SDM Laser for Non Central Diabetic CSME

Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema

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

Study Overview

• Status: Completed
• Conditions: Non Central Diabetic Macular Edema
• Intervention / Treatment: Device: Subthreshold 532nm laser

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Aleppo, Syrian Arab Republic, 2241511
    • Marashi Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subtherhold 532 nm 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	Device: Subthreshold 532nm laser; Subthershold 532nm laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eyes with reduced macular thickness	Measurements of retinal thickness in the area of edema	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marashi Eye Clinic

Publications and helpful links

General Publications

• 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

Helpful Links

• Non-central diabetic clinical significant macular edema treatment with 532nm sub threshold laser

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: Protocol DME 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No