Clinical Studies:
DRVS Report 2
Early Vitrectomy for Severe Vitreous Hemorrhage in Diabetic Retinopathy
Citation: Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 2. The Diabetic Retinopathy Vitrectomy Study Research Group. Arch Ophthalmol. 1985 Nov;103(11):1644-52.
Key Points
- Compared early vitrectomy with conventional management (observation with later vitrectomy after 1 year) in recent severe diabetic vitreous hemorrhage (visual acuity 5/200 or less for at least 1 month)
- There were significantly more patients who achieved good final visual acuity outcomes (10/20 or better) with early vitrectomy compared with observation/delayed vitrectomy (25% versus 15%)
- At 2 years of follow-up there were significantly more Type 1 diabetics who achieved good visual acuity outcomes (10/20 or better) with early vitrectomy compared with observation/delayed vitrectomy (36% versus 12%). There was no significant difference in Type 2 diabetics.
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Objective
To compare outcomes of early vitrectomy compared with observation/delayed vitrectomy in patients with severe vitreous hemorrhage in diabetic retinopathy
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STUDY DESIGN
Randomized, multicenter, interventional clinical trial DRVS sites
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Duration
24 months
STUDY SUBJECTS
- Adults (age >18)
- Diagnosis of diabetes mellitus (either Type 1 or Type 2)
- Sudden vision loss due to severe vitreous hemorrhage
- BCVA between 5/200 and LP
Major inclusion criteria:
- Photocoagulation within three months prior to randomization
- Severe NVI, NVG or IOP more than 30mmHg despite treatment
- Total retinal detachment, or macular detachment on ultrasound
- History of prior vitrectomy
Major exclusion criteria
RANDOMIZATION SCHEME AND INTERVENTIONS
Randomized 1:1
(a) Early vitrectomy
(b) Deferral of vitrectomy (could be performed at 1 year)
RESULTS
Study population
- 616 eyes from 594 patients randomized, 308 early vitrectomy, 308 deferred vitrectomy
Visual acuity end-points
- Percentage of eyes with visual acuity of 10/20 or better at 24 months: 25% in early vitrectomy group versus 15% in the deferred vitrectomy group
- More rapid recovery of functional vision in prompt vitrectomy group (1 year, 24% versus 5%)
- Percentage of eyes with NLP vision: rose rapidly in early vitrectomy group (20% at one year) compared with the deferred vitrectomy group (4%), however by 24 months there was no significant difference between these groups (24.9% versus 19.3%, respectively)
Recurrent Vitreous Hemorrhage
- Recurrent Vitreous hemorrhage up to 49% in aflibercept group compared with 15% vitrectomy group (significantly different)
Exploratory Outcome- DME
- At 24 weeks significantly more DME in vitrectomy group compared with aflibercept group (31% versus 8%)
Adverse events
- 30% of vitrectomy eyes had concurrent lensectomy (surgeries occurred prior to discovery of the importance of glucose-fortified infusions preventing intraoperative lens opacification)
- New or worsened rhegmatogenous retinal detachment in 4% aflibercept, 5% vitrectomy
- Cataract extraction in 49% of aflibercept group and 44% of the vitrectomy group
CONCLUSIONS
- Early vitrectomy provided advantage for obtaining visual acuity of 10/20 or better at two years, which was particularly true for Type 1 diabetics. Prompt vitrectomy also allowed for faster visual rehabilitation compared with observation.