Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

A Study to Investigate the Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism

This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperopia
• Intervention / Treatment: Device: TENEO 317 Model 2 excimer laser

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

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92660
      • Site 113
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Site 111
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Site 101
    • Saint Louis Park, Minnesota, United States, 55416
      • Site 104
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Site 103
  • New York
    • Amherst, New York, United States, 14228
      • Site 102
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Site 112
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Site 108
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Site 106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects 22 years of age or older at the time of the pre-operative examination.
2. Manifest, distance corrected visual acuity (CDVA) 20/25 (logMAR 0.10) or better in an operative eye
3. Pre-operative refractive error of hyperopia with spherical component of 0.00 D to +4.00 D with or without cylinder up to +2.00 D, with MRSE of ≥ 0.375 D and ≤ +5.00 D based on the manifest refraction in thestudy eye(s). This would exclude eyes with cylinder-only corrections < +0.75D and sphere-only corrections < +0.375D)
4. Difficulty maintaining uncorrected distance visual acuity (UDVA) of 20/40 or better, as evidenced by need for constant contact lens or spectacle wear.
5. Difference between manifest refractive and cycloplegic spherical equivalent ≤ 0.75 D, difference between manifest and cycloplegic cylinder ≤ ± 0.50 D and difference between manifest and cycloplegic cylinder axis ≤ ± 15 degrees.
6. Stable refraction (i.e., a change of ≤ ± 0.50 D in MRSE) for a minimum of 12 months prior to surgery, as verified by consecutive refractions, medical records, or prescription history.
7. Agree to discontinue use of contact lenses for at least 2 weeks (for rigid or toric lenses) or 3 days (for soft contact lenses) prior to the first refraction used to establish stability and through the day of surgery.
8. All contact lens wearers must demonstrate a stable refraction in an eye to be treated, as follows: two consecutive examinations at least 1 week apart within ± 0.50 D manifest refractive spherical equivalent and within ± 15 degrees cylinder axis.
9. Agree to emmetropia correction for each treated eye.
10. Anticipated postoperative stromal bed thickness of at least 250 microns.
11. Can lie flat without difficulty.
12. Willing and able to read, understand, and sign a written informed consent form (ICF).
13. Willing and able to comply with the schedule for all post-surgery follow-up visits.

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 disease, cataract, glaucoma, immuno-compromised, 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 by any administration route 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, other than hyperopia with or without astigmatism that may predispose the subject to future complications including but not limited to:

   1. Evidence or history of retinal vascular disease
   2. Evidence or history of active or inactive corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.
   3. Evidence or history of glaucoma or glaucoma suspect (IOP > 24mmHg) by exam findings and/or family history
4. Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the outcome of the study or increase the risk to the subject.
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 LASIK procedure and postoperative care).
7. Have central corneal scars affecting visual acuity.
8. Have mixed astigmatism.
9. Presence of keratoconus, keratoconus suspect, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism) or abnormal corneal topography
10. Presence of visually significant or progressive cataract in an eye considered for eligibility.
11. Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).
12. Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.
13. Pregnant, lactating, or subjects who plan to become pregnant during the course of the study.
14. Are participating in any other trial within 30 days of screening or during this clinical trial.
15. Eyes with mesopic pupil size > 7.0 mm.
16. Have a Schirmer's pre-operative test without anesthesia < 4 mm after 5 minutes

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 use for refractive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability	Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 0.50 Diopter of intended correction at the time of refractive stability	Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 1.00 Diopter of intended correction at the time of refractive stability	Up to 12 months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Rosangela Nolasco, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: 906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No