CompletedNot Applicable

Clinical Trial of a Hydrophilic EMV Toric Lens RAO210T in the Correction of Aphakia and Corneal Astigmatism

United States274 participantsStarted 2023-08-10

Plain-language summary

The objectives of the clinical investigation are to determine the safety and performance of the RayOne EMV Toric (Model RAO210T) following unilateral implantation and approximately 6 months (120 to 180 days) of post-operative assessment, as a randomized comparison to aspheric monofocal control for low cylinder (1.50 D). This patient population with cataracts and low corneal cylinder (+1.00 to +1.50 D) will have the natural crystalline lens removed and replaced with an intraocular lens in the capsular bag.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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
. Clear intraocular media other than cataract
. Contact lens wearers must demonstrate stability of biometry
. Have the capability to understand and sign an IRB approved informed consent form and privacy authorization in accordance with local regulations
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested the RAO210T toric lens specifically for correcting both cataracts and corneal astigmatism at the same time — is that a combination I actually have, and would a toric IOL like this one be appropriate for my situation compared to a standard lens?
2The trial tracked how often the lens rotated out of its intended position after implantation, and whether patients needed a second surgery to reposition it — based on the results of this study, how does that repositioning rate compare to other toric lenses you've used or considered for me?
3One of the key things this trial measured was how much astigmatism was left over after surgery — given my current level of corneal astigmatism, what level of residual astigmatism should I realistically expect, and how might that affect my vision day-to-day?
4The trial measured whether patients reached a vision level of 0.30 logMAR or better after surgery — what does that mean in practical terms for me, and is that the level of vision improvement I should be aiming for with my specific eye health?
5Since this trial has already been completed, are its results published or available yet, and would those findings change your recommendation about which IOL is the best fit for my cataract surgery?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Magnitude of Residual Manifest Cylinder

Timeframe: 120 to 180 days post-operatively

Adjusted Mean Difference Magnitude of Residual Manifest Cylinder

Timeframe: 120 to 180 days post-operatively

Axis Misalignment (Frequency and Percentage 10 Degrees)

Timeframe: 120 to 180 days post-operatively

Axis Misalignment (Frequency and Percentage 20 Degrees)

Timeframe: 120 to 180 days post-operatively

Stability of Toric IOL Axis Orientation (Frequency and Percentage)

Timeframe: 30 to 60 days and 120 to 180 days post-operatively

Rates of IOL Adverse Events Per ISO 11979-7

Timeframe: 120 to 180 days post-operatively

Rates of All Other Adverse Events Not Included in ISO 11979-7

Timeframe: 120 to 180 days post-operatively

Trial details

NCT IDNCT05985304

SponsorRayner Intraocular Lenses Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-23

Results submitted2025-10-31

View on ClinicalTrials.gov More Cataract trials

Plain-language summary

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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
. Clear intraocular media other than cataract
. Contact lens wearers must demonstrate stability of biometry
. Have the capability to understand and sign an IRB approved informed consent form and privacy authorization in accordance with local regulations
. 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.

What they're measuring

Mean Magnitude of Residual Manifest Cylinder

Timeframe: 120 to 180 days post-operatively

Adjusted Mean Difference Magnitude of Residual Manifest Cylinder

Timeframe: 120 to 180 days post-operatively

Axis Misalignment (Frequency and Percentage 10 Degrees)

Timeframe: 120 to 180 days post-operatively

Axis Misalignment (Frequency and Percentage 20 Degrees)

Timeframe: 120 to 180 days post-operatively

Stability of Toric IOL Axis Orientation (Frequency and Percentage)

Timeframe: 30 to 60 days and 120 to 180 days post-operatively

Rates of IOL Adverse Events Per ISO 11979-7

Timeframe: 120 to 180 days post-operatively

Rates of All Other Adverse Events Not Included in ISO 11979-7

Timeframe: 120 to 180 days post-operatively

Clinical Trial of a Hydrophilic EMV Toric Lens RAO210T in the Correction of Aphakia and Corneal Astigmatism

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Clinical Trial of a Hydrophilic EMV Toric Lens RAO210T in the Correction of Aphakia and Corneal Astigmatism

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria