Post-Market Clinical Follow-Up Study on the Rotational Stability of an Intraocular Lens After Cataract Surgery

NCT07099079 | Not Yet Recruiting

• 1 other identifier: HRSS-2025-01
• Study Type: observational
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IOL, Cataract

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoints - IOL axis misalignment

  Percentage of RayOne Model RAO800S IOLs with IOL axis misalignment 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.

  120 to 150 days post-operatively (Visit 4)

Secondary Outcomes (2)

• Secondary Effectiveness Endpoints - Stability of IOL axis orientation

  120 to 150 days post-operatively (Visit 4)

• Secondary Safety Endpoints - Rate of CDVA 0.30 logMAR

  120 to 150 days post-operatively (Visit 4)

Study Arms (1)

Cataract patients

Adult patients scheduled for routine bilateral cataract surgery as part of their standard clinical care. All participants receive the RayOne RAO800S non-toric monofocal intraocular lens with orientation marks.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 22 years or older who are scheduled for bilateral cataract surgery as part of routine clinical care and are in accordance with the study's inclusion and exclusion criteria.

You may qualify if:

• 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.
• 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.
• 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

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 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)
• Subjects with clinically significant corneal pathology, potentially affecting corneal topography
• Subjects with traumatic cataract in any eye
• Currently participating in a drug or device clinical trial, or having participated in such a trial within 30 days prior to the pre-operative visit
• Subjects with any other serious ocular pathology (e.g. 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
• Clinically significant, uncontrolled glaucoma with expected negative impact on IOL Rotational Stability and / or visual acuity outcomes in one or both eyes
• 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
• Pre-operative corneal astigmatism above 1.25D as determined by keratometry
• Irregular astigmatism in any eye

Sponsors & Collaborators

• Rayner Intraocular Lenses Limited: lead

MeSH Terms

Conditions

Intraocular Lymphoma; Cataract

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Eye Neoplasms; Neoplasms by Site; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lens Diseases; Eye Diseases

Central Study Contacts

Pavel Stodulka, MD, PhD, FEBOS-CR

CONTACT

+420 577 202 2; stodulka@lasik.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 1, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07