SDM Laser for Non Central Diabetic CSME

Not Applicable

Completed

• Conditions: Non Central Diabetic Macular Edema
• Interventions: Device: Subthreshold 532nm laser

• Registration Number: NCT03226951
• Lead Sponsor: Marashi Eye Clinic

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

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-24
• Primary Completion: 2018-01-31
• Study Completion: 2018-02-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subtherhold 532 nm laser	Subthreshold 532nm laser	Applying 532nm subtherhold laser with 5% duty cycle using high density low intensity protocol at the area of non central clinical significant macular edema

Primary Outcome Measures

Name	Time	Method
Number of eyes with reduced macular thickness	24 weeks	Measurements of retinal thickness in the area of edema

Secondary Outcome Measures

Name	Time	Method
Number of patients achieved good glycemic control	24 weeks	By measuring HbA1C every 12 weeks from baseline
Number of eyes with reduced vision	24 weeks	Best corrected visual acuity at the end of the study
Number of eyes developing central macular edema	24 weeks

Trial Locations

Locations (1)

Marashi Eye Clinic; 🇸🇾 Aleppo, Syrian Arab Republic