MyopiaNCT04111757
A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic Astigmatism
A study testing Technolas® TENEO 317 Model 2 in people with Myopia and Myopic Astigmatism, run by Bausch & Lomb Incorporated at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Myopia, Myopic Astigmatism
- What is being tested?
- Technolas® TENEO 317 Model 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 Jul 2019to 6 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Have the presence of systemic disease likely to affect wound healing, for example, autoimmune disease, systemic connective tissue disease, diabetes, or severe atopic disease.
- Are participating in any other ophthalmic clinical trial within 30 days of screening or during this clinical trial.
- Have an ocular muscle disorder including a strabismus or nystagmus, or other disorder affecting fixation.
- Have a history of or evidence of glaucoma or are a glaucoma suspect.
- Have eyes with mesopic pupil size >7.0 millimeters (mm).
- Have a Schirmer's pre-operative test without anesthesia <4 mm/5 minutes.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Bausch Site 102
Amherst, New York, 14228
Bausch Site 110
Blaine, Minnesota, 55434
Bausch Site 107
Bloomington, Minnesota, 55420
Bausch Site 105
Cedar Park, Texas, 78613
Bausch Site 104
Greensboro, North Carolina, 27401
Bausch Site 103
Mt. Pleasant, South Carolina, 29464
Bausch Site 101
Newport Beach, California, 92663
Bausch Site 108
Omaha, Nebraska, 68105
Bausch Site 106
Portsmouth, New Hampshire, 03801
Bausch Site 109
Sioux Falls, South Dakota, 57108
About this study
Official title: A Study to Investigate the Safety and Effectiveness of the Technolas® TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic Astigmatism
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.
Read the detailed description
Technolas TENEO 317 Model 2 excimer laser is a scanning excimer laser that operates at 193 nm ultraviolet wavelength to photoablate corneal tissue in order to achieve a refractive change. It is planned to enroll and treat up to 334 participant eyes, with an expectation that 300 study eyes will complete post-surgical follow-up for 6 months or until the point of achieved refractive stability. When a cohort of at least 300 eyes has achieved refractive stability at 6 months post-surgery, all other treated eyes that have not reached the 6-month examination may be discontinued at the Sponsor's request. Or, if 300 eyes achieve refractive stability at 9 months post-surgery, all other treated eyes that have not reached the 9-month examination may be discontinued
- Conditions
- Myopia, Myopic Astigmatism
- Being tested
- Technolas® TENEO 317 Model 2
- Keywords
- LASIK, Excimer Laser
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technolas® TENEO 317 Model 2Device
LASIK eye surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Technolas® TENEO 317 Model 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed at Month 3 to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start25 Jul 2019
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111757
- Sponsor's protocol ID
- 884
- Status last verified
- May 2022
- First submitted
- 30 Sep 2019
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety and Effectiveness of the Technolas® TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic Astigmatism
- ClinicalTrials.gov ID
- NCT04111757
- Acronym / sponsor ID
- 884
- Conditions
- Myopia, Myopic Astigmatism
- Keywords
- LASIK, Excimer Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Technolas TENEO 317 Model 2 excimer laser is a scanning excimer laser that operates at 193 nm ultraviolet wavelength to photoablate corneal tissue in order to achieve a refractive change. It is planned to enroll and treat up to 334 participant eyes, with an expectation that 300 study eyes will complete post-surgical follow-up for 6 months or until the point of achieved refractive stability. When a cohort of at least 300 eyes has achieved refractive stability at 6 months post-surgery, all other treated eyes that have not reached the 6-month examination may be discontinued at the Sponsor's request. Or, if 300 eyes achieve refractive stability at 9 months post-surgery, all other treated eyes that have not reached the 9-month examination may be discontinued
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Technolas TENEO 317 Model 2 | Experimental | Device: Technolas® TENEO 317 Model 2One 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technolas® TENEO 317 Model 2LASIK eye surgery | Device | Technolas TENEO 317 Model 2 |
Primary outcome
Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D
Time frame: Assessed at Month 3 to Month 9
Predictability is defined as the difference between the attempted and achieved manifest refraction spherical equivalent (MRSE) at the time of refractive stability.
Percentage of Eyes Targeted for Emmetropia That Achieve Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better
Time frame: Assessed at Month 3 to Month 9
Percentage of eyes targeted for emmetropia that achieve UDVA of 20/40 or better at the point at which refractive stability is reached.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anya Loncaric study director
Bausch & Lomb Incorporated
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technolas® TENEO 317 Model 2 in people with Myopia and Myopic Astigmatism, run by Bausch & Lomb Incorporated at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D (time frame: Assessed at Month 3 to Month 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024; AzTrials last refreshed its copy on 28 Oct 2026.