New laser aims to sharpen vision for the farsighted
NCT ID NCT05264623
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the safety and effectiveness of the TENEO 317 excimer laser used in LASIK surgery to treat farsightedness (hyperopia) with or without astigmatism. About 140 adults aged 22 and older will receive the laser treatment in one or both eyes and be followed for 12 months. The main goals are to see if vision improves to 20/40 or better without glasses and if the prescription correction is accurate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TENEO 317 Model 2 excimer laser (device)
- What this could lead to
- If successful, this laser could offer a safe and effective option for LASIK surgery to correct farsightedness and astigmatism.
- What could go wrong
- This is a single-arm, non-randomized study with no comparison group, so results may not apply broadly. Risks include typical LASIK complications like dry eyes or vision issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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140 people
The number who actually took part.
- Started
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Nov 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects 22 years of age or older at the time of the pre-operative examination. 2. Manifest, distance corrected visual acuity (CDVA) 20/25 (logMAR 0.10) or better in an operative eye 3. 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) 4. Difficulty maintaining uncorrected distance visual acuity (UDVA) of 20/40 or better, as evidenced by need for constant contact lens or spectacle wear. 5. 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. 6. 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. 7. 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. 8. 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. 9. Agree to emmetropia correction for each treated eye. 10. Anticipated postoperative stromal bed thickness of at least 250 microns. 11. Can lie flat without difficulty. 12. Willing and able to read, understand, and sign a written informed consent form (ICF). 13. Willing and able to comply with the schedule for all post-surgery follow-up visits. Exclusion Criteria: 1. 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). 2. 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). 3. Ocular conditions, other than hyperopia with or without astigmatism that may predispose the subject to future complications including but not limited to: 1. Evidence or history of retinal vascular disease 2. 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. 3. Evidence or history of glaucoma or glaucoma suspect (IOP \> 24mmHg) by exam findings and/or family history 4. 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. 5. An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation. 6. Known sensitivity to any study medications (e.g., used during LASIK procedure and postoperative care). 7. Have central corneal scars affecting visual acuity. 8. Have mixed astigmatism. 9. Presence of keratoconus, keratoconus suspect, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism) or abnormal corneal topography 10. Presence of visually significant or progressive cataract in an eye considered for eligibility. 11. Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone). 12. Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device. 13. Pregnant, lactating, or subjects who plan to become pregnant during the course of the study. 14. Are participating in any other trial within 30 days of screening or during this clinical trial. 15. Eyes with mesopic pupil size \> 7.0 mm. 16. Have a Schirmer's pre-operative test without anesthesia \< 4 mm after 5 minutes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Site 101
Bloomington, Minnesota, 55420, United States
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Site 102
Amherst, New York, 14228, United States
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Site 103
Omaha, Nebraska, 68118, United States
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Site 104
Saint Louis Park, Minnesota, 55416, United States
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Site 106
Cedar Park, Texas, 78613, United States
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Site 108
Sioux Falls, South Dakota, 57108, United States
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Site 111
Fort Myers, Florida, 33912, United States
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Site 112
Pittsburgh, Pennsylvania, 15213, United States
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Site 113
Newport Beach, California, 92660, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Wearable tech takes on the myopia epidemic: a School-Based trial
- Ear seeds: a Needle-Free hope against childhood nearsightedness?
- Can a donated corneal lens correct hard-to-tract high hyperopia and astigmatism?
- Laser touch-up may sharpen blurry vision after cataract surgery
- Eye study aims to map corneal thickness in common vision problems
- New contact lens study tests better comfort for astigmatism sufferers