New lens implant tackles cataracts and astigmatism in one surgery
NCT ID NCT05985304
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
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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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274 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Oct 2024
- 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. 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
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Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464, United States
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Cleveland Eye Clinic
Avon, Ohio, 44011, United States
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ICON Eyecare
Grand Junction, Colorado, 81501, United States
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Moyes Eye Center
Kansas City, Missouri, 64154, United States
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Parkhurst NuVision
San Antonio, Texas, 78229, United States
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Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
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Vance Thompson Vision Alexandria
Alexandria, Minnesota, 56308, United States
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Vance Thompson Vision North Dakota
West Fargo, North Dakota, 58078, United States
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Vold Vision
Fayetteville, Arkansas, 72704, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- One operation for cataract and glaucoma? eye surgeons test a Two-in-One approach
- Eye drops may shield the cornea after cataract surgery
- A simple blood draw might reveal hidden eye lymphoma
- Can a new lens make glasses obsolete after cataract surgery?
- Can a new lens design sharpen vision after macular surgery?