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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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05264623
Collaborator
(none)
140
Enrollment
9
Locations
1
Arm
15
Anticipated Duration (Months)
15.6
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TENEO 317 Model 2 excimer laser
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  4. Evidence or history of retinal vascular disease

  5. History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.

  6. History of or evidence of glaucoma or glaucoma suspect (IOP > 24 mmHg).

  7. 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.

  8. An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation.

  9. Known sensitivity to any study medications (e.g., used during LASIK procedure and postoperative care).

  10. Have central corneal scars affecting visual acuity.

  11. Presence of keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism).

  12. Presence of visually significant or progressive cataract in an eye considered for eligibility.

  13. Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).

  14. Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.

  15. Pregnant, lactating, or subjects who plan to become pregnant during the course of the study.

  16. Are participating in any other trial within 30 days of screening or during this clinical trial.

  17. Eyes with mesopic pupil size > 7.0 mm.

  18. Have a Schirmer's pre-operative test without anesthesia < 4 mm/5 minutes.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bausch Site 101 Bloomington Minnesota United States 55420
2 Bausch Site 104 Saint Louis Park Minnesota United States 55416
3 Bausch Site 103 Omaha Nebraska United States 68118
4 Bausch Site 105 Portsmouth New Hampshire United States 03801
5 Bausch Site 102 Amherst New York United States 14228
6 Bausch Site 107 Greensboro North Carolina United States 27401
7 Bausch Site 109 Mount Pleasant South Carolina United States 29464
8 Bausch Site 108 Sioux Falls South Dakota United States 57108
9 Bausch Site 106 Cedar Park Texas United States 78613

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Anya Loncaric, Bausch Health Americas, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT05264623
Other Study ID Numbers:
  • 906
First Posted:
Mar 3, 2022
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Astigmatism
Hyperopia

Study Results

No Results Posted as of May 11, 2022