SDM Laser for Non Central Diabetic CSME

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-02-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Non Central Diabetic Macular Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subtherhold 532 nm laser

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

Group Type EXPERIMENTAL

Subthreshold 532nm laser

Intervention Type DEVICE

Subthershold 532nm laser

Interventions

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Subthreshold 532nm laser

Subthershold 532nm laser

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No