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 range22 Years

SexALL

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).
✕. Use of medications that may increase risk to the subject or may confound the outcome of the study, including those known to affect wound healing (e.g., systemic corticosteroids, antimetabolites)
✕. Ocular conditions that may predispose the subject to future complications, including but not limited to:
✕. Evidence or history of retinal vascular disease
✕. History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.
✕. History of or evidence of glaucoma or glaucoma suspect (e.g., IOP \> 21 mmHg).
✕. Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the study's outcome or increase the subject's risk.
✕. An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation.

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 range22 Years

SexALL

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).
✕. Use of medications that may increase risk to the subject or may confound the outcome of the study, including those known to affect wound healing (e.g., systemic corticosteroids, antimetabolites)
✕. Ocular conditions that may predispose the subject to future complications, including but not limited to:
✕. Evidence or history of retinal vascular disease
✕. History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.
✕. History of or evidence of glaucoma or glaucoma suspect (e.g., IOP \> 21 mmHg).
✕. Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the study's outcome or increase the subject's risk.
✕. An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation.

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