Clinical Trial of a Hydrophilic EMV Toric Lens RAO210T in the Correction of Aphakia and Corneal A… (NCT05985304) | Clinical Trial Compass
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 range22 Years
SexALL
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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.
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Mean Magnitude of Residual Manifest Cylinder
Timeframe: 120 to 180 days post-operatively
2
Adjusted Mean Difference Magnitude of Residual Manifest Cylinder
Timeframe: 120 to 180 days post-operatively
3
Axis Misalignment (Frequency and Percentage 10 Degrees)
Timeframe: 120 to 180 days post-operatively
4
Axis Misalignment (Frequency and Percentage 20 Degrees)
Timeframe: 120 to 180 days post-operatively
5
Stability of Toric IOL Axis Orientation (Frequency and Percentage)
Timeframe: 30 to 60 days and 120 to 180 days post-operatively
6
Rates of IOL Adverse Events Per ISO 11979-7
Timeframe: 120 to 180 days post-operatively
7
Rates of All Other Adverse Events Not Included in ISO 11979-7
Timeframe: 120 to 180 days post-operatively
8
Rates of Secondary Surgical Interventions for IOL Repositioning Due to IOL Misalignment
. 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)