Actively Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Led by Bausch & Lomb GmbH · Updated on 2025-06-22
81
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for bilateral laser refractive surgery targeting near-normal vision (emmetropia) with an attempted correction between -0.50 D and +0.50 D
- At least 18 years old
- Have read, understood, and signed informed consent
- Have stable vision with less than or equal to 0.50 D change in prescription in both eyes
- Less than 0.75 D difference between cycloplegic and manifest refractions before surgery
- For hyperopia group: sphere between 0.00 D and 4.00 D, cylinder between 0.00 D and 3.00 D, spherical equivalent between 0.50 D and 5.50 D in both eyes
- For myopia groups: sphere between -8.00 D and 0.00 D, cylinder between 0.00 D and -4.00 D, spherical equivalent between -10.00 D and -1.00 D in both eyes
- Corrected distance visual acuity of 20/25 or better in both eyes
- Normal corneal shape as determined by the investigator
- Discontinued contact lenses use for at least 2 weeks for hard lenses or 3 days for soft lenses before pre-operative exam and surgery
- Stable refraction within �b1 0.50 D on two exams at least 1 week apart for contact lens wearers
- Able to lie flat without difficulty
- Willing and able to attend all post-surgery follow-up visits
You will not qualify if you...
- Corneal thickness and surgery parameters that leave less than 250 microns of residual corneal tissue in any eye
- Tear Break-Up Time less than 8 seconds in any eye
- Pupil size in low light larger than the planned treatment zone in any eye
- History or signs of corneal disease or infection in either eye
- Central corneal scars affecting vision or unstable corneal measurements
- Irregular astigmatism in any eye
- Keratoconus or suspected keratoconus, or corneal dystrophy in any eye
- Previous eye surgery that could affect study results or increase risk
- Eye muscle disorders affecting eye movement or fixation
- Retinal vascular disease in any eye
- History or signs of glaucoma or glaucoma suspect
- Acute or chronic illness increasing surgery risk or affecting healing (e.g., immune disorders, connective tissue disease, significant allergies, diabetes)
- Use of chronic systemic medications that increase risk or affect study outcomes (such as steroids, antimetabolites)
- Use of medications contraindicated with LASIK (e.g., isotretinoin, amiodarone hydrochloride)
- Known allergy to medications used in LASIK
- Females of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective birth control during the study
- Participation in another drug or device trial within 30 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Site 01
Zlín, Czech Republic, Czechia, 76001
Actively Recruiting
Research Team
D
Daniel Sagan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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