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: Recruiting
• Conditions: Hyperopia
• Intervention / Treatment: Device: TENEO 317 Model 2 excimer laser

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

Contacts and Locations

• Study Contact: Name: Anya Loncaric; Phone Number: (310) 770-7750; Email: Anya.Loncaric@bauschcloud.com

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Recruiting
      • Bausch Site 101
    • Saint Louis Park, Minnesota, United States, 55416
      • Recruiting
      • Bausch Site 104
  • Nebraska
    • Omaha, Nebraska, United States, 68118
      • Not yet recruiting
      • Bausch Site 103
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Not yet recruiting
      • Bausch Site 105
  • New York
    • Amherst, New York, United States, 14228
      • Recruiting
      • Bausch Site 102
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Not yet recruiting
      • Bausch Site 107
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Not yet recruiting
      • Bausch Site 109
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Bausch Site 108
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Recruiting
      • Bausch 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 best spectacle corrected visual acuity (BSCVA) 20/25 (logMAR 0.10) or better in an operative eye
3. Pre-operative refractive error of hyperopia with spherical component of +1.00 D to +4.00 D with or without cylinder up to +2.00 D, based on the manifest refraction in the study eye(s).
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 spherical equivalent (MRSE) and the cycloplegic refraction of < 0.75 D
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. A stable refraction (within ± 0.50 D) after discontinuation of contact lens, as determined by MRSE between the first refraction used to establish stability and through the day of surgery and a subsequent examination at least 1 week apart.
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., inadequately controlled 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. 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 (IOP > 24 mmHg).
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. 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 LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).
11. Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.
12. Pregnant, lactating, or subjects who plan to become pregnant during the course of the study.
13. Are participating in any other trial within 30 days of screening or during this clinical trial.
14. Eyes with mesopic pupil size > 7.0 mm.
15. Have a Schirmer's pre-operative test without anesthesia < 4 mm/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
Percentage of eyes that achieve predictability of Manifest Refractive Spherical Equivalent (MRSE) (attempted versus achieved) within ± 0.50 Diopter at the time of refractive stability	Up to 12 months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Anya Loncaric, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): May 29, 2025
• Study Completion (Estimated): May 29, 2025

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): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; 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