CompletedNot Applicable

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

France38 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative uncorrected visual acuity (UCVA) at week 1

Timeframe: Week 1

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

Timeframe: Week 1

Postoperative uncorrected visual acuity (UCVA) at month 1

Timeframe: Month 1

Postoperative uncorrected visual acuity (UCVA) at month 3

Timeframe: Month 3

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

Timeframe: Month 1

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

Timeframe: Month 3

Trial details

NCT IDNCT04917562

SponsorCentre Hospitalier Régional Metz-Thionville

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01-01

View on ClinicalTrials.gov More Ophthalmopathy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Postoperative uncorrected visual acuity (UCVA) at week 1

Timeframe: Week 1

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

Timeframe: Week 1

Postoperative uncorrected visual acuity (UCVA) at month 1

Timeframe: Month 1

Postoperative uncorrected visual acuity (UCVA) at month 3

Timeframe: Month 3

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

Timeframe: Month 1

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

Timeframe: Month 3