Clinical trial NCT04917562: Refractive Transepithelial Photo-keratectomy (T-PKR) in High Myopia
Official title: Refractive Transepithelial Photo-keratectomy (T-PKR) Without Addition of Mitomycin-C in High Myopia: a Retrospective Study of 69 Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmopathy
Myopia
Keratopathy
Keywords: transepithelial photorefractive keratectomy
high myopia
mitomycin-C
corneal haze
efficacy
predictibility
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective study conducted on the eyes of patients with high myopia (less than or equal to -6 diopters) associated or not with astigmatic less than 3 diopters operated by Trans-PRK with the SCHWIND Amaris 500E platform (SCHWIND eye-tech-solutions GmbH, Kleinostheim, Germany) in the CHR Metz-Thionville between January 1, 2018 and January 1, 2020

Brief summary: The aim of this study is to evaluate the anatomical and refractive parameters following a single-step transepithelial photo-refractive keratectomy (T-PRK) without the addition of mitomycin-C for the treatment of high myopia of 6 diopters or more.

Detailed description: In this retrospective study, 69 high myopic eyes of 6 diopters or more were treated in 38 patients by Trans-PRK with the SCHWIND Amaris 500E® excimer laser platform without the use of mitomycin-C. Several outcomes are measured in treated patients, such as postoperative uncorrected visual acuity (UCVA), best spectacle corrected visual acuity (BSCVA), efficacy, safety and predictability of the procedure, as well as corneal haze measurement. The patients are followed-up for 3 months.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years,
* myopic sphere of -6 diopters or more,
* astigmatism less than 3 diopters,
* stable myopia not progressing for more than one year

Exclusion Criteria:

* age \<18 years,
* myopic sphere less than -6 diopters,
* astigmatism greater than 3 diopters,
* progressive myopia (variation of more than 0.5 diopters over one year),
* abnormal corneal topography or the presence of manifest keratoconus,
* pre-existing eye pathology,
* history of eye surgery,
* active inflammatory or infectious eye disease,
* dermatological disease or systemic connectivitis

Primary outcomes:
measure: Postoperative uncorrected visual acuity (UCVA) at week 1
timeFrame: Week 1
measure: Postoperative best spectacle corrected visual acuity (BSCVA) at week 1
timeFrame: Week 1
measure: Postoperative uncorrected visual acuity (UCVA) at month 1
timeFrame: Month 1
measure: Postoperative uncorrected visual acuity (UCVA) at month 3
timeFrame: Month 3
measure: Postoperative best spectacle corrected visual acuity (BSCVA) at month 1
timeFrame: Month 1
measure: Postoperative best spectacle corrected visual acuity (BSCVA) at month 3
timeFrame: Month 3
Secondary outcomes:
measure: Visual acuity efficacy index
timeFrame: 3 months
measure: Visual acuity safety index
timeFrame: 3 months
measure: Predictability
timeFrame: 3 months
measure: Postoperative corneal haze measurement at week 1
timeFrame: Week1
measure: Postoperative corneal haze measurement at month 1
timeFrame: Month 1
measure: Postoperative corneal haze measurement at month 3
timeFrame: Month 3
measure: postoperative spherical equivalent
timeFrame: 3 months
measure: Postoperative refractive astigmatism at +/- 0.5D of target
timeFrame: 3 months
measure: Postoperative refractive astigmatism at +/- 1.0D of target
timeFrame: 3 months
measure: Complications
timeFrame: Up to 3 months
measure: Patient sex
timeFrame: Before surgery
measure: Patient age
timeFrame: Before surgery
measure: Preoperative Myopia
timeFrame: Before surgery
measure: Preoperative Astigmatism
timeFrame: Before surgery
measure: Preoperative Spherical equivalence
timeFrame: Before surgery
measure: Preoperative best spectacle corrected visual acuity
timeFrame: Before surgery
measure: Preoperative Keratometry
timeFrame: Before surgery
measure: Preoperative central corneal thickness
timeFrame: Before surgery
measure: Preoperative optical and transition zones
timeFrame: Before surgery
measure: Preoperative total ablation thickness
timeFrame: Before surgery
Other outcomes:
Locations:
city: Metz
country: France
facility: Centre Hospitalier Metz Thionville
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Jean Marc PERONE, MD
role: PRINCIPAL_INVESTIGATOR
References: