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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: TENEO 317 Model 2 excimer laser

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosangela Nolasco; Phone Number: 9492591633; Email: Rosangela.Nolasco2@bausch.com
• Study Contact Backup: Name: Dennis Carson; Phone Number: 4035025307; Email: dennis.carson@bausch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 22 years of age or older at the time of the pre-operative examination.
2. Best distance corrected visual acuity (BCDVA) 20/25 or better in the study eye
3. Difference between manifest refractive spherical equivalent (MRSE) and the cycloplegic refraction of ≤ 0.75 D in the study eye.
4. 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.
5. 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.
6. 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.
7. Normal corneal topography per the investigator in the study eye.
8. Anticipated postoperative stromal thickness of at least 350 microns.
9. Ability to lie flat without difficulty.
10. Willing and able to read, understand, and sign a written informed consent form (ICF)
11. Willing and able to comply with the schedule for all post-surgery follow-up visits.
12. 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.

Exclusion Criteria:

1. 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).
2. 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)

3. Ocular conditions that may predispose the subject to future complications, including but not limited to:

   1. Evidence or history of retinal vascular disease
   2. History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.
   3. History of or evidence of glaucoma or glaucoma suspect (e.g., IOP > 21 mmHg).
4. Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the study's outcome or increase the subject's risk.
5. An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation.
6. Known sensitivity to any study medications (e.g., used during TransEpi PRK procedure and postoperative care).
7. Central corneal scars affecting visual acuity.
8. Presence of keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism).
9. Presence of visually significant or progressive cataract in an eye considered for eligibility.
10. Actively taking medications contraindicated with TransEpi PRK, such as isotretinoin (Accutane®) or amiodarone hydrochloride (Cordarone®).
11. Cardiac pacemaker, implanted defibrillator, or another implanted electronic device.
12. Pregnant, lactating, or subjects who plan to become pregnant during the study.
13. Participation in any other clinical trial within 30 days of screening or during this clinical trial.14. Subjects for whom the pre-operative assessment of the cornea/ eyes indicates that one or both eyes are not suitable candidates for treatment based upon the investigator's medical judgment.

15. Treated eye with mesopic pupil size > 7.0 mm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENEO 317 Model 2 excimer laser	Device: TENEO 317 Model 2 excimer laser; TENEO 317 Model 2 excimer laser by Transepithelial Photorefractive Keratectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism
• Other Study ID Numbers: 907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes