Clinical trial NCT04698174: Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
Official title: Prospective Clinical Study to Evaluate the Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute refractive predictability
timeFrame: 3 months follow up
Secondary outcomes:
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 3 months follow up
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
timeFrame: 3 months follow up
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: 3 months follow up
measure: Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
timeFrame: 3 months follow up
measure: Monocular Contrast Sensitivity
timeFrame: 3 months follow up
measure: Halo Photic phenomena
timeFrame: 3 months follow up
measure: Glare Photic phenomena
timeFrame: 3 months follow up
measure: Corneal pain
timeFrame: 3 months follow up
measure: Visual perception scale
timeFrame: 3 months follow up
Other outcomes:
measure: Absolute refractive predictability
timeFrame: 6 months follow up
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 6 months follow up
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
timeFrame: 6 months follow up
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: 6 months follow up
measure: Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
timeFrame: 6 months follow up
measure: Halo Photic phenomena
timeFrame: 6 months follow up
measure: Glare Photic phenomena
timeFrame: 6 months follow up
measure: Corneal pain
timeFrame: 6 months follow up
measure: Visual perception scale
timeFrame: 6 months follow up
Locations:
city: Makati City
country: Philippines
facility: Asian Eye Institute
Study officials:
affiliation: Asian Eye Institute
name: Robert Ang, MD
role: PRINCIPAL_INVESTIGATOR
References: