Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Procedure: Standard Photorefractive keratectomy (PRK); Procedure: Transepithelial Photorefractive keratectomy (tPRK) without laser polishing; Procedure: Transepithelial Photorefractive keratectomy (tPRK) with laser polishing

• Registration Number: NCT04698174
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Study Start: 2021-02-02
• Status Verified: 2022-03
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Photorefractive keratectomy (PRK)	Standard Photorefractive keratectomy (PRK)	-
Transepithelial Photorefractive keratectomy (tPRK) without laser polishing	Transepithelial Photorefractive keratectomy (tPRK) without laser polishing	-
Transepithelial Photorefractive keratectomy (tPRK) with laser polishing	Transepithelial Photorefractive keratectomy (tPRK) with laser polishing	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions	3 months follow up	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.
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions	3 months follow up	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.
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions	3 months follow up	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.
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions	3 months follow up	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.
Halo Photic phenomena	3 months follow up	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).
Glare Photic phenomena	3 months follow up	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).
Monocular Contrast Sensitivity	3 months follow up	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.
Visual perception scale	3 months follow up	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.
Corneal pain	3 months follow up	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.

Trial Locations

Locations (1)

Asian Eye Institute; 🇵🇭 Makati City, Philippines