Ophthalmic surgery and lasers · 1997
Complex retinal detachment treated with silicone oil or sulfur hexafluoride gas: a randomized clinical trial.
Клиническое исследованиеСравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Hammer M, Margo C E, Grizzard W S
Аннотация
BACKGROUND AND OBJECTIVE: To determine if either silicone oil or sulfur hexafluoride gas (SF6) is superior to the other in the treatment of complex retinal detachment after previously failed vitreous surgery.
PATIENTS AND METHODS: In this randomized clinical trial, 18 patients received treatment with silicone oil and 16 patients received SF6. The primary outcome was defined as successful anatomic attachment of the retina. Secondary outcomes included the time to retinal detachment, visual acuity, anatomic macular attachment, and any complications of surgery.
RESULTS: The odds of successful reattachment with silicone oil were 50% greater than they were with SF6, but this difference was not statistically significant. There were no differences between the two groups in any of the secondary outcomes.
CONCLUSIONS: This study did not have enough statistical power to detect a small but clinically important difference between the two treatment groups. Physicians must use their clinical judgment to select a vitreal substitute for complex retinal detachment when clinical trials are inconclusive. Data pooling is one method of overcoming the limitation of clinical trials with small sample sizes.
PATIENTS AND METHODS: In this randomized clinical trial, 18 patients received treatment with silicone oil and 16 patients received SF6. The primary outcome was defined as successful anatomic attachment of the retina. Secondary outcomes included the time to retinal detachment, visual acuity, anatomic macular attachment, and any complications of surgery.
RESULTS: The odds of successful reattachment with silicone oil were 50% greater than they were with SF6, but this difference was not statistically significant. There were no differences between the two groups in any of the secondary outcomes.
CONCLUSIONS: This study did not have enough statistical power to detect a small but clinically important difference between the two treatment groups. Physicians must use their clinical judgment to select a vitreal substitute for complex retinal detachment when clinical trials are inconclusive. Data pooling is one method of overcoming the limitation of clinical trials with small sample sizes.