Hyperopia and MyopiaNCT06997003
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
A study testing Anterior treatment mode and Total treatment mode in people with Hyperopia and Myopia, run by Bausch & Lomb GmbH at 1 site in Czechia.
Trial summary
Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperopia and Myopia
- What is being tested?
- Anterior treatment mode and Total treatment mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Jun 2025to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects already scheduled for bilateral refractive laser surgery targeting emmetropia (attempted MRSE is between and including -0.50 D and +0.50 D).
- Minimum 18 years of age.
- Have read, understood, and signed an informed consent form (ICF).
- Have a stable refraction (i.e., a change of ≤ 0.50 D in sphere and cylinder) for both eyes as judged by the investigator.
- Have less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at preoperative visit for both eyes.
- Study group 1 only: Have hyperopic refractive error with or without astigmatism; sphere between 0.00 D and 4.00 D, cylinder between 0.00 D and 3.00 D for both eyes; with a spherical equivalent (SE) between 0.50 D and 5.50 D for both eyes.
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- Study groups 2 and 3 only: Have myopic refractive error with or without astigmatism; sphere between -8.00 D and 0.00 D, cylinder between 0.00 D and -4.00 D for both eyes; with a spherical equivalent (SE) between -10.00 D and -1.00 D for both eyes.
- Have CDVA of 20/25 (logMAR 0.1) or better in both eyes
- Have normal corneal topography as determined by the Investigator for both eyes.
- Have discontinued use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the pre-operative examination, and through the day of surgery.
- All contact lens wearers must demonstrate a stable refraction (within ± 0.50 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in both eyes and the axis of cylinder should not differ by more than 15 degrees from the baseline cycloplegic refraction for both eyes.
- 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 less than 250 microns residual stroma thickness in any eye.
- Tear Break-Up time (TBUT) <8 s in any eye.
- Mesopic pupil size larger than the optical zone of the planned treatment for any eye.
- History or evidence of active or inactive of corneal disease or infection in either eye (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal dystrophy, etc.).
- Central corneal scars affecting visual acuity or unstable keratometry with irregular mires in any eye.
- Irregular astigmatism in any eye.
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- Keratoconus or suspicion of keratoconus (sub-clinical, forme fruste), corneal dystrophy in any eye.
- Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject.
- Ocular muscle disorder including a strabismus or nystagmus, or other disorder affecting fixation in any eye.
- Evidence of retinal vascular disease in any eye.
- History or evidence glaucoma or glaucoma suspect in any eye.
- Acute or chronic disease or illness that would increase the operative risk, likely affect the wound healing or confound the outcomes of the study (e.g. immuno-compromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.).
- Use chronic systemic medications that may confound the outcome of the study or increase the risk to the subject, including, but not limited to steroids, antimetabolites, etc.;
- Take medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).
- Known sensitivity to medications used for standard LASIK treatment.
- Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: Pregnant, lactating or unwilling to use effective birth control over the course of the study.
- Concurrent or previous (within 30 days) participation in another drug or device investigation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of a New Customized Corneal Treatment for Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended.
