AzTrials
AzTrials

OphthalmopathyTEPEHERKAHMNCT04917562

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

An observational study of Ophthalmopathy and Myopia, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ophthalmopathy, Myopia, Keratopathy
How many people
38 participants
Where
1 siteFrance
Study dates
1 Jan 2018to 1 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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,
Show all 9Show fewer
  • history of eye surgery,
  • active inflammatory or infectious eye disease,
  • dermatological disease or systemic connectivitis

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Metz Thionville

    Metz, 57085

Other trials in France

About this study

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

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.

Read the 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.

Keywords
transepithelial photorefractive keratectomy, high myopia, mitomycin-C, corneal haze, efficacy, predictibility
Medical subject headings
Eye Diseases, Myopia, Corneal Opacity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Postoperative uncorrected visual acuity (UCVA) (logMAR)

    Measured: Week 1

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

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

    Measured: Week 1

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

    Postoperative uncorrected visual acuity (UCVA) (logMAR)

    Measured: Month 1

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

    Postoperative uncorrected visual acuity (UCVA) (logMAR)

    Measured: Month 3

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

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

    Measured: Month 1

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

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

    Measured: Month 3

Secondary outcomes (20)

  1. Visual acuity efficacy index

    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.

    Measured: 3 months

  2. Visual acuity safety index

    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.

    Measured: 3 months

  3. Predictability

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

    Measured: 3 months

  4. Postoperative corneal haze measurement at week 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

    Measured: Week1

  5. Postoperative corneal haze measurement at 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

    Measured: Month 1

  6. Postoperative corneal haze measurement at 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

    Measured: Month 3

  7. postoperative spherical equivalent

    Percent of postoperative spherical equivalent D (SD)

    Measured: 3 months

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

    Percent of eyes within +/- 0.5D of target

    Measured: 3 months

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

    Percent of eyes within +/- 1.0D of target

    Measured: 3 months

  10. Complications

    Percent of postoperative infections or epithelial healing

    Measured: Up to 3 months

  11. Patient sex

    Sex ratio Men/Women (percent)

    Measured: Before surgery

  12. Patient age

    Age (years)

    Measured: Before surgery

  13. Preoperative Myopia

    Myopia (Diopters)

    Measured: Before surgery

  14. Preoperative Astigmatism

    Astigmatism (Diopters)

    Measured: Before surgery

  15. Preoperative Spherical equivalence

    Spherical equivalence (Diopters)

    Measured: Before surgery

  16. Preoperative best spectacle corrected visual acuity

    BSCVA (logMAR)

    Measured: Before surgery

  17. Preoperative Keratometry

    Keratometry (dipoters)

    Measured: Before surgery

  18. Preoperative central corneal thickness

    central corneal thickness (µm)

    Measured: Before surgery

  19. Preoperative optical and transition zones

    Optical and transition zones (mm)

    Measured: Before surgery

  20. Preoperative total ablation thickness

    Total ablation thickness (µm)

    Measured: Before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2021
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04917562
Sponsor's protocol ID
2021-03-Obs-CHRMT
Acronym
TEPEHERKAHM
Status last verified
May 2021
First submitted
21 May 2021
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ophthalmopathy and Myopia, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative uncorrected visual acuity (UCVA) at week 1 (time frame: Week 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04917562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in