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New lens implant tackles cataracts and astigmatism in one surgery

NCT ID NCT05985304

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a special toric lens implant (RayOne EMV Toric) in 274 adults with cataracts and mild corneal astigmatism. Participants had cataract surgery and received either the toric lens or a standard monofocal lens. The goal was to see if the toric lens safely reduces blur from astigmatism better than a standard lens. Results showed the toric lens effectively lowered residual astigmatism with good safety over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RayOne EMV Toric intraocular lens (a special lens implant for the eye)
What this could lead to
If successful, this lens could give people with cataracts and mild astigmatism clearer distance vision without needing glasses after surgery.
What could go wrong
This is a completed trial, but the lens only corrects low astigmatism and may not work for everyone. Some patients may still need glasses or have lens rotation.

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

274 people

The number who actually took part.

Started

Aug 2023

Finished

Oct 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

22 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: 1. Male or female, 22 years or older at the pre-operative visit who have cataract with best corrected distance visual acuity of 0.30 logMAR (20/40) or worse in at least one eye with or without a glare source present who are eligible for phacoemulsification cataract surgery 2. Subjects who are projected to have best corrected distance visual acuity 0.20 logMAR (20/30) or better after IOL implantation by potential acuity meter (PAM) or Investigator estimation 3. Clear intraocular media other than cataract 4. Contact lens wearers must demonstrate stability of biometry 5. Have the capability to understand and sign an IRB approved informed consent form and privacy authorization in accordance with local regulations 6. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Pre-operative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. 7. Have Investigator selected IOL spherical equivalent power between +10.0 D to +25.0 D in 0.5 D steps and IOL cylinder power of +1.50 D 8. Have pre-existing corneal astigmatism of 1.00 D to 1.50 D as determined by keratometry 9. Dilated pupil size 5.5 mm or greater to allow visualization of the toric IOL axis markings post-operatively Exclusion Criteria: 1. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK / LASEK / PRK, SMILE, astigmatic keratotomy and limbal relaxing incisions in the planned operative eye. 2. Diagnosed degenerative visual disorders (e.g. macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) that are predicted to cause future acuity losses to a level of 0.20 logMAR (20/30) or worse 3. Significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g. pseudoexfoliation syndrome, any iris pathology) 4. Subjects with conditions associated with increased risk of zonular rupture (that may affect post-operative centration or tilt of IOL) in the planned operative eye 5. Potentially occludable angle or ciliary body tumor, or other pathology that might increase risk to subject safety, based on gonioscopic observation 6. Subjects reasonably expected to require secondary ocular surgical intervention or laser treatment (other than YAG capsulotomy) 7. Subjects with clinically significant corneal pathology, potentially affecting corneal topography 8. Subjects with traumatic cataract in the planned operative eye 9. Participating in a concurrent drug or device clinical trial or who have participated in a drug or device trial within 30 days of the pre-operative visit 10. Subjects with any other serious ocular pathology (e.g. glaucoma, severe dry eye, history of intraocular inflammation, history of retinal surgery or retinal laser procedure) or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study (History of cataract surgery with PC-IOL in one eye is allowed.) 11. Use of medications known to interfere with visual performance, pupil dilation, or iris structure within 30 days of the pre-operative visit, at the discretion of the Investigator 12. Pregnant or nursing females 13. Irregular astigmatism in the planned operative eye

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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

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464, United States

  • Cleveland Eye Clinic

    Avon, Ohio, 44011, United States

  • ICON Eyecare

    Grand Junction, Colorado, 81501, United States

  • Moyes Eye Center

    Kansas City, Missouri, 64154, United States

  • Parkhurst NuVision

    San Antonio, Texas, 78229, United States

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108, United States

  • Vance Thompson Vision Alexandria

    Alexandria, Minnesota, 56308, United States

  • Vance Thompson Vision North Dakota

    West Fargo, North Dakota, 58078, United States

  • Vold Vision

    Fayetteville, Arkansas, 72704, United States

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