SDM Laser for Non Central Diabetic CSME

NCT03226951 | Completed

• 1 other identifier: Protocol DME 2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Non Central Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Number of eyes with reduced macular thickness

  Measurements of retinal thickness in the area of edema

  24 weeks

Secondary Outcomes (3)

• Number of eyes with reduced vision

  24 weeks

• Number of eyes developing central macular edema

  24 weeks

• Number of patients achieved good glycemic control

  24 weeks

Study Arms (1)

Subtherhold 532 nm laser

EXPERIMENTAL

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

Device: Subthreshold 532nm laser

Interventions

Subthreshold 532nm laser DEVICE

Subthershold 532nm laser

Subtherhold 532 nm laser

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marashi Eye Clinic: lead

Study Sites (1)

Marashi Eye Clinic

Aleppo, 2241511, Syria

Location

Related 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

  RESULT

Related Links

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

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: July 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: February 1, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)