- Conditions
- Hyperopia and Myopia
- Being tested
- Anterior treatment mode, Total treatment mode
- Medical subject headings
- Hyperopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior treatment modeDevice
Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Anterior treatment modeDevice
Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
Total treatment modeDevice
Laser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment
| Study group | Role | What they receive |
|---|---|---|
| Hyperopic eyes and anterior treatment mode | Experimental | Not described Receives: Device: Anterior treatment mode |
| Myopic eyes and anterior treatment mode | Experimental | Not described Receives: Device: Anterior treatment mode |
| Myopic eyes and total treatment mode | Experimental | Not described Receives: Device: Total treatment mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better
Measured: Assessed for approximately 90 days
Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better
Measured: Assessed for approximately 90 days
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 0.50 D
Measured: Assessed for approximately 90 days
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 1.00 D
Measured: Assessed for approximately 90 days
Secondary outcomes (4)
Preservation of Corrected Distance Visual Acuity (CDVA)
Percentage of eyes with CDVA worse than 20/40 at postoperative visit 3 if 20/20 or better preoperatively
Measured: Assessed for approximately 90 days
Preservation of Corrected Distance Visual Acuity (CDVA)
Percentage of eyes with CDVA loss > 2 lines (> 10 letters ETDRS scale) at visit 3
Measured: Assessed for approximately 90 days
Induced Manifest Refraction Astigmatism
Percentage of eyes that have a magnitude of postoperative manifest refractive astigmatism that increases from baseline cylinder by > 2.00 D at postoperative visit 3
Measured: Assessed for approximately 90 days
Incidence of Adverse Events
Percentage of eyes with treatment emergent adverse events occurred per event type
Measured: Assessed from 0-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start16 Jun 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperopia and 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natasa Orlic-Pleyer, Study director, Bausch & Lomb GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997003
- Sponsor's protocol ID
- BL-LC04-TENOCT-6401
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Customized Corneal Treatment for Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
- ClinicalTrials.gov ID
- NCT06997003
- Acronym / sponsor ID
- BL-LC04-TENOCT-6401
- Conditions
- Hyperopia and Myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Bausch & Lomb GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 May 2025 (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.
Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperopic eyes and anterior treatment mode | Experimental | Device: Anterior treatment mode |
| Myopic eyes and anterior treatment mode | Experimental | Device: Anterior treatment mode |
| Myopic eyes and total treatment mode | Experimental | Device: Total treatment mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects already scheduled for bilateral refractive laser surgery targeting emmetropia (attempted MRSE is between and including -0.50 D and +0.50 D).
- Minimum 18 years of age.
- Have read, understood, and signed an informed consent form (ICF).
- Have a stable refraction (i.e., a change of ≤ 0.50 D in sphere and cylinder) for both eyes as judged by the investigator.
- Have less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at preoperative visit for both eyes.
Key exclusion criteria (17 listed)
- Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns residual stroma thickness in any eye.
- Tear Break-Up time (TBUT) <8 s in any eye.
- Mesopic pupil size larger than the optical zone of the planned treatment for any eye.
- History or evidence of active or inactive of corneal disease or infection in either eye (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal dystrophy, etc.).
- Central corneal scars affecting visual acuity or unstable keratometry with irregular mires in any 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 |
|---|---|---|
| Anterior treatment modeLaser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment | Device | Hyperopic eyes and anterior treatment mode |
| Anterior treatment modeLaser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment | Device | Myopic eyes and anterior treatment mode |
| Total treatment modeLaser-in-situ-Keratomileusis (LASIK) surgery using OCTAVIUS treatment | Device | Myopic eyes and total treatment mode |
Primary outcome
Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better
Time frame: Assessed for approximately 90 days
Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better
Time frame: Assessed for approximately 90 days
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 0.50 D
Time frame: Assessed for approximately 90 days
Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 1.00 D
Time frame: Assessed for approximately 90 days
4 secondary outcomes
Preservation of Corrected Distance Visual Acuity (CDVA)
Time frame: Assessed for approximately 90 days
Preservation of Corrected Distance Visual Acuity (CDVA)
Time frame: Assessed for approximately 90 days
Induced Manifest Refraction Astigmatism
Time frame: Assessed for approximately 90 days
Incidence of Adverse Events
Time frame: Assessed from 0-90 days
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 22 Jun 2025.
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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.
Natasa Orlic-Pleyer study director
Bausch & Lomb GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior treatment mode and Total treatment mode in people with Hyperopia and Myopia, run by Bausch & Lomb GmbH at 1 site in Czechia.
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 13 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
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 Daniel Sagan (+49 1726927757, daniel.sagan@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better (time frame: Assessed for approximately 90 days). 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 22 Jun 2025.