IOL, Cataract
Conditions
Brief 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.
Detailed description
This post-market clinical follow-up (PMCF) study is a prospective, multicenter investigation in European sites. It evaluates the rotational stability of the RayOne Model RAO800S, a non-toric monofocal intraocular lens with orientation marks, following bilateral implantation. Participants will be assessed approximately 5 months (120 to 150 days) post-operatively.
Interventions
None listed
Sponsors
Rayner Intraocular Lenses Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Inclusion criteria
Eligible subjects must meet all the following inclusion criteria in both eyes. 1. 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 2. 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 3. Clear intraocular media other than cataract 4. Contact lens wearers must demonstrate stability of biometry in both eyes 5. Have the capability to understand and sign an EC approved informed consent form and privacy authorization in accordance with local regulations 6. 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. Stabilized and acceptable contraception methods include at least one of the following: intrauterine (intrauterine device) or hormonal (oral, injection, patch, implant, ring) for at least 3 months, barrier with spermicide (condom, diaphragm), or abstinence. 7. Have pre-existing corneal astigmatism not exceeding 1.25 D in both eyes as determined by keratometry 8. Dilated pupil size 5.5 mm or greater to allow visualization of the IOL orientation marks post-operatively in both eyes Eligible subjects must not meet any of the following
Exclusion criteria
. Subjects may not participate if either eye meets any of the ocular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint - IOL rotation | 120 to 150 days post-operatively (Visit 4) | Percentage of RayOne Model RAO800S IOLs with IOL rotation at Visit 4 (as determined by photographic method using baseline image at day of surgery) less than * 10 degrees in 90% of the cases as described in ISO 11979-7:2024. * 20 degrees in 95% of the cases as described in ISO 11979-7:2024. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoints - Stability of IOL axis orientation | 120 to 150 days post-operatively (Visit 4) | Stability of IOL axis orientation, expressed as percentage of IOLs that rotate ≤ 5 degrees postoperatively between 30 to 60 days (Visit 3) and 120 to 150 days (Visit 4) as described in the ANSI Z80.30-2018. This criterium is passed if 90% of the IOLs in the treated eyes rotate ≤ 5 degrees between the mentioned visits. |
| Secondary Effectiveness Endpoints - Axis misalignment | 120 to 150 days post-operatively (Visit 4) | Axis misalignment, defined as the absolute difference between intended IOL axis orientation and Visit 4, (as determined by photographic method using baseline image at the day of surgery) shall be less than * 10 degrees in 90% of the cases as described in ANSI Z80.30-2018 * 20 degrees in 95% of the cases as described in ANSI Z80.30-2018. |
| Secondary Safety Endpoints - Rate of CDVA 0.30 logMAR | 120 to 150 days post-operatively (Visit 4) | Rate of CDVA 0.30 logMAR or better at 120 to 150 days post-operatively (Visit 4) shall not exceed the ISO SPE threshold rates as described in ISO 11979-7:2024 (Table E.3) |
Contacts
CONTACTPavel Stodulka, MD, PhD, FEBOS-CR
Outcome results
None listed