Non Central Diabetic Macular Edema Clinical Trial
Official title:
Sub Threshold Laser for Non Central Diabetic Clinical Significant Macular Edema
Verified date | October 2018 |
Source | Marashi Eye Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Marashi Eye Clinic | Aleppo |
Lead Sponsor | Collaborator |
---|---|
Marashi Eye Clinic |
Syrian Arab Republic,
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
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 |