Refractive Transepithelial Photo-keratectomy (T-PKR) in High Myopia (TEPEHERKAHM)

Centre Hospitalier Régional Metz-Thionville

Status: Completed

Conditions: Myopia; Ophthalmopathy; Keratopathy

Study type: Observational

Funder types: Other

Identifiers

NCT04917562

2021-03-Obs-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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