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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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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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
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