Base curves of bandage contact lenses and their effects on post Trans-PRK vision and pain: the study protocol for a randomized clinical trial.

Abstract

Background: Transepithelial photorefractive keratectomy (Trans-PRK) is an effective and safe laser surgery for myopia. Following this procedure, a bandage contact lens is used to promote epithelial healing, reduce postoperative pain, and improve visual recovery. The base curve of these lenses may affect vision post-surgery, particularly in patients with steep corneas and high myopia. This study aims to investigate the impact of using bandage contact lenses with base curves of 8.4 mm versus 8.8 mm on visual recovery after Trans-PRK in patients with steep corneas and high myopia.

Methods: This is a randomized, double-blind, binocularly controlled, single-center trial. The study subjects are myopic patients scheduled for Trans-PRK. Both eyes in each patient will be treated consecutively with single-step Trans-PRK. After surgery, a contact lens with an 8.8-mm base curve will be placed on one eye, and a lens with an 8.4-mm base curve will be placed on the other. The primary objective is to determine the difference in early postoperative uncorrected visual acuity between the two eyes of patients with steep corneas and high myopia. Randomization will be conducted using a computer-generated random allocation sequence without blocks or restrictions. The sequence will be recorded in sealed opaque envelopes, maintained by the principal investigator until the trial's conclusion. In this double-masked trial, subjects will not know which treatment each eye receives.

Discussion: This novel trial will provide information on how bandage contact lenses with different base curves promote epithelial healing and visual recovery after Trans-PRK, thus offering evidence for clinical practice.

Trial registration: ClinicalTrials.gov NCT06393855. Registered on May 1, 2024. https://clinicaltrials.gov/study/NCT06393855 .