Using a new excimer laser for LASIK surgery to treat farsightedness

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 study is testing a new excimer laser for LASIK surgery to see if it can safely and effectively treat farsightedness in people aged 22 and older.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Bausch & Lomb Incorporated (industry)
• Locations: 12 sites (Newport Beach, California and 11 other locations)
• Trial ID: NCT05264623 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, open-label study evaluates the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 excimer laser in LASIK surgery for treating hyperopia, with or without astigmatism. Participants aged 22 and older will undergo the procedure, and both eyes may be treated if they meet the eligibility criteria. The study will assess the primary effectiveness endpoint at the point of refractive stability over a 12-month period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with specific levels of hyperopia and astigmatism who struggle with maintaining clear distance vision.

Not a fit: Patients with severe refractive errors outside the specified range or those with unstable refraction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from hyperopia and improve their visual acuity.

How similar studies have performed: Other studies have shown success with similar laser technologies in treating refractive errors, indicating a promising approach.

Eligibility criteria

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 +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 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 \> 24 mmHg) 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. Presence of keratoconus, keratoconus suspect, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism) or abnormal corneal topography
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 after 5 minutes.

Where this trial is running

Newport Beach, California and 11 other locations

• Site 113 — Newport Beach, California, United States (RECRUITING)
• Site 111 — Fort Myers, Florida, United States (RECRUITING)
• Bausch Site 101 — Bloomington, Minnesota, United States (RECRUITING)
• Bausch Site 104 — Saint Louis Park, Minnesota, United States (RECRUITING)
• Bausch Site 103 — Omaha, Nebraska, United States (RECRUITING)
• Bausch Site 105 — Portsmouth, New Hampshire, United States (NOT_YET_RECRUITING)
• Bausch Site 102 — Amherst, New York, United States (RECRUITING)
• Bausch Site 107 — Greensboro, North Carolina, United States (NOT_YET_RECRUITING)
• Site 112 — Pittsburgh, Pennsylvania, United States (RECRUITING)
• Bausch Site 109 — Mount Pleasant, South Carolina, United States (NOT_YET_RECRUITING)
• Bausch Site 108 — Sioux Falls, South Dakota, United States (RECRUITING)
• Bausch Site 106 — Cedar Park, Texas, United States (COMPLETED)

Study contacts

• Study coordinator: Dennis Carson

Conditions: Hyperopia