SDM Laser for Non Central Diabetic CSME

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03226951
• Date of registration: 20/07/2017
• Prospective Registration: No
• Primary sponsor: Marashi Eye Clinic
• Public title: SDM Laser for Non Central Diabetic CSME
• Scientific title: Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema
• Date of first enrolment: July 1, 2017
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03226951
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Syrian Arab Republic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non Central Diabetic Macular Edema

Intervention(s)

Device: Subthreshold 532nm laser

Primary Outcome(s)

Number of eyes with reduced macular thickness [Time Frame: 24 weeks]

Secondary Outcome(s)

Number of eyes with reduced vision [Time Frame: 24 weeks]

Number of patients achieved good glycemic control [Time Frame: 24 weeks]

Number of eyes developing central macular edema [Time Frame: 24 weeks]

Secondary ID(s)

Protocol DME 2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors