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Completed

NCT Number: NCT04917562

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

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.

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Key information

Conditions

Ophthalmopathy Corneal Diseases Corneal Opacity Eye Diseases Keratopathy Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Metz Thionville

Metz, 57085, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative uncorrected visual acuity (UCVA) at week 1

    Time frame: Week 1

    Postoperative uncorrected visual acuity (UCVA) (logMAR)

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

    Time frame: Week 1

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

  3. Postoperative uncorrected visual acuity (UCVA) at month 1

    Time frame: Month 1

    Postoperative uncorrected visual acuity (UCVA) (logMAR)

  4. Postoperative uncorrected visual acuity (UCVA) at month 3

    Time frame: Month 3

    Postoperative uncorrected visual acuity (UCVA) (logMAR)

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

    Time frame: Month 1

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

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

    Time frame: Month 3

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

Secondary outcomes

  1. Visual acuity efficacy index

    Time frame: 3 months

    The efficacy of the procedure was defined by the proportion of eyes with uncorrected visual acuity at 3 months greater than or equal to Log MAR 0.1 (or 8/10 on a decimal scale). The efficacy index was defined as the ratio between the mean uncorrected visual acuity at 3 months and the best corrected visual acuity preoperatively. A threshold of 80% was required to consider the surgery successful.

  2. Visual acuity safety index

    Time frame: 3 months

    The safety of the procedure was defined as the proportion of eyes that lost 2 or more lines of visual acuity compared to the best preoperative corrected visual acuity.

    The safety index was defined as the ratio between the best corrected visual acuity 3 months postoperatively and the best corrected visual acuity preoperatively. An 80% threshold was chosen to consider the procedure safe.

  3. Predictability

    Time frame: 3 months

    Predictability was defined as the percentage of eyes having reached target refraction (± 0.5D) at the end of follow-up (3 months).

  4. Postoperative corneal haze measurement at week 1

    Time frame: Week1

    Corneal haze assessment was performed at each follow-up visit and reported on the Fantes scale

    • Grade 0: absence of corneal haze.
    • Grade 1: corneal fog that does not prevent the visibility of details of the iris
    • Grade 2: slight fading of details of the iris
    • Grade 3: pronounced erasure of details of the iris and lens
    • Grade 4: complete opacification of the stroma preventing access to the anterior chamber

  5. Postoperative corneal haze measurement at month 1

    Time frame: Month 1

    Corneal haze assessment was performed at each follow-up visit and reported on the Fantes scale

    • Grade 0: absence of corneal haze.
    • Grade 1: corneal fog that does not prevent the visibility of details of the iris
    • Grade 2: slight fading of details of the iris
    • Grade 3: pronounced erasure of details of the iris and lens
    • Grade 4: complete opacification of the stroma preventing access to the anterior chamber

  6. Postoperative corneal haze measurement at month 3

    Time frame: Month 3

    Corneal haze assessment was performed at each follow-up visit and reported on the Fantes scale

    • Grade 0: absence of corneal haze.
    • Grade 1: corneal fog that does not prevent the visibility of details of the iris
    • Grade 2: slight fading of details of the iris
    • Grade 3: pronounced erasure of details of the iris and lens
    • Grade 4: complete opacification of the stroma preventing access to the anterior chamber

  7. postoperative spherical equivalent

    Time frame: 3 months

    Percent of postoperative spherical equivalent D (SD)

  8. Postoperative refractive astigmatism at +/- 0.5D of target

    Time frame: 3 months

    Percent of eyes within +/- 0.5D of target

  9. Postoperative refractive astigmatism at +/- 1.0D of target

    Time frame: 3 months

    Percent of eyes within +/- 1.0D of target

  10. Complications

    Time frame: Up to 3 months

    Percent of postoperative infections or epithelial healing

  11. Patient sex

    Time frame: Before surgery

    Sex ratio Men/Women (percent)

  12. Patient age

    Time frame: Before surgery

    Age (years)

  13. Preoperative Myopia

    Time frame: Before surgery

    Myopia (Diopters)

  14. Preoperative Astigmatism

    Time frame: Before surgery

    Astigmatism (Diopters)

  15. Preoperative Spherical equivalence

    Time frame: Before surgery

    Spherical equivalence (Diopters)

  16. Preoperative best spectacle corrected visual acuity

    Time frame: Before surgery

    BSCVA (logMAR)

  17. Preoperative Keratometry

    Time frame: Before surgery

    Keratometry (dipoters)

  18. Preoperative central corneal thickness

    Time frame: Before surgery

    central corneal thickness (µm)

  19. Preoperative optical and transition zones

    Time frame: Before surgery

    Optical and transition zones (mm)

  20. Preoperative total ablation thickness

    Time frame: Before surgery

    Total ablation thickness (µm)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Refractive Transepithelial Photo-keratectomy (T-PKR) Without Addition of Mitomycin-C in High Myopia: a Retrospective Study of 69 Eyes

Acronym: TEPEHERKAHM

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2021
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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