SDM Laser for Non Central Diabetic CSME

Non Central Diabetic Macular Edema Clinical Trial

Official title:

Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226951
• Other study ID #: Protocol DME 2
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: October 2018
• Source: Marashi Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 1, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Edema
• Non Central Diabetic Macular Edema

Intervention

Device:
• Subthreshold 532nm laser
Subthershold 532nm laser

Locations

Country	Name	City	State
Syrian Arab Republic	Marashi Eye Clinic	Aleppo

Sponsors (1)

Lead Sponsor	Collaborator
Marashi Eye Clinic

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eyes with reduced macular thickness	Measurements of retinal thickness in the area of edema	24 weeks
Secondary	Number of eyes with reduced vision	Best corrected visual acuity at the end of the study	24 weeks
Secondary	Number of eyes developing central macular edema		24 weeks
Secondary	Number of patients achieved good glycemic control	By measuring HbA1C every 12 weeks from baseline	24 weeks

External Links

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