Post-Market Clinical Follow-Up Study on the Rotational Stability of an Intraocular Lens After Cat… (NCT07099079) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-Market Clinical Follow-Up Study on the Rotational Stability of an Intraocular Lens After Cataract Surgery
92 participantsStarted 2026-01-01
Plain-language summary
The goal of this post-market, prospective study at multiple clinics is to evaluate the rotational stability of the RayOne Model RAO800S non-toric monofocal intraocular lens with orientation marks in adult patients undergoing cataract surgery in both eyes. The main question it aims to answer is how stable the RayOne RAO800S lens is approximately 5 months (120 to 150 days) after surgery day. Participants are adults already scheduled to undergo cataract surgery as part of clinical routine. They will be asked to attend regular follow-up visits at the clinic, where eye images will be taken to assess the rotational stability of the implanted lens.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Male or female, 22 years or older at the pre-operative visit who have cataract in both eyes and 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 in both eyes after IOL implantation by investigator estimation
✓. Clear intraocular media other than cataract
✓. Contact lens wearers must demonstrate stability of biometry in both eyes
✓. Have the capability to understand and sign an EC approved informed consent form and privacy authorization in accordance with local regulations
✓. Female subjects must be 1-year postmenopausal, surgically sterilized, or if childbearing potential must use a stabilized and acceptable form of contraception from the beginning throughout the end of the study.
✓. Have pre-existing corneal astigmatism not exceeding 1.25 D in both eyes as determined by keratometry
✓. Dilated pupil size 5.5 mm or greater to allow visualization of the IOL orientation marks post-operatively in both eyes
Exclusion criteria
✕. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK / LASEK / PRK, SMILE, astigmatic keratotomy and limbal relaxing incisions in any 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 any eye
✕. Potentially occludable angle or ciliary body tumor, or other pathology that might increase risk to subject safety, based on adequate diagnostics e.g. gonioscopic, anterior OCT observation
✕. Subjects reasonably expected to require secondary ocular surgical intervention or laser treatment (other than YAG capsulotomy)