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

NCT04917562 | Completed

• 1 other identifier: 2021-03-Obs-CHRMT
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Ophthalmopathy; Myopia; Keratopathy

Keywords

transepithelial photorefractive keratectomy; high myopia; mitomycin-C; corneal haze; efficacy; predictibility

Outcome Measures

Primary Outcomes (6)

• Postoperative uncorrected visual acuity (UCVA) at week 1

  Postoperative uncorrected visual acuity (UCVA) (logMAR)

  Week 1

• Postoperative best spectacle corrected visual acuity (BSCVA) at week 1

  Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR)

  Week 1

• Postoperative uncorrected visual acuity (UCVA) at month 1

  Postoperative uncorrected visual acuity (UCVA) (logMAR)

  Month 1

• Postoperative uncorrected visual acuity (UCVA) at month 3

  Postoperative uncorrected visual acuity (UCVA) (logMAR)

  Month 3

• Postoperative best spectacle corrected visual acuity (BSCVA) at month 1

  Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR)

  Month 1

• Postoperative best spectacle corrected visual acuity (BSCVA) at month 3

  Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR)

  Month 3

Secondary Outcomes (20)

• Visual acuity efficacy index

  3 months

• Visual acuity safety index

  3 months

• Predictability

  3 months

• Postoperative corneal haze measurement at week 1

  Week1

• Postoperative corneal haze measurement at month 1

  Month 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

Centre Hospitalier Metz Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Eye Diseases; Myopia; Corneal Opacity

Condition Hierarchy (Ancestors)

Refractive Errors; Corneal Diseases

Study Officials

• Jean Marc PERONE, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 8, 2021
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 13, 2023

Record last verified: 2021-05

Locations

FR (1)