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

NCT06618547 | Not Yet Recruiting FDA Device

• 1 other identifier: 907
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Maintenance of BCDVA -

  lines lost \<5% of eyes with a loss of \>2 lines of BCDVA at the stability visit

  through study completion, an average of 1 year

• Maintenance of BCDVA -

  preservation 20/40 \<1% of eyes with a BCDVA of 20/20 or better preoperatively that have a BCDVA worse than 20/40 at the stability visit

  through study completion, an average of 1 year

• Induced manifest refractive astigmatism

  \<5% of eyes with induced manifest refractive astigmatism greater \>2 diopters at the stability visit

  through study completion, an average of 1 year

• Induced manifest refractive astigmatism

  \< 1% of eyes with serious adverse events by type of event observed through the final study visit.

  through study completion, an average of 1 year

Study Arms (1)

TENEO 317 Model 2 excimer laser

EXPERIMENTAL

Device: TENEO 317 Model 2 excimer laser

Interventions

TENEO 317 Model 2 excimer laser DEVICE

TENEO 317 Model 2 excimer laser by Transepithelial Photorefractive Keratectomy

TENEO 317 Model 2 excimer laser

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to lie flat without difficulty.
• Willing and able to read, understand, and sign a written informed consent form (ICF)
• Willing and able to comply with the schedule for all post-surgery follow-up visits.
• Pre-operative myopic refractive error with sphere component from -0.25 D to -8.00 D in each operative eye, with or without cylinder from 0.00 D to -3.00 D, based on the manifest refraction with treated MRSE of -0.25 D to -9.50 D.

You may not qualify if:

• 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.
• Known sensitivity to any study medications (e.g., used during TransEpi PRK procedure and postoperative care).
• Central corneal scars affecting visual acuity.
• Presence of keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism).
• Presence of visually significant or progressive cataract in an eye considered for eligibility.
• Actively taking medications contraindicated with TransEpi PRK, such as isotretinoin (Accutane®) or amiodarone hydrochloride (Cordarone®).
• Cardiac pacemaker, implanted defibrillator, or another implanted electronic device.
• Pregnant, lactating, or subjects who plan to become pregnant during the study.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Dennis Carson

CONTACT

4035025307; Dennis.Carson@bausch.com

Rosangela Nolasco

CONTACT

9492591633; Rosangela.Nolasco2@bausch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share