Comparison of Modified ETDRS and Mild Macular Grid Laser Photocoagulation Strategies for Diabetic Ma...
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Comparison of Modified ETDRS and Mild Macular Grid Laser Photocoagulation Strategies for Diabetic Macular Edema Sponsored by the National Eye Institute, National Institutes of Health, U.S. Department of Health and Human Services. Compare two laser photocoagulation techniques:

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Objective

Comparison of Modified ETDRS and Mild Macular Grid Laser Photocoagulation Strategies for Diabetic Macular Edema

Sponsored by the National Eye Institute,

National Institutes of Health, U.S. Department of Health and Human Services


Objective

Compare two laser photocoagulation techniques:

Modified ETDRS focal photocoagulation (mETDRS) to areas of edema

Direct treatment to microaneurysms

Grid to diffuse leakage

Mild macular grid (MMG) laser technique

small mild burns throughout macula

in areas with and without edema

no direct treatment of microaneurysms

Objective


Background

Background

  • Presumed mechanism of focal photocoagulation include

    • Closure of microaneurysms

    • Reduced blood flow leading to auto-regulation and reduced edema

    • Improved oxygenation leading to auto-regulation and reduced edema

    • Stimulation of biochemical processes in RPE

  • Would light widespread laser (mild macular grid, MMG) to the macula be effective?

  • Pilot clinical trial


Objective

Study Design

Randomized Clinical Trial (Pilot Study)

  • Major Eligibility Criteria Assessed:

    >18 years old

    Type 1 or type 2 diabetes

  • Study eye meets the following criteria (subjects allowed 2 study eyes):

  • Best corrected electronic ETDRS visual acuity score of ≥19

  • Definite retinal thickening on clinical exam due to previously untreated DME

  • Retinal thickness measured on OCT of 250 μm or more in the central subfield or 300 μm or more in at least 1 of the 4 inner subfields

  • Had no prior laser or other treatment for DME.

  • Subjects with 2 study eyes: 1 eye was randomly assigned to receive 1 treatment and 1 eye was assigned to receive the other.

mETDRS N=162 Eyes

MMG N=161


Mild macular grid

Mild Macular Grid

40 minutes post laser treatment

6 weeks post laser treatment


Objective

Follow-up and Treatment Schedule

  • Measurements by certified Evaluator

  • Best-corrected electronic ETDRS visual acuity

  • OCT-measured retinal thickness

  • Macular laser photocoagulation was repeated if DME persisted and such treatment was warranted in the opinion of the investigator, according to the treatment guidelines.

3.5 Month

± 2 Weeks

.

.

.

8 Month

± 4 Weeks

.

.

.

Primary outcome: Change in OCT

Secondary Outcome: Change in visual acuity

(Method: Repeated measures least squares regression models)

12 Month

± 4 Weeks


Baseline demographics and clinical characteristics

Baseline Demographics and Clinical Characteristics


Baseline demographics and clinical characteristics1

Baseline Demographics and Clinical Characteristics


Baseline demographics and clinical characteristics cont

Baseline Demographics and Clinical Characteristics Cont.


Baseline demographics and clinical characteristics cont1

Baseline Demographics and Clinical Characteristics Cont.


Mean central subfield thickness

Mean Central Subfield Thickness


Objective

Percent Edema Resolved for Central Subfield Thickness

P=0.56

P=0.23

P=0.29


Percent of edema resolved for weighted inner zone thickness

Percent of Edema Resolved for Weighted Inner Zone Thickness

P=0.07

P=0.02

P=0.57

Note: Weighted inner zone thickness is a weighted average of the thickness in the central and 4 inner subfields


Percent of edema resolved for maximum retinal thickening

Percent of Edema Resolved for Maximum Retinal Thickening

P=0.93

P=0.26

P=0.57

Note: Maximum thickening is the maximum amount of excess thickness of the central and 4 inner subfields


Percent of edema resolved for retinal volume

Percent of Edema Resolved for Retinal Volume

P=0.01

P=0.12

P=0.31

Note: Retinal volume is a weighted average of the thickness in the central, 4 inner and 4 outer subfields converted to mm3


Percent with 10 letter improvement in visual acuity

Percent with ≥ 10 Letter Improvement in Visual Acuity


Percent with 10 letter worsening in visual acuity

Percent with ≥ 10 Letter Worsening in Visual Acuity


Summary

Summary

  • Maximum retinal thickening in the inner zone (within 1500 microns of macular center), central subfield thickness, weighted inner zone thickness and retinal volume decreased in both groups

  • MMG less effective than mETDRS in reducing retinal thickening

  • Visual acuity similar in both groups


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