Comparing three types of intraocular lenses for cataract surgery
Comparative Study of 3 Multifocal Intraocular Lenses in Murcia
This study is testing three different types of lenses for cataract surgery to see which one helps people see better after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Cristalens Industrie Industry-sponsored |
| Locations | 1 site (Murcia) |
| Trial ID | NCT06323915 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the performance of three multifocal intraocular lenses (IOLs) in patients undergoing cataract surgery. The study will evaluate the ARTIS SYMBIOSE lens against two comparators, FineVision and Tecnis Synergy, focusing on visual performance through binocular distance-corrected defocus curves. Approximately 84 patients aged 50 to 85 with bilateral age-related cataracts will participate, attending five study visits over 12 months. The trial is conducted at the Murcia Ircovision Eye Clinic in Spain and follows a randomized, controlled design.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 85 with bilateral age-related cataracts who require cataract surgery.
Not a fit: Patients with previous ocular surgeries, certain eye conditions, or those requiring night-time driving may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved visual outcomes for cataract patients through enhanced depth-of-field with the ARTIS SYMBIOSE lens.
How similar studies have performed: Other studies have shown success with multifocal IOLs, but this specific comparison of ARTIS SYMBIOSE with established lenses is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 50 \< Age \< 85 years old * Bilateral age-related cataract * Signed informed consent of the study * Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Qualify for bilateral implantation within 1 month * No previous refractive or ocular surgery * Need for IOL in this diopter range: 10 to 30 D * Expected postoperative astigmatism ≤ 0.75 D * Eye dryness ≤ 2 in dry eye severity grading Non-inclusion criteria: * Being under guardianship / curatorship * Illiterate or not enough knowledge of Spanish language * Acute or chronic disease or illness that would increase risk or confound study results found to be relevant by the investigators * Pupil \> 4mm or \< 2mm in photopic conditions * Occupation requiring night-time driving or any occupation incompatible with multifocality * Amblyopia, strabismus, color blindness * Extremely shallow anterior chamber * Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, uveitis, Marfan's syndrome). * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions). * Irregular astigmatism, unstable cornea. Exclusion Criteria: * Inability to place the intraocular lens safely at the location planned * Surgical complications (e.g. non-circular rhexis, oversized or undersized rhexis). Each patient with these intraoperative complications should not be implanted with the study IOL
Where this trial is running
Murcia
- Vista Clinic Ircovision Murcia — Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: Sylvie Lebeau
- Email: s.lebeau.ci@cristalens.fr
- Phone: +33 (0)2 96 48 92 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.