HyperopiaNCT05264623
Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism
A study testing TENEO 317 Model 2 excimer laser in people with Hyperopia, run by Bausch & Lomb Incorporated at 9 sites in United States.
Trial summary
This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hyperopia
- 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
- 9 sitesUnited States
- Study dates
- 15 Nov 2022to 24 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects 22 years of age or older at the time of the pre-operative examination.
- Manifest, distance corrected visual acuity (CDVA) 20/25 (logMAR 0.10) or better in an operative eye
- Pre-operative refractive error of hyperopia with spherical component of 0.00 D to +4.00 D with or without cylinder up to +2.00 D, with MRSE of ≥ 0.375 D and ≤ +5.00 D based on the manifest refraction in thestudy eye(s). This would exclude eyes with cylinder-only corrections < +0.75D and sphere-only corrections < +0.375D)
- Difficulty maintaining uncorrected distance visual acuity (UDVA) of 20/40 or better, as evidenced by need for constant contact lens or spectacle wear.
- Difference between manifest refractive and cycloplegic spherical equivalent ≤ 0.75 D, difference between manifest and cycloplegic cylinder ≤ ± 0.50 D and difference between manifest and cycloplegic cylinder axis ≤ ± 15 degrees.
- Stable refraction (i.e., a change of ≤ ± 0.50 D in MRSE) for a minimum of 12 months prior to surgery, as verified by consecutive refractions, medical records, or prescription history.
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- Agree to discontinue use of contact lenses for at least 2 weeks (for rigid or toric lenses) or 3 days (for soft contact lenses) prior to the first refraction used to establish stability and through the day of surgery.
- All contact lens wearers must demonstrate a stable refraction in an eye to be treated, as follows: two consecutive examinations at least 1 week apart within ± 0.50 D manifest refractive spherical equivalent and within ± 15 degrees cylinder axis.
- Agree to emmetropia correction for each treated eye.
- Anticipated postoperative stromal bed thickness of at least 250 microns.
- Can 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.
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 disease, cataract, glaucoma, immuno-compromised, 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 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., systemic corticosteroids, antimetabolites).
- Ocular conditions, other than hyperopia with or without astigmatism that may predispose the subject to future complications including but not limited to:
- Evidence or history of retinal vascular disease
- Evidence or history of active or inactive corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.
- Evidence or history of glaucoma or glaucoma suspect (IOP > 24mmHg) by exam findings and/or family history
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- 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.
- 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 LASIK procedure and postoperative care).
- Have central corneal scars affecting visual acuity.
- Have mixed astigmatism.
- Presence of keratoconus, keratoconus suspect, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism) or abnormal corneal topography
- Presence of visually significant or progressive cataract in an eye considered for eligibility.
- Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).
- Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.
- Pregnant, lactating, or subjects who plan to become pregnant during the course of the study.
- Are participating in any other trial within 30 days of screening or during this clinical trial.
- Eyes with mesopic pupil size > 7.0 mm.
- Have a Schirmer's pre-operative test without anesthesia < 4 mm after 5 minutes
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Site 102
Amherst, New York, 14228
Site 101
Bloomington, Minnesota, 55420
Site 106
Cedar Park, Texas, 78613
Site 111
Fort Myers, Florida, 33912
Site 113
Newport Beach, California, 92660
Site 103
Omaha, Nebraska, 68118
Site 112
Pittsburgh, Pennsylvania, 15213
Site 104
Saint Louis Park, Minnesota, 55416
Site 108
Sioux Falls, South Dakota, 57108
About this study
Official title: A Study to Investigate the Safety and Effectiveness of the TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism
This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.
- Conditions
- Hyperopia
- Being tested
- TENEO 317 Model 2 excimer laser
- Medical subject headings
- Hyperopia
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 use for refractive surgery
| 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.
The percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability
Measured: Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 0.50 Diopter of intended correction at the time of refractive stability
Measured: Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 1.00 Diopter of intended correction at the time of refractive stability
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start15 Nov 2022
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperopiaStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosangela Nolasco, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264623
- Sponsor's protocol ID
- 906
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 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 TENEO 317 Model 2 (1.28 US) Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Hyperopia With or Without Astigmatism
- ClinicalTrials.gov ID
- NCT05264623
- Acronym / sponsor ID
- 906
- Conditions
- Hyperopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 3 Mar 2022 (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 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.
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 (13 listed)
- Subjects 22 years of age or older at the time of the pre-operative examination.
- Manifest, distance corrected visual acuity (CDVA) 20/25 (logMAR 0.10) or better in an operative eye
- Pre-operative refractive error of hyperopia with spherical component of 0.00 D to +4.00 D with or without cylinder up to +2.00 D, with MRSE of ≥ 0.375 D and ≤ +5.00 D based on the manifest refraction in thestudy eye(s). This would exclude eyes with cylinder-only corrections < +0.75D and sphere-only corrections < +0.375D)
- Difficulty maintaining uncorrected distance visual acuity (UDVA) of 20/40 or better, as evidenced by need for constant contact lens or spectacle wear.
- Difference between manifest refractive and cycloplegic spherical equivalent ≤ 0.75 D, difference between manifest and cycloplegic cylinder ≤ ± 0.50 D and difference between manifest and cycloplegic cylinder axis ≤ ± 15 degrees.
Key exclusion criteria (19 listed)
- Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye disease, cataract, glaucoma, immuno-compromised, 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 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., systemic corticosteroids, antimetabolites).
- Ocular conditions, other than hyperopia with or without astigmatism 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 outcome of the study or increase the risk to the subject.
- 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 use for refractive surgery | Device | TENEO 317 Model 2 excimer laser |
Primary outcome
The percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability
Time frame: Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 0.50 Diopter of intended correction at the time of refractive stability
Time frame: Up to 12 months
The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 1.00 Diopter of intended correction at the time of refractive stability
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruiting
The Emmetropization Via Accommodation (EVA) - II Study
Hyperopia, Farsightedness
Recruiting
Eye Imaging for the Study of Childhood Myopia
Hyperopia and Myopia
Recruiting
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
Myopia, Refractive Errors
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. This study is not recruiting at the moment.
Rosangela Nolasco study director
Bausch & Lomb Incorporated
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENEO 317 Model 2 excimer laser in people with Hyperopia, run by Bausch & Lomb Incorporated at 9 sites in United States.
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 19 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability (time frame: Up to 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 8 Oct 2026.