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

NCT05985304 | Completed Results FDA Device

• 1 other identifier: WR-2023-US-03
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Cataract; Corneal Astigmatism

Keywords

Toric Intraocular Lens

Outcome Measures

Primary Outcomes (9)

• Mean Magnitude of Residual Manifest Cylinder

  Mean magnitude of residual manifest cylinder (as measured by manifest refractive cylinder).

  120 to 180 days post-operatively

• Adjusted Mean Difference Magnitude of Residual Manifest Cylinder

  The adjusted mean difference of residual manifest cylinder (as measured by manifest refractive cylinder) between Toric and Monofocal groups will be given together with a 95% confidence interval and associated one-sided p-value. This endpoint will be considered successful if the one-sided p-value ≤ 0.025.

  120 to 180 days post-operatively

• Axis Misalignment (Frequency and Percentage 10 Degrees)

  Frequency and percentage of RayOne EMV Toric (Model RAO210T) IOLs with IOL axis misalignment at Visit 4 (as determined by photographic method) less than 10 degrees.

  120 to 180 days post-operatively

• Axis Misalignment (Frequency and Percentage 20 Degrees)

  Frequency and percentage of RayOne EMV Toric (Model RAO210T) IOLs with IOL axis misalignment at Visit 4 (as determined by photographic method) less than 20 degrees.

  120 to 180 days post-operatively

• Stability of Toric IOL Axis Orientation (Frequency and Percentage)

  Stability of toric IOL axis orientation, expressed as frequency and percentage of RayOne EMV Toric (Model RAO210T) IOLs that rotate ≤ 5 degrees postoperatively between 30 to 60 days (Visit 3) and 120 to 180 days (Visit 4)

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

• Rates of IOL Adverse Events Per ISO 11979-7

  Rates of IOL adverse events through 120 to 180 days post-operatively (Visit 4) compared to the ISO Safety and Performance Endpoint (SPE) rates as described in ISO 11979-7. Rates of cumulative and persistent adverse events from ISO 11979-7 (2018) Table E.2 will be reported by treatment group (Toric test group, Monofocal control group) and AE type. Rates of adverse events will be compared to the SPE rate from Table E.2. The one-sided p-value from the exact binomial test of each hypothesis will also be provided for each adverse event. If none of these hypothesis test results are statistically significant, this endpoint will be considered successful for the toric IOL.

  120 to 180 days post-operatively

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

  The eyes with at least one adverse event not included in the cumulative and persistent adverse events from ISO 11979-7 (2018) Table E.2 through 120 to 180 days post-operatively (Visit 4) will be presented by treatment group (Toric test group, Monofocal control group).

  120 to 180 days post-operatively

• Rates of Secondary Surgical Interventions for IOL Repositioning Due to IOL Misalignment

  The percentage of eyes implanted with the Toric test group IOL requiring a secondary surgical intervention for IOL repositioning due to IOL misalignment through 120 to 180 days post-operatively (Visit 4), as well as a two-sided 95% exact binomial confidence interval for the percentage, will be presented.

  120 to 180 days post-operatively

• Rate of BCDVA of 0.30 logMAR or Better Compared to the ISO SPE Rates

  The percentage of eyes that achieve a BCDVA at 4 meters of 0.30 logMAR or better at 120 to 180 days post-operatively (Visit 4) will be presented by treatment group (Toric test group, Monofocal control group) for the Safety Set and Best Case Set. If neither of these hypothesis test results are statistically significant, this endpoint will be considered successful for the toric IOL.

  120 to 180 days post-operatively

Secondary Outcomes (2)

• Residual Manifest Cylinder Stratified by Preoperative Keratometric Cylinder

  120 to 180 days post-operatively

• Percent Change in Absolute Cylinder Stratified by Preoperative Keratometric Cylinder

  120 to 180 days post-operatively

Study Arms (2)

Toric (test) group

EXPERIMENTAL

All subjects randomized to be implanted with the low cylinder (1.50 D) RayOne EMV Toric IOL (Model RAO210T)

Device: RayOne EMV Toric IOL; Procedure: Cataract Surgery

Monofocal (control) group

ACTIVE COMPARATOR

All subjects randomized to be implanted with the RAO600C Monofocal IOL

Device: RayOne Monofocal IOL; Procedure: Cataract Surgery

Interventions

RayOne EMV Toric IOL DEVICE

Implantation of intraocular lens.

Also known as: Model RAO210T

Toric (test) group

RayOne Monofocal IOL DEVICE

Implantation of intraocular lens.

Also known as: RAO600C

Monofocal (control) group

Cataract Surgery PROCEDURE

Removal of natural crystalline lens due to cataracts

Monofocal (control) group; Toric (test) group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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
• Have pre-existing corneal astigmatism of 1.00 D to 1.50 D as determined by keratometry
• Dilated pupil size 5.5 mm or greater to allow visualization of the toric IOL axis markings post-operatively

You may not qualify if:

• 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.
• 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
• Significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g. pseudoexfoliation syndrome, any iris pathology)
• 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
• Potentially occludable angle or ciliary body tumor, or other pathology that might increase risk to subject safety, based on gonioscopic observation
• Subjects reasonably expected to require secondary ocular surgical intervention or laser treatment (other than YAG capsulotomy)
• Subjects with clinically significant corneal pathology, potentially affecting corneal topography
• Subjects with traumatic cataract in the planned operative eye
• 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
• 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.)
• 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
• Pregnant or nursing females
• Irregular astigmatism in the planned operative eye

Sponsors & Collaborators

• Rayner Intraocular Lenses Limited: lead

Study Sites (9)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

ICON Eyecare

Grand Junction, Colorado, 81501, United States

Location

Vance Thompson Vision Alexandria

Alexandria, Minnesota, 56308, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Vance Thompson Vision North Dakota

West Fargo, North Dakota, 58078, United States

Location

Cleveland Eye Clinic

Avon, Ohio, 44011, United States

Location

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Senior Clinical Trial Manager
• Organization: Rayner Intraocular Lenses Limited

EricAlegria@rayner.com

714-398-9988

Study Officials

• Mark Packer, MD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 14, 2023
• Study Start: August 10, 2023
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after device approval in the US
• Access Criteria: To be determined by the study sponsor after device approval.

Locations

US (9)