Clinical trial NCT05264623: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 140
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability
timeFrame: Up to 12 months
measure: The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 0.50 Diopter of intended correction at the time of refractive stability
timeFrame: Up to 12 months
measure: The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 1.00 Diopter of intended correction at the time of refractive stability
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Site 113
state: California
city: Fort Myers
country: United States
facility: Site 111
state: Florida
city: Bloomington
country: United States
facility: Bausch Site 101
state: Minnesota
city: Saint Louis Park
country: United States
facility: Bausch Site 104
state: Minnesota
city: Omaha
country: United States
facility: Bausch Site 103
state: Nebraska
city: Portsmouth
country: United States
facility: Bausch Site 105
state: New Hampshire
city: Amherst
country: United States
facility: Bausch Site 102
state: New York
city: Greensboro
country: United States
facility: Bausch Site 107
state: North Carolina
city: Pittsburgh
country: United States
facility: Site 112
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Bausch Site 109
state: South Carolina
city: Sioux Falls
country: United States
facility: Bausch Site 108
state: South Dakota
city: Cedar Park
country: United States
facility: Bausch Site 106
state: Texas
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Rosangela Nolasco
role: STUDY_DIRECTOR
References: