Non Central Diabetic Macular Edema
Conditions
Brief 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
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
Interventions
DEVICESubthreshold 532nm laser
Subthershold 532nm laser
Sponsors
Marashi Eye Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of eyes with reduced macular thickness | 24 weeks | Measurements of retinal thickness in the area of edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of eyes with reduced vision | 24 weeks | Best corrected visual acuity at the end of the study |
| Number of eyes developing central macular edema | 24 weeks | — |
| Number of patients achieved good glycemic control | 24 weeks | By measuring HbA1C every 12 weeks from baseline |
Countries
Syria
Outcome results
None listed