Should patients on isotretinoin be excluded from corneal refractive procedures?

In this study, researchers retrospectively assessed functional outcomes when patients underwent corneal refractive procedures while taking the acne drug isotretinoin (Acutane).

Study design

This multicenter, interventional case series included 113 patients (219 eyes) who were divided into 2 study arms. Group 1 (n=82) included patients who were taking isotretinoin while group 2 (n=31) had taken isotretinoin previously but not in the last 6 months. Patients were examined 12 hours, 7 days, and 1 and 3 months after surgery.

Outcomes

The efficacy index was slightly better in group 2 (P=0.017). Visual acuity, postoperative spherical equivalent, efficacy index, predictability and safety index were all similar between groups. Neither group displayed significant intraoperative or postoperative complications.

A subgroup analysis of PRK patients showed that both postoperative sphere (P=0.041) and astigmatism (P<0.001) were better in group 2, but the difference was not clinically relevant.

Limitations

Although the study reached statistical significance in group 1 compared to group 2 in regard to PRK, it was minimal and not clinically relevant. The study also lacked a true control arm.

Clinical significance

This study shows good outcomes in patients who undergo LASIK and PRK while taking isotretinoin. Current FDA guidelines state that isotretinoin is a contraindication for LASIK refractive surgery, and these findings suggest those guidelines should be reconsidered. The authors suggest that patients taking isotretinoin should not be excluded from corneal refractive surgery if no other contraindication is present.