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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. Rationale: Vitrectomy for DME.

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Vitrectomy Outcomes in Eyes with Diabetic Macular Edema, Visual Loss, and Vitreomacular Traction

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  1. 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.

  2. 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

  3. Rationale for Prospective Cohort Study • 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

  4. Overall Study Design 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 Vitrectomy performed by the investigator’s usual routine.

  5. Follow-up and Treatment Schedule Intraop/Postop Data and Complications Collected Vitrectomy 3 Month Follow-Up • BCVA • OCT • 7-field photos at 6 mos 6 Month Follow-Up

  6. Main Outcomes: 6 months • Visual acuity • Retinal thickening on OCT • Complications 

  7. ARVO 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

  8. Results

  9. Study Enrollment • 241 eyes enrolled and underwent vitrectomy for DME at 35 clinical sites • Indication for surgery VMIA: 227 eyes • 87 eyes in primary cohort • Vitreomacular traction • VA 20/63 to 20/400 • OCT CSF >300 microns • Cataract extraction not performed

  10. Visit Completion • Primary Cohort (n=87) • 98% at 3-month visit • 96% at 6-month visit 11

  11. Baseline Characteristics

  12. Baseline Characteristics Continued

  13. Baseline Characteristics Continued

  14. Surgery Characteristics

  15. Surgery Characteristics

  16. Surgery Characteristics Continued

  17. Visual 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

  18. Primary Outcome:Primary Cohort Mean Retinal Thickness

  19. Primary Outcome:Primary Cohort Change in Retinal Thickness

  20. Primary Outcome:Primary Cohort Change in Visual Acuity

  21. Complications 0-6 Months

  22. Results • 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

  23. Follow-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

  24. Discussion

  25. Conclusions: 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

  26. Study 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

  27. Study 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 28

  28. Thank You • 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 For further information and all DRCR Network financial disclosures, go to www.drcr.net 29

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