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OpenTrials
Completed

NCT Number: NCT03226951

SDM Laser for Non Central Diabetic CSME

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marashi Eye Clinic

Aleppo, 2241511, Syria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subthreshold 532nm laser

Device

Subthershold 532nm laser

Primary outcomes

  1. Number of eyes with reduced macular thickness

    Time frame: 24 weeks

    Measurements of retinal thickness in the area of edema

Secondary outcomes

  1. Number of eyes with reduced vision

    Time frame: 24 weeks

    Best corrected visual acuity at the end of the study

  2. Number of eyes developing central macular edema

    Time frame: 24 weeks

  3. Number of patients achieved good glycemic control

    Time frame: 24 weeks

    By measuring HbA1C every 12 weeks from baseline

Sponsors and collaborators

Lead sponsor

Marashi Eye Clinic

Other

Registry information

Official study title

Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.