Purpose: To compare vitreous substitution with silicone oil to perfluoropropane gas in proliferative diabetic retinopathy subjects undergoing pars plana vitrectomy (PPV) for the treatment of tractional retinal detachment or extensive fibrous proliferation.
Design: Randomized clinical trial.
Methods: Three hundred and two proliferative diabetic retinopathy subjects with tractional retinal detachment or extensive fibrous proliferation requiring PPV were enrolled into the trial. Subjects were prospectively randomized into one of two vitreous substitution groups during PPV: Group A subjects underwent 1,000 centistoke silicone oil tamponade, whereas Group B subjects underwent 14% to 16% silicone oil to perfluoropropane gas tamponade. The principal outcome was the best-corrected visual acuity at 6-month follow-up. Secondary outcomes were postoperative complications and unplanned PPV during the 6-month trial interval.
Results: Two hundred and fifty-eight subjects were randomized to receive a vitreous substitute and completed 6-month follow-up. Group B had better best-corrected visual acuity, more subjects ending up with 0.4 logarithm of the minimum angle of resolution (20/50) or better visual acuity, and more subjects ending up with 1 logarithm of the minimum angle of resolution (20/200) or better visual acuity at 6 months compared with Group A (P < 0.001, P = 0.02, P < 0.001, respectively). There were no significant differences in baseline characteristics, intraoperative or postoperative complications, or incidence of unplanned PPV between groups.
Conclusion: This trial demonstrated that vitreous substitution with silicone oil to perfluoropropane gas resulted in better visual acuity at 6 months compared with silicone oil tamponade in proliferative diabetic retinopathy patients undergoing PPV for tractional retinal detachment or extensive fibrous proliferation. Surgeons should consider silicone oil to perfluoropropane gas tamponade as the first-line vitreous substitute in this patient population.
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