Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New laser system aims to sharpen vision for nearsighted patients

NCT ID NCT04200898

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new laser system called Cheetah to correct nearsightedness (myopia) with or without astigmatism. About 286 adults with mild to moderate nearsightedness received the treatment. The main goal was to see how many patients achieved clear vision without glasses one month after the procedure.

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

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

286 people

The number who actually took part.

Started

Dec 2019

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Note: All criteria apply to each Cheetah treated eye * Age ≥18 years old at the time of consenting. * Subjects with refractive error within the following ranges: * Phase I: Partially sighted eyes (as defined below) * Phase II: Refractive error range in the Cheetah-treated eye/s between -2.00 D to -6.00 D and astigmatism up to -1.00 D based on manifest refraction at optical infinity. If cyclotorsion correction after docking is available, astigmatism greater than -1. 00 D can be included, provided that spherical equivalent (SE) is up to -6.00 D. * Phase III: Myopic refractive error in the study eye up to -12.00 D spherical equivalent (SE) and astigmatism up to - 6.00 D based on manifest refraction at optical infinity. * Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus maximum lenticule thickness to be extracted. * Uncorrected visual acuity of 20/40 or worse in Phase II and III subjects. * Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better for phase II and III subjects. For phase I subjects, BSCVA and pin-hole acuity of the iLEX treated eye is worse than 20/50, with at least a 2-line difference between the iLEX treated eye and the fellow eye. Note: Potential phase I subjects to be evaluated on a case-by-case basis for interocular difference in visual acuity and enrollment to be confirmed through Medical Monitor and PI consensus. * BSCVA ≥2 lines better than distance Uncorrected Visual Acuity (UCVA). Not applicable for phase I subjects. * Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere. Not applicable for phase I subjects. * A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤1.00 D in MRSE. Additionally, the astigmatic axis must also be within 15 degrees for eyes with \>0.50 D of preoperative and historical manifest cylinder. * Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following: * Rigid contact lenses (toric or spherical) must be removed for at least 4 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability. * Two consecutive manifest refractions and keratometry readings must be conducted at least 7 days apart. * Refractive stability is defined as a change of not more than 0.50 D in manifest refractive sphere and cylinder as well as keratometry meridian (either axis) between measurements. If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted prior to surgery, as specified above for rigid and soft contact lens wearers. * Willing and capable of complying with follow-up examinations for the duration of the study. * Signed informed consent or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment. Exclusion Criteria: Note: All criteria apply to each eye * Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment. NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility. History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders), lupus, and rheumatoid arthritis. * Subjects with history of Diabetes Mellitus of 12 years or more and HbA1c measurement greater than 7% within a month prior to treatment. * Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device. * History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, history or evidence of corneal ulcer (including but not limited to presence of visible corneal scar, abnormal topography is NOT necessary), clinically significant dry eye syndrome, neovascularization \> 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography. Note: For phase I subjects (partially sighted eyes), history of intraocular surgery (including cataract extraction), retinal detachment/repair, and clinically significant lens opacity is acceptable for inclusion in the study. * Evidence of glaucoma regardless of medication regimen or control, an IOP greater than 21 mmHg at screening or propensity for narrow angle glaucoma. * NOTE: Phase I subjects with end-stage glaucoma and completely extinguished visual field are eligible to participate in the study. * Evidence of keratoconus, pellucid marginal degeneration, corneal dystrophy or irregularity, unstable (distorted/not clear) corneal mires on central keratometry images, corneal edema, corneal lesion, hypotony, or abnormal topography. Corneal thickness less than 470 microns at the thinnest point * Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course. * Either eye does not meet all inclusion criteria and does not fall within approved indications for treatment using femtosecond or excimer Laser. Not applicable for phase I subjects. * Desire for monovision correction. Not applicable for phase I subjects. * Women who are pregnant, breast-feeding, or intend to become pregnant during the study. * Participation in any other clinical study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Astigmatism are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Centre For Sight

    New Delhi, National Capital Territory of Delhi, 110075, India

  • Centro Oculistico Bresciano

    Brescia, 25122, Italy

  • Narayana Nethralaya Eye Hospital

    RajajiNagar, Bangalore, 560010, India

  • Singapore Eye Research Institute

    Singapore, 168753, Singapore

  • Svjetlost Eye Clinic

    Zagreb, City of Zagreb, 10000, Croatia

  • Tan Tock Seng Hospital PTE. LTD.

    Singapore, 308433, Singapore

More trials for these conditions

Other studies related to the condition(s) this trial covers.