Laser breakthrough: new procedure aims to zap away nearsightedness
NCT ID NCT01638390
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 trial tested the VisuMax femtosecond laser to correct nearsightedness (myopia) in 357 adults aged 22 and older. The procedure removes a small lens-shaped piece of the cornea to reshape the eye and improve vision. Researchers measured how well the treatment reduced the need for glasses, with targets for accuracy and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VisuMax femtosecond laser (device)
- What this could lead to
- If successful, this laser procedure could offer a safe and effective way to reduce or eliminate nearsightedness, potentially reducing the need for glasses or contact lenses.
- What could go wrong
- This is an early Phase 1 trial, so results are preliminary. Risks include under- or over-correction, infection, or vision loss, though safety targets were set low.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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357 people
The number who actually took part.
- Start date
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Jul 2012
- Finished
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Apr 2016
- 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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Accepted
You do not need to have the condition being studied to take part.
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: * Male and female subjects age 22 years of age and older; * Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated; * A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated; * A difference between cycloplegic and manifest refractions of \< 0.75 D spherical equivalent in the eye to be treated; * UCVA worse than 20/40 in the eye to be treated; * BSCVA at least 20/20 in the eye to be treated; * Discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery; * All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated; * Central corneal thickness of at least 500 microns in the eye to be treated; * Willing and able to return for scheduled follow-up examinations; * Able to provide written informed consent and follow study instructions in English. Exclusion Criteria: * Mesopic pupil diameter \> 8.0 mm; * Cylinder \> -0.50 D; * Treatment depth is less than 250 microns from the corneal endothelium; * Eye to be treated is targeted for monovision; * Fellow eye has BSCVA worse than 20/40; * Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye; * History of or current anterior segment pathology, including cataracts in the eye to be treated; * Clinically significant dry eye syndrome unresolved by treatment in either eye; * Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated; * Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye; * Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye; * History of ocular herpes zoster or herpes simplex keratitis; * Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction; * Difficulty following directions or unable to fixate; * Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes; * History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP \> 21 mmHg in either eye; * History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome; * Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing; * History of known sensitivity to planned study medications; * Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation; * Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
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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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Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
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Davis Duehr Dean
Madison, Wisconsin, 53717, United States
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Discover Vision Centers
Leawood, Kansas, 66211, United States
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Dishler Laser Institute
Greenwood Village, Colorado, 80111, United States
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Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
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