A Comparative Study Between Laser and Manual Removal of Corneal Epithelium for Photorefractive Ke… (NCT06748599) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Comparative Study Between Laser and Manual Removal of Corneal Epithelium for Photorefractive Keratectomy
64 participantsStarted 2025-01-01
Plain-language summary
Photorefractive keratectomy (PRK) is a laser eye surgery used to ablate the corneal stroma to correct visual refractive errors . PRK was developed in 1983 by Dr. Steven Trokel and colleagues and first performed in 1987 by Dr. Theo Seiler in Berlin. After receiving approval by the US Food and Drug Administration (FDA) in 1996, PRK was briefly the preferred surgical treatment of ametropia as it provided more predictable and stable results than incisional keratotomy. However, the number of PRK procedures fell in the late 1990s with the growing popularity of laser in situ keratomileusis (LASIK).
The study aims to compare the visual and refractive outcomes along with the pain score and patient satisfaction after photorefractive keratectomy in patients who underwent transepithelial or mechanical removal technique
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 : older than 18 years old .
* Gender: Include both males and females.
* Stable refraction for at least 12 months .
* Intraocular pressure less than 21mmHg.
* A period without wearing contact lenses (more than 4 days for soft , more than 2 weeks for rigid contact lenses )
* No history of any Autoimmune disease .
* The refractive error must be one that can be treated by PRK
Exclusion Criteria:
* \_ patients with any eye disease (significant cataract or unstable glaucoma )
* uncontrolled external disease such as blepharitis, dry eye syndrome, and atopy/allergy.
* patients with Keratoconus and other abnormalities of the cornea such as corneal ectasias , thinning , edema , interstitial or neurotrophic keratitis and extensive vascularisation .
* Patients with active systemic connective tissue disease such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA)
* Ineligibility for Surgery: Exclude patients who are not suitable candidates for surgery .
* Consider excluding pregnant or lactating women .
* Patients unwilling to participate in the study .
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.