A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic Astigmatism

NCT04111757 | Completed Results FDA Device

• 1 other identifier: 884
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective of this study is to collect safety and effectiveness data for the Technolas Teneo 317 Model 2 excimer laser for LASIK correction in participants with myopia and myopic astigmatism.

Conditions

Myopia; Myopic Astigmatism

Keywords

LASIK; Excimer Laser

Outcome Measures

Primary Outcomes (2)

• Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D

  Predictability is defined as the difference between the attempted and achieved manifest refraction spherical equivalent (MRSE) at the time of refractive stability.

  Assessed at Month 3 to Month 9

• Percentage of Eyes Targeted for Emmetropia That Achieve Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better

  Percentage of eyes targeted for emmetropia that achieve UDVA of 20/40 or better at the point at which refractive stability is reached.

  Assessed at Month 3 to Month 9

Study Arms (1)

Technolas TENEO 317 Model 2

EXPERIMENTAL

One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0.

Device: Technolas® TENEO 317 Model 2

Interventions

Technolas® TENEO 317 Model 2 DEVICE

LASIK eye surgery

Technolas TENEO 317 Model 2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 22 years of age or older.
• Have read, understood, and signed an informed consent form (ICF).
• Have demonstrated stable refraction (for example, a change of ≤0.5 D in sphere and cylinder) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
• Have myopic refractive error with or without astigmatism; sphere between -1.0 D and -10.00 D, cylinder between 0.0 D and -3.0 D; with a manifest refraction spherical equivalent (MRSE) between -1.0 D and -11.50 D.
• Have uncorrected distance visual acuity (UDVA) of 20/40 or worse.
• Have manifest distance best spectacle corrected visual acuity (BSCVA) of 20/25 (logarithm of the minimum angle of resolution \[logMAR\] 0.1) or better in an operative eye.
• Have equal to or less than 0.50 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at Visit 1 (pre-operative).
• Have normal corneal topography as determined by the Investigator.
• Have discontinued use of contact lenses for at least 2 weeks (for hard or toric lenses) or 3 days (for soft contact lenses) prior to the pre-operative examination, and through the day of surgery.
• All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on 2 consecutive examinations at least 1 week apart, in an eye to be treated and the axis of cylinder should not differ by more than 15 degrees from the baseline cycloplegic refraction.
• Have the ability to lie flat without difficulty.
• Are willing and able to comply with the schedule for all post-surgery follow-up visits.

You may not qualify if:

• Participants for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in treatment depth less than 250 microns from corneal endothelium.
• Eyes for which the baseline manifest subjective refraction exhibits a difference greater than 0.50 D in sphere power, or a difference greater than 0.50 D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than 0.50 D, the difference in cylinder axis will not be taken into consideration.
• Participants for whom the pre-operative assessment of the cornea indicates that one or both eyes are not suitable candidates for treatment based upon the Investigator's medical judgment.
• Have evidence of retinal vascular disease.
• Have a history of or have active corneal disease or infection (for example, recurrent corneal erosion syndrome, herpes simplex, or herpes zoster keratitis) in either eye.
• Have a known sensitivity to any study medication.
• Have central corneal scars affecting visual acuity or unstable keratometry with irregular mires in an eye considered for eligibility.
• Have keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (for example, irregular astigmatism).
• Have visually significant or progressive cataract in an eye considered for eligibility.
• Had 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 participant.
• Use chronic medications by any administration route that may increase risk to the participant or may confound the outcome of the study, including those known to affect wound healing (for example, corticosteroids, antimetabolites).
• Are known to have acute or chronic disease or illness (for example, dry eye, cataract, glaucoma, immuno-compromised, rheumatoid arthritis, clinically significant atopic disease, acne rosacea) that would increase operative risk or may confound the results of the study.
• Are taking medications contraindicated for LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).
• Are known to be pregnant, lactating, or who plan to become pregnant during the course of the study.
• Have known sensitivity to medications used for standard LASIK.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (10)

Bausch Site 101

Newport Beach, California, 92663, United States

Location

Bausch Site 110

Blaine, Minnesota, 55434, United States

Location

Bausch Site 107

Bloomington, Minnesota, 55420, United States

Location

Bausch Site 108

Omaha, Nebraska, 68105, United States

Location

Bausch Site 106

Portsmouth, New Hampshire, 03801, United States

Location

Bausch Site 102

Amherst, New York, 14228, United States

Location

Bausch Site 104

Greensboro, North Carolina, 27401, United States

Location

Bausch Site 103

Mt. Pleasant, South Carolina, 29464, United States

Location

Bausch Site 109

Sioux Falls, South Dakota, 57108, United States

Location

Bausch Site 105

Cedar Park, Texas, 78613, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Johnson Varughese
• Organization: Bausch & Lomb

johnson.varughese@bausch.com

9089271162

Study Officials

• Anya Loncaric

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 1, 2019
• Study Start: July 25, 2019
• Primary Completion: August 6, 2021
• Study Completion: August 6, 2021
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2022-05

Locations

US (10)