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 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 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.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
. 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)