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

Completed · Not applicable

Conditions studied: Cataract, Corneal Astigmatism

In brief

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.

Key facts

Study ID

NCT05985304

Run by

Rayner Intraocular Lenses Limited

People needed

274

Starts

2023-08-10

Expected to finish

2024-10-23

Last updated by the study team

2026-01-21

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Vold Vision — Fayetteville, Arkansas, United States
• ICON Eyecare — Grand Junction, Colorado, United States
• Vance Thompson Vision Alexandria — Alexandria, Minnesota, United States
• Moyes Eye Center — Kansas City, Missouri, United States
• Vance Thompson Vision North Dakota — West Fargo, North Dakota, United States
• Cleveland Eye Clinic — Avon, Ohio, United States
• Carolina Eyecare Physicians — Mt. Pleasant, South Carolina, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States
• Parkhurst NuVision — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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