Purpose: To report the intraoperative and postoperative complications and to evaluate the outcomes of femtosecond laser-assisted pocket implantation of 360-degree MyoRing® versus tunnel implantation of 340-degree Keraring® for the management of central keratoconus.
Methods: This prospective randomized comparative interventional study included 74 eyes of 74 patients with central keratoconus stratified according to the surgical approach into corneal pocket (n =37) and corneal tunnel groups (n =37) who underwent WaveLight® FS200 femtosecond laser-assisted implantation of 360-degree MyoRing® and 340-degree Keraring®, respectively. The main outcome measures were the intraoperative complications encountered during surgery, and the postoperative complications reported over 12 months of follow-up. The 12-month visual, refractive and tomographic outcomes were also evaluated.
Results: The baseline characteristics were similar between both groups. The intraoperative complications included incomplete pocket formation (3 eyes; 8.1%) and limbal bleeding (4 eyes; 10.8%) in the corneal pocket group and channel decentration in the tunnel group (2 eyes; 5.4%). Interface central haze (5 eyes; 13.5%) was the most common postoperative complication following pocket implantation of MyoRing®. Infectious keratitis developed in 2 eyes (5.4%) following pocket implantation of MyoRing® and in one eye (2.7%) following tunnel implantation of 340-degree Keraring®. The mean uncorrected & corrected distance visual acuity and spherical equivalent showed significant improvement as a result of significant corneal flattening at 12 months postoperatively in both groups.
Conclusions: The rate of both intraoperative and postoperative complications was higher, but didn't reach statistical significance, in femtosecond laser-assisted corneal pocket implantation of 360-degree MyoRing® versus tunnel implantation of 340-degree Keraring® for central keratoconus. Avoiding surgical manipulation of the central cornea and visual axis enhances the safety of the procedure in the tunnel surgical approach. The visual, refractive and tomographic outcomes showed significant and comparable improvements following the implantation of both ring implants.
Trial registration: ClinicalTrials.gov: NCT05748847, 1 March 2023, retrospectively registered, https://clinicaltrials.gov/study/NCT05748847.
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