Myopic AstigmatismNCT07377474
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
A study testing TENEO 317 Model 2 (1.28 US) Excimer Laser in people with Myopic Astigmatism, run by Bausch & Lomb Incorporated.
Trial summary
This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery to treat myopia or myopic astigmatism. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Myopic Astigmatism
- What is being tested?
- TENEO 317 Model 2 (1.28 US) Excimer Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Sep 2027
- 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
- Are 22 years of age or older.
- Have read, understood, and signed an ICF.
- Have demonstrated stable refraction (i.e., a change of ≤ ± 0.5 D in sphere and cylinder) for a minimum of 12 months prior to surgery verified by consecutive refractions, medical records or prescription history.
- Have myopic refractive error with or without astigmatism; sphere 0.00 D up to -1.00 D, cylinder between 0.00 D and -3.00 D; with a manifest refraction spherical equivalent (MRSE) between -.0375 D and -2.50 D.
- Wears distance correction or has a need for distance correction.
- Have manifest, distance best spectacle corrected visual acuity (BSCVA) of 20/25 (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.
- Anticipated postoperative stromal thickness of at least 350 microns.
- 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 two 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.
- Agree to emmetropia correction for each treated eye
- 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
- Subjects 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.
- 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).
- Ocular conditions that may predispose the subject to future complications, including but not limited to:
- History or evidence 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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- 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.
- Subjects 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 (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis, etc.) 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.
- Presence of keratoconus, subclinical or forme fruste keratoconus, corneal dystrophy, unstable central keratometry readings with irregular mires, or other corneal irregularity (e.g., irregular astigmatism).
- 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 subject.
- Use chronic 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., corticosteroids, antimetabolites, etc.).
- Are taking medications contraindicated with 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, e.g., 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.
- Eyes with mesopic pupil size > 7.0 mm.
- Have a Schirmer's pre-operative test without anesthesia < 4 mm/5 minutes
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 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 With Sphere Between 0.00D and -1.00D
This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery to treat myopia or myopic astigmatism. One or both eyes of a subject may be treated so long as both eyes meet all inclusion/exclusion requirements.
- Conditions
- Myopic Astigmatism
- Being tested
- TENEO 317 Model 2 (1.28 US) Excimer Laser
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENEO 317 Model 2 (1.28 US) Excimer LaserDevice
Surgery to Treat Myopia or Myopic Astigmatism with Sphere between 0.00D and -1.00D
| Study group | Role | What they receive |
|---|---|---|
| TENEO 317 Model 2 (1.28 US) Excimer Laser | Experimental | Not described Receives: Device: TENEO 317 Model 2 (1.28 US) Excimer Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 0.50 D
Measured: Assessed for approximately 12 months
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 1.00 D
Measured: Assessed for approximately 12 months
The percentage of eyes that achieve a UDVA of 20/40 or better
Measured: Assessed for approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic AstigmatismStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosangela Sonner, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377474
- Sponsor's protocol ID
- BL-SU01-TENLMY-6301
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- 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 30 Jan 2026. 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 With Sphere Between 0.00D and -1.00D
- ClinicalTrials.gov ID
- NCT07377474
- Acronym / sponsor ID
- BL-SU01-TENLMY-6301
- Conditions
- Myopic Astigmatism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Jan 2026 (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.
This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery to treat myopia or myopic astigmatism. One or both eyes of a subject may be treated so long as both eyes meet all inclusion/exclusion requirements.
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 (1.28 US) Excimer Laser | Experimental | Device: TENEO 317 Model 2 (1.28 US) Excimer Laser |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Are 22 years of age or older.
- Have read, understood, and signed an ICF.
- Have demonstrated stable refraction (i.e., a change of ≤ ± 0.5 D in sphere and cylinder) for a minimum of 12 months prior to surgery verified by consecutive refractions, medical records or prescription history.
- Have myopic refractive error with or without astigmatism; sphere 0.00 D up to -1.00 D, cylinder between 0.00 D and -3.00 D; with a manifest refraction spherical equivalent (MRSE) between -.0375 D and -2.50 D.
- Wears distance correction or has a need for distance correction.
Key exclusion criteria (24 listed)
- Subjects 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.
- 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).
- Ocular conditions that may predispose the subject to future complications, including but not limited to:
- 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.
- Subjects 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.
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 (1.28 US) Excimer LaserSurgery to Treat Myopia or Myopic Astigmatism with Sphere between 0.00D and -1.00D | Device | TENEO 317 Model 2 (1.28 US) Excimer Laser |
Primary outcome
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 0.50 D
Time frame: Assessed for approximately 12 months
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 1.00 D
Time frame: Assessed for approximately 12 months
The percentage of eyes that achieve a UDVA of 20/40 or better
Time frame: Assessed for approximately 12 months
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 30 Jan 2026.
- 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.
Rosangela Sonner study director
Bausch & Lomb Incorporated
Questions about this trial
What is this clinical trial studying?
A study testing TENEO 317 Model 2 (1.28 US) Excimer Laser in people with Myopic Astigmatism, 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 14 inclusion and 24 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 30 Jan 2026. 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?
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 0.50 D (time frame: Assessed for approximately 12 months). The study lists 3 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 30 Jan 2026.