SDM Laser for Non Central Diabetic CSME | NCT03226951

Studies
SDM Laser for Non Central Diabetic CSME

NCT03226951

Sponsor

Marashi Eye Clinic

Status

Completed

Last Update Posted

Oct 29, 2018Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Non Central Diabetic Macular Edema

Interventions

Subthreshold 532nm laser

Countries

Syria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Jan 31, 2018Actual

Completion Date

Feb 1, 2018Actual

First Submitted Date

Jul 20, 2017

First Submission Date that Met QC Criteria

Jul 20, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2018

Last Update Posted Date

Oct 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Subthreshold 532nm laser	Device	Subthershold 532nm laser	Subtherhold 532 nm laser

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of eyes with reduced macular thickness	Measurements of retinal thickness in the area of edema	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of eyes with reduced vision	Best corrected visual acuity at the end of the study	24 weeks
Number of eyes developing central macular edema		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Marashi Eye Clinic		Aleppo		2241511	Syria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies