MyopiaNCT06618547
Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia With or Without Astigmatism by Transepithelial Photorefractive Keratectomy
A study testing TENEO 317 Model 2 excimer laser in people with Myopia, run by Bausch & Lomb Incorporated.
Trial summary
A Study to Investigate the Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia with or without Astigmatism by Transepithelial Photorefractive Keratectomy Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- TENEO 317 Model 2 excimer laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 22 years of age or older at the time of the pre-operative examination.
- Best distance corrected visual acuity (BCDVA) 20/25 or better in the study eye
- Difference between manifest refractive spherical equivalent (MRSE) and the cycloplegic refraction of ≤ 0.75 D in the study eye.
- Stable refraction (i.e., a change of ≤ 0.50 D in MRSE) for a minimum of 12 months before surgery, as verified by consecutive refractions, medical records, or prescription history.
- Agree to discontinue contact lenses for at least two weeks (for rigid or toric lenses) or three days (for soft contact lenses) before the first refraction to establish stability and through the day of surgery.
- A stable refraction (within ± 0.50 D) after discontinuation of contact lens(es), as determined by MRSE between two consecutive examinations at least one week apart.
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- Normal corneal topography per the investigator in the study eye.
- Anticipated postoperative stromal thickness of at least 350 microns.
- Ability to 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.
- Pre-operative myopic refractive error with sphere component from -0.25 D to -8.00 D in each operative eye, with or without cylinder from 0.00 D to -3.00 D, based on the manifest refraction with treated MRSE of -0.25 D to -9.50 D.
Who cannot join
- Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye, cataract, immuno-compromise, 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 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 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 (e.g., IOP > 21 mmHg).
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- Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the study's outcome or increase the subject's risk.
- 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 TransEpi PRK procedure and postoperative care).
- 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 TransEpi PRK, such as isotretinoin (Accutane®) or amiodarone hydrochloride (Cordarone®).
- Cardiac pacemaker, implanted defibrillator, or another implanted electronic device.
- Pregnant, lactating, or subjects who plan to become pregnant during the study.
- Participation in any other clinical trial within 30 days of screening or during this clinical trial.14. Subjects for whom the pre-operative assessment of the cornea/ eyes indicates that one or both eyes are not suitable candidates for treatment based upon the investigator's medical judgment.
- 15. Treated eye with mesopic pupil size > 7.0 mm.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study to Investigate the Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia With or Without Astigmatism by Transepithelial Photorefractive Keratectomy
A Study to Investigate the Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia with or without Astigmatism by Transepithelial Photorefractive Keratectomy
- Conditions
- Myopia
- Being tested
- TENEO 317 Model 2 excimer laser
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENEO 317 Model 2 excimer laserDevice
TENEO 317 Model 2 excimer laser by Transepithelial Photorefractive Keratectomy
| Study group | Role | What they receive |
|---|---|---|
| TENEO 317 Model 2 excimer laser | Experimental | Not described Receives: Device: TENEO 317 Model 2 excimer laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of BCDVA -
lines lost <5% of eyes with a loss of >2 lines of BCDVA at the stability visit
Measured: through study completion, an average of 1 year
Maintenance of BCDVA -
preservation 20/40 <1% of eyes with a BCDVA of 20/20 or better preoperatively that have a BCDVA worse than 20/40 at the stability visit
Measured: through study completion, an average of 1 year
Induced manifest refractive astigmatism
<5% of eyes with induced manifest refractive astigmatism greater >2 diopters at the stability visit
Measured: through study completion, an average of 1 year
Induced manifest refractive astigmatism
< 1% of eyes with serious adverse events by type of event observed through the final study visit.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618547
- Sponsor's protocol ID
- 907
- Status last verified
- Jun 2025
- First submitted
- 26 Sep 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia With or Without Astigmatism by Transepithelial Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT06618547
- Acronym / sponsor ID
- 907
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Investigate the Effectiveness and Safety of the TENEO 317 Model 2 Excimer Laser to Treat Myopia with or without Astigmatism by Transepithelial Photorefractive Keratectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENEO 317 Model 2 excimer laser | Experimental | Device: TENEO 317 Model 2 excimer laser |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 22 years of age or older at the time of the pre-operative examination.
- Best distance corrected visual acuity (BCDVA) 20/25 or better in the study eye
- Difference between manifest refractive spherical equivalent (MRSE) and the cycloplegic refraction of ≤ 0.75 D in the study eye.
- Stable refraction (i.e., a change of ≤ 0.50 D in MRSE) for a minimum of 12 months before surgery, as verified by consecutive refractions, medical records, or prescription history.
- Agree to discontinue contact lenses for at least two weeks (for rigid or toric lenses) or three days (for soft contact lenses) before the first refraction to establish stability and through the day of surgery.
Key exclusion criteria (17 listed)
- Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye, cataract, immuno-compromise, 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 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 that may predispose the subject to future complications, including but not limited to:
- Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the study's outcome or increase the subject's risk.
- An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation.
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 |
|---|---|---|
| TENEO 317 Model 2 excimer laserTENEO 317 Model 2 excimer laser by Transepithelial Photorefractive Keratectomy | Device | TENEO 317 Model 2 excimer laser |
Primary outcome
Maintenance of BCDVA -
Time frame: through study completion, an average of 1 year
lines lost <5% of eyes with a loss of >2 lines of BCDVA at the stability visit
Maintenance of BCDVA -
Time frame: through study completion, an average of 1 year
preservation 20/40 <1% of eyes with a BCDVA of 20/20 or better preoperatively that have a BCDVA worse than 20/40 at the stability visit
Induced manifest refractive astigmatism
Time frame: through study completion, an average of 1 year
<5% of eyes with induced manifest refractive astigmatism greater >2 diopters at the stability visit
Induced manifest refractive astigmatism
Time frame: through study completion, an average of 1 year
< 1% of eyes with serious adverse events by type of event observed through the final study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TENEO 317 Model 2 excimer laser in people with Myopia, run by Bausch & Lomb Incorporated.
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 17 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: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Carson (4035025307, Dennis.Carson@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of BCDVA - (time frame: through study completion, an average of 1 year). The study lists 4 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 15 Jun 2025.