Vitrectomy Outcomes in Eyes with Diabetic Macular Edema, Visual

Loss, and Vitreomacular Traction

Vitrectomy Outcomes in Eyes with Diabetic Macular Edema, Visual

Loss, and Vitreomacular Traction

Sponsored by the National Eye Institute,

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

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Rationale:Vitrectomy for DME

Rationale:Vitrectomy for DME

Case series report resolution of DME and improving VA

Most series not prospective, many in preOCT era

Possible positive impacts:

Anatomic resolution of vitreomacular tractional forces

Physiologic changes: improved oxygenation or beneficial changes in retinal microenvironment

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Lack of investigator equipoise: surgery indicated in eyes with VMT and reduced VA

Cohort study: Prospective data collection, standardized protocol

Data provide reference for future surgical trials

Rationale for Prospective Cohort Study

Rationale for Prospective Cohort Study

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Overall Study DesignOverall Study Design

Vitrectomy performed by the investigator’s usual routine.

Prospective Cohort Study

At least one eye meeting all of the following criteria:• DME on clinical exam• BCVA letter score > 20/400• Presence of vitreomacular traction associated

with macular edema OR judgment that edema will not to respond to focal/grid photocoagulation

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Follow-up and Treatment ScheduleFollow-up and Treatment Schedule

BCVA

OCT

7-field photos at 6 mos

Vitrectomy Intraop/Postop Data and Complications Collected

3 Month Follow-Up

6 Month Follow-Up

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Main Outcomes: 6 monthsMain Outcomes: 6 months Visual acuity

Retinal thickening on OCT Complications 

ARVO Report: Primary CohortARVO Report: Primary Cohort Investigator states that vitreomacular

traction was reason for vitrectomy Visual acuity 20/63 to 20/400 Central subfield >300 microns on OCT Cataract extraction not performed during

vitrectomy

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ResultsResults

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241 eyes enrolled and underwent vitrectomy for DME at 35 clinical sites

Indication for surgery VMIA: 227 eyes

87 eyes in primary cohortVitreomacular traction VA 20/63 to 20/400 OCT CSF >300 microns Cataract extraction not performed

Study EnrollmentStudy Enrollment

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Primary Cohort (n=87)

• 98% at 3-month visit

• 96% at 6-month visit

Visit CompletionVisit Completion

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Baseline CharacteristicsBaseline Characteristics

Primary Cohort (n=87)

Median Age 66 years

Women (%) 45%

White (%) 79%

Diabetes Type (%): Type I /Type 2 16%/ 84%

Median Visual Acuity 20/100

Median OCT CSF thickness 491 microns

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Baseline Characteristics ContinuedBaseline Characteristics Continued

Primary Cohort

Retinopathy Severity NPDR 31%

PDR 64%

Pseudophakic 57%

Epiretinal Membranes Present

No 24%

Probable 22%

Definite 49%

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Primary Cohort

Status of vitreous on clinical examination

Attached 56%

Partially attached 32%

Detached 6%

Uncertain 6%

Reasons for Vitrectomy

Vitreomacular interface abnormality

100%

Unresponsive to other therapies

31%

Baseline Characteristics ContinuedBaseline Characteristics Continued

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Surgery CharacteristicsSurgery Characteristics

Primary Cohort (n=87)

Vitrectomy System

19/20 gauge 40%

25 gauge 49%

Other 10%

Epiretinal Membrane Peeled 61%

ILM Removed 54%

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Primary Cohort (n=87)

Agents Used to Improve Visualization

60%

Triamcinolone 34%

ICG 25%

Other 5%

Laser Used 55%

PRP 39%

Focal 5%

Surgery CharacteristicsSurgery Characteristics

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Surgery Characteristics ContinuedSurgery Characteristics Continued

Primary Cohort

Cryotherapy Used 8%

Corticosteroids Used at Close 64%

Intravitreal 43%

Peribulbar/Subconj/Sub Tenon’s 40%

Posterior Capsulotomy Performed 8%

Epiretinal Membranes Present

No 39%

Probable 15%

Definite 46%

Visual Results: Vtx for DMEVisual Results: Vtx for DME

Anatomic: Median decrease in OCT CSF thickening of 153 microns

42% resolution of central DME (CSF≤250 microns)

Two-thirds of eyes had 50% reduction or more

Functional: Visual acuity improved ≥ 10 letters (= 2 lines)

in 37% at 6 months VA decreased ≥ 10 lines in 23% at 6 months

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Primary Outcome:Primary Cohort Mean Retinal Thickness

Primary Outcome:Primary Cohort Mean Retinal Thickness

0

100

200

300

400

500

600

Baseline 3 Months 6 Months

Mean CST

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Primary Outcome:Primary Cohort Change in Retinal Thickness

Primary Outcome:Primary Cohort Change in Retinal Thickness

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Primary Outcome:Primary Cohort Change in Visual Acuity

Primary Outcome:Primary Cohort Change in Visual Acuity

≤ -10

-9 - -5

-4 - +4

+5 - +9

≥ +10

≤ -10

-9 - -5

-4 - +4

+5 - +9

≥ +10

0%

20%

40%

60%

80%

100%

3 month 6 month

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Primary CohortOperative complications 7%Any postoperative complications/AE – (%) 18%

Vitreous Hemorrhage 6%Development of Vitreomacular Interface Abnormalities

2%

Elevated IOP Requiring Treatment 8%Retinal Detachment 3%Retinal Tear 0Endophthalmitis 1%Macular Ischemia 0Double Vision 2%Other 6%

Complications 0-6 MonthsComplications 0-6 Months

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ResultsResults

4/8 eyes with RD, endophthalmitis, or VH lost 10 or more letters at 6 months

For every 100 microns CSF decrease, improvement in VA 2.6 letters

CSF retinal thickness changes stabilize at 3 months after vitrectomy

 

Follow-up AnalysisFollow-up Analysis

1 year data on this cohort

Analysis of the entire cohort of patients with VMT: N=227

Impact on outcomes: pseudophakia, baseline VA, severity of retinopathy, ERM peeling, ILM peeling

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DiscussionDiscussion

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Conclusions: DME, Visual Loss, Vitreomac TractionConclusions: DME, Visual Loss, Vitreomac Traction

Marked anatomic improvement:• 153 microns mean CSF decrease• 43% <250 microns at 6 months• Two-thirds > 50% improvement in

CSF thickening

• 37% improved by 10 or more letters at 6 mo

• 22% declined by 10 or more letters at 6 mo

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Study LimitationsStudy Limitations

Unknown how these cases would have fared without treatment

Judgment that indication for surgery was vitreomacular traction was made by the investigator, not a reading center

Variety of surgical maneuvers employed

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Study StrengthsStudy Strengths

Standardized protocol across 35 diverse clinical sites in the U.S.

Little loss to follow-up through 6 months

“Real world” scenario: judgment of VMT made by experienced surgeons

Numbers allow subgroup analysis (n=227)

Provides a reference going forward

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For further information and all DRCR Network financial disclosures,

go to www.drcr.net

35 clinical study sites

Subjects who volunteered to participate in this trial

DRCR Network Data and Safety Monitoring Committee

Juvenile Diabetes Research Foundation (JDRF)

DRCR Network investigators and staff

Thank YouThank You