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

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.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Procedure: Transepithelial Photorefractive keratectomy (tPRK) without laser polishing; Procedure: Transepithelial Photorefractive keratectomy (tPRK) with laser polishing; Procedure: Standard Photorefractive keratectomy (PRK)

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Makati City, Philippines
    • Asian Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ametropia
• Myopic subjects with refractive spherical equivalent (MRSE) between -1.5D and -9.0D
• Hyperopic subjects with refractive spherical equivalent (MRSE) between +1.5D and +5.25D
• Signed informed consent form

Exclusion Criteria:

• Ocular comorbidity
• Subject taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
• Subjects who are known to be pregnant, lactating, or who plans to become pregnant over the medications used for standard tPRK.
• Subjects participating in any other ophthalmic clinical trial during this clinical study.
• Subjects with cognitive impairments or other vulnerable persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transepithelial Photorefractive keratectomy (tPRK) without laser polishing	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.
EXPERIMENTAL: Transepithelial Photorefractive keratectomy (tPRK) with laser polishing	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.
ACTIVE_COMPARATOR: Standard Photorefractive keratectomy (PRK)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute refractive predictability	Absolute refractive predictability is the absolute difference between intended and achieved Manifest Refraction Spherical Equivalent (MRSE) between eyes	3 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.	3 months follow up
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under mesopic light conditions.	3 months follow up
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.	3 months follow up
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under mesopic light conditions. Corrected means spectacle corrected.	3 months follow up
Monocular Contrast Sensitivity	The contrast sensitivity test consists in assessing the possibility to distinguish the alternation of white and grey fringes of difference contrast with difference frequency. Contrast sensitivity will be assessed under photopic and mesopic light conditions using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) device at 2.5 m.	3 months follow up
Halo Photic phenomena	The amount and disturbance of photic halo side effects will be assessed by the Halo Simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of halo. The simulator utilizes a numerical scale to quantify the size and intensity of halos, ranging from 0 (none), 25 (mild), 50 (moderate), 75 (severe) to 100 (very severe).	3 months follow up
Glare Photic phenomena	The amount and disturbance of photic glare side effects will be assessed by the Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare. The simulator utilizes a numerical scale to quantify the size and intensity of glare, ranging from 0 (none), 25 (mild), 50 (moderate), 75 (severe) to 100 (very severe).	3 months follow up
Corneal pain	The epithelial healing process after photorefractive keratectomy treatment often comes along with the perception of some corneal pain. To assess the pain level, the participants will receive a self-administered pain questionnaire to fill out every day from the day of the surgery until they return for the 6-9 days follow up visit. An 11-point scale will be used to rate the self-reporting of pain, where 0 is 'None' and 10 is the highest level of 'Severe'. Higher scores indicate higher level of pain.	3 months follow up
Visual perception scale	To assess the visual perception level, the participants will receive a self-administered visual perception questionnaire to fill out every day from the day of the surgery until they return for the 6-9 days follow up visit. A 4-point scale will be used to rate the self-reporting of visual perception, with 1 = 'Clear' and 4 = 'Very Poor' vision. Higher scores indicate poorer visual perception.	3 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute refractive predictability	Absolute refractive predictability is the absolute difference between intended and achieved Manifest Refraction Spherical Equivalent (MRSE) between eyes	6 months follow up
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.	6 months follow up
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under mesopic light conditions.	6 months follow up
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m, 80 cm and 40 cm in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.	6 months follow up
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m, 80 cm and 40 cm in LogMAR scale under mesopic light conditions. Corrected means spectacle corrected.	6 months follow up
Halo Photic phenomena	The amount and disturbance of photic halo side effects will be assessed by the Halo Simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of halo. The simulator utilizes a numerical scale to quantify the size and intensity of halos, ranging from 0 (none), 25 (mild), 50 (moderate), 75 (severe) to 100 (very severe).	6 months follow up
Glare Photic phenomena	The amount and disturbance of photic glare side effects will be assessed by the Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare. The simulator utilizes a numerical scale to quantify the size and intensity of glare, ranging from 0 (none), 25 (mild), 50 (moderate), 75 (severe) to 100 (very severe).	6 months follow up
Corneal pain	The epithelial healing process after photorefractive keratectomy treatment often comes along with the perception of some corneal pain. To assess the pain level, the participants will receive a self-administered pain questionnaire to fill out every day from the day of the surgery until they return for the 6-9 days follow up visit. An 11-point scale will be used to rate the self-reporting of pain. Higher scores indicate higher level of pain, where 0 is 'None' and 10 is the highest level of 'Severe'. Higher scores indicate higher level of pain.	6 months follow up
Visual perception scale	To assess the visual perception level, the participants will receive a self-administered visual perception questionnaire to fill out every day from the day of the surgery until they return for the 6-9 days follow up visit. A 4-point scale will be used to rate the self-reporting of visual perception, with 1 = 'Clear' and 4 = 'Very Poor' vision. Higher scores indicate poorer visual perception.	6 months follow up

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2021
• Primary Completion (ACTUAL): March 21, 2022
• Study Completion (ACTUAL): March 21, 2022

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (ACTUAL): January 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: BL1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No