Systemic supplemental oxygen therapy during accelerated corneal crosslinking for progressive keratoconus: randomized clinical trial

Abstract

Purpose: To investigate the potential additive effect of systemic supplemental oxygen administered during accelerated corneal crosslinking (CXL) for progressive keratoconus (KC).

Setting: Academic center.

Design: Randomized clinical trial.

Methods: Eyes with progressive KC randomized to 3 different CXL protocols were included. The first group (OA-CXL) included 19 eyes that underwent an accelerated CXL protocol (9 mW/cm2 for 10 minutes) while receiving systemic oxygen at a rate of 5 L/min for 10 minutes. The second group consisted of 14 eyes undergoing the same accelerated CXL protocol without supplemental oxygen therapy (A-CXL). The third group (C-CXL) comprised 14 eyes undergoing conventional CXL according to the Dresden protocol. All subjects were followed up for at least 6 months. Visual acuity, keratometry and corneal biomechanical parameters including corneal hysteresis and corneal resistance factor (CRF) were measured preoperatively and 6 months postoperatively.

Results: Reduction in maximum keratometry (Kmax) was significantly greater in the OA-CXL group (P = .01). At baseline, the mean Kmax was 54.31 ± 3.64 diopters (D) in the OA-CXL group, 54.66 ± 4.99 D in the A-CXL group, and 56.03 ± 5.28 D in the C-CXL group (P = .58), which reached 53.58 ± 3.24 D, 54.59 ± 4.65 D, and 55.87 ± 4.73 D at 6 months in the 3 study groups, respectively (P = .115). The mean CRF increased significantly only in the OA-CXL group from a baseline value of 6.32 ± 2.12 mm Hg to 7.38 ± 1.88 mm Hg at 6 months (P = .009).

Conclusions: This study suggests superior efficacy of an accelerated CXL protocol coupled with systemic oxygen supplementation when compared with the accelerated CXL protocol and the conventional protocol in eyes with progressive KC. In addition to greater reduction in Kmax as the primary outcome, improvement in corneal biomechanics was also observed at 6 months.

Trial registration: ClinicalTrials.gov NCT04343326.