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

Not Applicable

Recruiting

• Conditions: Hyperopia

• Registration Number: NCT05264623
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-2-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subjects 22 years of age or older at the time of the pre-operative examination.<br><br> 2. Manifest, distance corrected visual acuity (CDVA) 20/25 (logMAR 0.10) or better in<br> an operative eye<br><br> 3. Pre-operative refractive error of hyperopia with spherical component of +1.00 D to<br> +4.00 D with or without cylinder up to +2.00 D, based on the manifest refraction in<br> the study eye(s).<br><br> 4. Difficulty maintaining uncorrected distance visual acuity (UDVA) of 20/40 or better,<br> as evidenced by need for constant contact lens or spectacle wear.<br><br> 5. Difference between manifest refractive and cycloplegic spherical equivalent = 0.75<br> D, difference between manifest and cycloplegic cylinder = ± 0.50 D and difference<br> between manifest and cycloplegic cylinder axis = ± 15 degrees.<br><br> 6. Stable refraction (i.e., a change of = ± 0.50 D in MRSE) for a minimum of 12 months<br> prior to surgery, as verified by consecutive refractions, medical records, or<br> prescription history.<br><br> 7. Agree to discontinue use of contact lenses for at least 2 weeks (for rigid or toric<br> lenses) or 3 days (for soft contact lenses) prior to the first refraction used to<br> establish stability and through the day of surgery.<br><br> 8. All contact lens wearers must demonstrate a stable refraction in an eye to be<br> treated, as follows: two consecutive examinations at least 1 week apart within ±<br> 0.50 D manifest refractive spherical equivalent and within ± 15 degrees cylinder<br> axis.<br><br> 9. Agree to emmetropia correction for each treated eye.<br><br> 10. Anticipated postoperative stromal bed thickness of at least 250 microns.<br><br> 11. Can lie flat without difficulty.<br><br> 12. Willing and able to read, understand, and sign a written informed consent form<br> (ICF).<br><br> 13. Willing and able to comply with the schedule for all post-surgery follow-up visits.<br><br>Exclusion Criteria:<br><br> 1. Acute or chronic disease or illness that would increase operative risk or confound<br> the results of the study (e.g., dry eye disease, cataract, glaucoma,<br> immuno-compromised, rheumatoid arthritis, clinically significant atopic disease,<br> acne rosacea, autoimmune disease, endocrine disorders, lupus, systemic connective<br> tissue disease, diabetes, or severe atopic disease).<br><br> 2. Use of medications by any administration route that may increase risk to the subject<br> or may confound the outcome of the study, including those known to affect wound<br> healing (e.g., systemic corticosteroids, antimetabolites).<br><br> 3. Ocular conditions, other than hyperopia with or without astigmatism that may<br> predispose the subject to future complications including but not limited to:<br><br> 1. Evidence or history of retinal vascular disease<br><br> 2. Evidence or history of active or inactive corneal disease or infection (e.g.,<br> recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis)<br> in either eye.<br><br> 3. Evidence or history of glaucoma or glaucoma suspect (IOP > 24 mmHg) by exam<br> findings and/or family history.<br><br> 4. Previous intraocular or corneal surgery in an eye considered for eligibility that<br> might confound the outcome of the study or increase the risk to the subject.<br><br> 5. An increased risk for developing strabismus post-treatment or an ocular muscle<br> disorder (e.g., strabismus or nystagmus) affecting fixation.<br><br> 6. Known sensitivity to any study medications (e.g., used during LASIK procedure and<br> postoperative care).<br><br> 7. Have central corneal scars affecting visual acuity.<br><br> 8. Presence of keratoconus, keratoconus suspect, subclinical or forme fruste<br> keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular<br> astigmatism) or abnormal corneal topography<br><br> 9. Presence of visually significant or progressive cataract in an eye considered for<br> eligibility.<br><br> 10. Actively taking medications contraindicated with LASIK such as isotretinoin<br> (Accutane) or amiodarone hydrochloride (Cordarone).<br><br> 11. Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic<br> device.<br><br> 12. Pregnant, lactating, or subjects who plan to become pregnant during the course of<br> the study.<br><br> 13. Are participating in any other trial within 30 days of screening or during this<br> clinical trial.<br><br> 14. Eyes with mesopic pupil size > 7.0 mm.<br><br> 15. Have a Schirmer's pre-operative test without anesthesia < 4 mm after 5 minutes.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability;The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 0.50 Diopter of intended correction at the time of refractive stability;The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 1.00 Diopter of intended correction at the time of refractive stability