Back to resultsSDM Laser for Non Central Diabetic CSME
Primary Purpose
Non Central Diabetic Macular Edema
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Subthreshold 532nm laser
Sponsored by
About this trial
This is an interventional treatment trial for Non Central Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Patients with central diabetic macular edema Best corrected visual acuity is 20/30 or more
- Non central Macular thickness more than 250 microns
- Patients who are able to come for all follow-up
Exclusion Criteria:
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
- History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
Sites / Locations
- Marashi Eye Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subtherhold 532 nm laser
Arm Description
Applying 532nm subtherhold laser with 5% duty cycle using high density low intensity protocol at the area of non central clinical significant macular edema
Outcomes
Primary Outcome Measures
Number of eyes with reduced macular thickness
Measurements of retinal thickness in the area of edema
Secondary Outcome Measures
Number of eyes with reduced vision
Best corrected visual acuity at the end of the study
Number of eyes developing central macular edema
Number of patients achieved good glycemic control
By measuring HbA1C every 12 weeks from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03226951
Brief Title
SDM Laser for Non Central Diabetic CSME
Official Title
Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marashi Eye Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the progression of non central CSME to central CSME in compare to glycemic control
Detailed Description
interventional randomised masked study will recruit patients have diabetes mellitus with non central CSME with good vision into two groups : 1st SDM laser with glycemic control 2nd SHAM laser with Glycemic control where BCVA will be recorded every month starting from baseline to 24 weeks where OCT will be recorded every 8 weeks from baseline to 24 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Central Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subtherhold 532 nm laser
Arm Type
Experimental
Arm Description
Applying 532nm subtherhold laser with 5% duty cycle using high density low intensity protocol at the area of non central clinical significant macular edema
Intervention Type
Device
Intervention Name(s)
Subthreshold 532nm laser
Intervention Description
Subthershold 532nm laser
Primary Outcome Measure Information:
Title
Number of eyes with reduced macular thickness
Description
Measurements of retinal thickness in the area of edema
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Number of eyes with reduced vision
Description
Best corrected visual acuity at the end of the study
Time Frame
24 weeks
Title
Number of eyes developing central macular edema
Time Frame
24 weeks
Title
Number of patients achieved good glycemic control
Description
By measuring HbA1C every 12 weeks from baseline
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with central diabetic macular edema Best corrected visual acuity is 20/30 or more
Non central Macular thickness more than 250 microns
Patients who are able to come for all follow-up
Exclusion Criteria:
Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
Facility Information:
Facility Name
Marashi Eye Clinic
City
Aleppo
ZIP/Postal Code
2241511
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Marashi A. Non-central diabetic clinical significant macular edema treatment with 532nm sub threshold laser. Adv Ophthalmol Vis Syst. 2018;8(3):151-154. DOI: 10.15406/aovs.2018.08.0029
Results Reference
result
Links:
URL
http://medcraveonline.com/AOVS/AOVS-08-00291.pdf
Description
Non-central diabetic clinical significant macular edema treatment with 532nm sub threshold laser
Learn more about this trial
SDM Laser for Non Central Diabetic CSME
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