopathy
Primary Purpose
Acute Central Serous Retinopathy With Subretinal Fluid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Micropulse laser
Sponsored by
About this trial
This is an interventional treatment trial for Acute Central Serous Retinopathy With Subretinal Fluid
Eligibility Criteria
Inclusion Criteria:
- acute CSCR
Exclusion Criteria:
- chronic CSCR Previously treated case of Acute CSCR
Sites / Locations
- Minia University Hospital
Outcomes
Primary Outcome Measures
change in visual acuity
resolution of subretinal fluid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05447117
Brief Title
Subthreshold Micropulse Laser Treatment of Acute Central Serous Chorioretinopathy
Official Title
Subthreshold Micropulse 532 nm Green Laser Treatment of Acute Central Serous Chorioretinopathy: 18-month Results
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of 532 nm green subthreshold micropulse laser (GSML) as a treatment for acute central serous chorioretinopathy (CSCR).
Detailed Description
This prospective study included 42 eyes of 42 patients with acute CSCR treated with IRIDEX™ IQ 532 nm GSML. The study was conducted at Minia University Hospital and Genaidy Ophthalmology Center, Minia, Egypt between October 2019 and May 2022. All patients were subjected to a complete ophthalmological examination, fluorescein angiography (FA) and optical coherence tomography (OCT) at baseline and each follow-up visit 1, 3 and 18 months after laser treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Central Serous Retinopathy With Subretinal Fluid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Micropulse laser
Intervention Description
532 nm green subthreshold micropulse laser (GSML) as a treatment for acute central serous chorioretinopathy (CSCR).
Primary Outcome Measure Information:
Title
change in visual acuity
Description
resolution of subretinal fluid
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute CSCR
Exclusion Criteria:
chronic CSCR Previously treated case of Acute CSCR
Facility Information:
Facility Name
Minia University Hospital
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Subthreshold Micropulse Laser Treatment of Acute Central Serous Chorioretinopathy
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