Clinical Studies:
DRVS Report 5
Early Vitrectomy for Severe Vitreous Hemorrhage in Diabetic Retinopathy: Four-Year Results
Citation: Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study Report 5. Arch Ophthalmol. 1990 Jul;108(7):958-64.
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 with early vitrectomy compared with observation/delayed vitrectomy, thought slightly less difference than in the two-year results
- At 4 years of follow-up there were significantly more Type 1 diabetics who achieved good visual acuity outcomes with early vitrectomy compared with observation/delayed vitrectomy. Thought to be due to more extensive fibrovascular proliferation and vitreoretinal adhesions in this group
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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
48 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. However, by 48 months this difference was no longer significantly present (29% versus 23.5%).
- More rapid recovery of functional vision in prompt vitrectomy group, though this became less of a difference between the groups with passing year
Poor Outcomes
- 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), and this continued to remain not significant by the 48-month timepoint.
Retinal Detachment
- More frequent retinal detachment more often in the deferral group compared with the early group, this was largely due to the marked increase in retinal detachment in Type 1 DM (duration DM <20 years) patients (early 8.6%, deferred 33.3%)
Of Note
- 30% of vitrectomy eyes had concurrent lensectomy (surgeries occurred prior to discovery of the importance of glucose-fortified infusions preventing intraoperative lens opacification)
- This may be related to increased rates of neovascular glaucoma in the early vitrectomy group compared with deferred vitrectomy group
- By 18 months >50% of the deferred surgery cohort had undergone vitrectomy, by the conclusion of the study close to 75% of patients in the deferred surgery group had undergone vitrectomy.
CONCLUSIONS
- Early vitrectomy provided advantage for obtaining better visual acuities at four years though this was not statistically significant. Early vitrectomy was particularly efficacious for Type 1 diabetics. Prompt vitrectomy also allowed for faster visual rehabilitation compared with observation, though this difference decreased between the two groups over later years of study follow-up.