SDM Laser for Non Central Diabetic CSME

Marashi Eye Clinic

Status: Completed

Conditions: Non Central Diabetic Macular Edema

Treatments: Device: Subthreshold 532nm laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03226951

Protocol DME 2

Details and patient eligibility

About

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

Full 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

Enrollment: 8 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Subtherhold 532 nm laser

Experimental group

Description:

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

Treatment:

Device: Subthreshold 532nm laser