RecruitingNot Applicable

Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2

Czechia81 participantsStarted 2025-06-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better

Timeframe: Assessed for approximately 90 days

Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better

Timeframe: Assessed for approximately 90 days

Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 0.50 D

Timeframe: Assessed for approximately 90 days

Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 1.00 D

Timeframe: Assessed for approximately 90 days

Trial details

NCT IDNCT06997003

SponsorBausch & Lomb GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Daniel Sagan

+49 1726927757 daniel.sagan@bausch.com

View on ClinicalTrials.gov More Hyperopia and Myopia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Percentage of eyes that achieve a Uncorrected Distance Visual Acuity of 20/40 or better

Timeframe: Assessed for approximately 90 days

Percentage of participants with binocular Uncorrected Distance Visual Acuity of 20/40 or better

Timeframe: Assessed for approximately 90 days

Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 0.50 D

Timeframe: Assessed for approximately 90 days

Percentage of eyes that achieve predictability (attempted versus achieved) of Manifest Refraction Spherical Equivalent (MRSE) within ± 1.00 D

Timeframe: Assessed for approximately 90 days