Not Yet RecruitingNot Applicable

Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia With or Without Astigmatism by Transepithelial Photorefractive Keratectomy

140 participantsStarted 2025-11

Plain-language summary

A Study to Investigate the Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia with or without Astigmatism by Transepithelial Photorefractive Keratectomy

Who can participate

Age range

22 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

. 22 years of age or older at the time of the pre-operative examination.
. Best distance corrected visual acuity (BCDVA) 20/25 or better in the study eye
. Difference between manifest refractive spherical equivalent (MRSE) and the cycloplegic refraction of ≤ 0.75 D in the study eye.
. Stable refraction (i.e., a change of ≤ 0.50 D in MRSE) for a minimum of 12 months before surgery, as verified by consecutive refractions, medical records, or prescription history.
. Agree to discontinue contact lenses for at least two weeks (for rigid or toric lenses) or three days (for soft contact lenses) before the first refraction to establish stability and through the day of surgery.
. A stable refraction (within ± 0.50 D) after discontinuation of contact lens(es), as determined by MRSE between two consecutive examinations at least one week apart.
. Normal corneal topography per the investigator in the study eye.
. Anticipated postoperative stromal thickness of at least 350 microns.

Exclusion criteria

. Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye, cataract, immuno-compromise, rheumatoid arthritis, clinically significant atopic disease, acne rosacea, autoimmune disease, endocrine disorders, lupus, systemic connective tissue disease, diabetes, or severe atopic disease).

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

Maintenance of BCDVA -

Timeframe: through study completion, an average of 1 year

Maintenance of BCDVA -

Timeframe: through study completion, an average of 1 year

Induced manifest refractive astigmatism

Timeframe: through study completion, an average of 1 year

Induced manifest refractive astigmatism

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT06618547

SponsorBausch & Lomb Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Dennis Carson

4035025307 Dennis.Carson@bausch.com

View on ClinicalTrials.gov More Myopia trials

Who can participate

Age range

22 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

. 22 years of age or older at the time of the pre-operative examination.
. Best distance corrected visual acuity (BCDVA) 20/25 or better in the study eye
. Difference between manifest refractive spherical equivalent (MRSE) and the cycloplegic refraction of ≤ 0.75 D in the study eye.
. Stable refraction (i.e., a change of ≤ 0.50 D in MRSE) for a minimum of 12 months before surgery, as verified by consecutive refractions, medical records, or prescription history.
. Agree to discontinue contact lenses for at least two weeks (for rigid or toric lenses) or three days (for soft contact lenses) before the first refraction to establish stability and through the day of surgery.
. A stable refraction (within ± 0.50 D) after discontinuation of contact lens(es), as determined by MRSE between two consecutive examinations at least one week apart.
. Normal corneal topography per the investigator in the study eye.
. Anticipated postoperative stromal thickness of at least 350 microns.

Exclusion criteria

. Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye, cataract, immuno-compromise, rheumatoid arthritis, clinically significant atopic disease, acne rosacea, autoimmune disease, endocrine disorders, lupus, systemic connective tissue disease, diabetes, or severe atopic disease).

What they're measuring

Maintenance of BCDVA -

Timeframe: through study completion, an average of 1 year

Maintenance of BCDVA -

Timeframe: through study completion, an average of 1 year

Induced manifest refractive astigmatism

Timeframe: through study completion, an average of 1 year

Induced manifest refractive astigmatism

Timeframe: through study completion, an average of 1 year