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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hyperopia

Intervention / Treatment
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* Device: TENEO 317 Model 2 excimer laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 22 years of age or older at the time of the pre-operative examination. Manifest, distance best spectacle corrected visual acuity (BSCVA) 20/25 (logMAR 0.10) or better in an operative eye 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). Difficulty maintaining uncorrected distance visual acuity (UDVA) of 20/40 or better, as evidenced by need for constant contact lens or spectacle wear. Difference between manifest refractive spherical equivalent (MRSE) and the cycloplegic refraction of < 0.75 D 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. 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. 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. Agree to emmetropia correction for each treated eye. Anticipated postoperative stromal bed thickness of at least 250 microns. Can lie flat without difficulty. Willing and able to read, understand, and sign a written informed consent form (ICF). Willing and able to comply with the schedule for all post-surgery follow-up visits. Exclusion Criteria: 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). 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). Ocular conditions, other than hyperopia with or without astigmatism that may predispose the subject to future complications including but not limited to: Evidence or history of retinal vascular disease History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye. History of or evidence of glaucoma or glaucoma suspect (IOP > 24 mmHg). 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. An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation. Known sensitivity to any study medications (e.g., used during LASIK procedure and postoperative care). Have central corneal scars affecting visual acuity. Presence of keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism). Presence of visually significant or progressive cataract in an eye considered for eligibility. Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone). Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device. Pregnant, lactating, or subjects who plan to become pregnant during the course of the study. Are participating in any other trial within 30 days of screening or during this clinical trial. Eyes with mesopic pupil size > 7.0 mm. Have a Schirmer's pre-operative test without anesthesia < 4 mm/5 minutes.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENEO 317 Model 2 excimer laser<br> | Device: TENEO 317 Model 2 excimer laser<br>* TENEO 317 Model 2 excimer laser use for refractive surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |