NCT04698174

Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

Prospective Clinical Study to Evaluate the Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, comparative, randomized, controlled, single-blind, single-surgeon, single-center PMCF clinical study whereby participants undergoing refractive surgery for correction of ametropia will receive a transepithelial PRK (tPRK) and conventional PRK treatment in the contralateral eye. To avoid bias in the clinical outcomes, the two PRK treatment options are randomized to the eyes of the patients based on ocular dominance. In addition, a 1:1 randomization is applied within the tPRK group to eyes with and without end-treatment laser polishing. Both procedures, standard PRK and tPRK, are performed in a one-step procedure. The main difference between the procedures is, that in conventional PRK, the epithelium will be removed using alcohol, whereas in tPRK procedures, the epithelium will be removed by laser ablation.

Conditions

• Ametropia

Interventions

Type	Name	Description
PROCEDURE	Transepithelial Photorefractive keratectomy (tPRK) without laser polishing	Transepithelial Photorefractive keratectomy (tPRK) with laser ablation of the corneal epithelium and stroma in a single-step procedure using the B+L Teneo 317 Model 2 Excimer Laser.
PROCEDURE	Transepithelial Photorefractive keratectomy (tPRK) with laser polishing	Transepithelial Photorefractive keratectomy (tPRK) using the B+L Teneo 317 Model 2 Excimer Laser with end-treatment laser polishing using a fixed thickness of the additional layer of 5 μm.
PROCEDURE	Standard Photorefractive keratectomy (PRK)	Conventional Photorefractive keratectomy (PRK) with alcohol-assisted epithelium ablation. Then the aspheric ablation profile will be performed using the B+L Teneo 317 Model 2 Excimer Laser.

Timeline

• Start date: 2021-02-02
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2021-01-06
• Last updated: 2022-10-07

Locations

1 site across 1 country: Philippines