Comparing two types of intraocular lenses for cataract surgery

Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

This study is testing which of two types of lenses used in cataract surgery helps people see better at a distance after their surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Cristalens Industrie (industry)
• Locations: 1 site (Heidelberg)
• Trial ID: NCT06327347 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the performance of two multifocal intraocular lenses (IOLs), ARTIS SYMBIOSE and PANOPTIX, in patients undergoing cataract surgery. The study will assess binocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm in photopic conditions, with evaluations conducted by a blinded evaluator at least one month post-surgery. A total of 50 patients aged 50 to 85 with bilateral age-related cataracts will participate in this single-center, randomized, controlled study at the Heidelberg Eye University Hospital. Participants will attend five study visits over a 12-month period to monitor their visual performance and safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 85 with bilateral age-related cataracts requiring surgery.

Not a fit: Patients with previous ocular surgeries or those with specific pupil abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved visual outcomes for patients undergoing cataract surgery.

How similar studies have performed: Previous studies comparing multifocal IOLs have shown varying degrees of success, making this approach both relevant and potentially impactful.

Eligibility 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 study procedures
* 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
* For women of childbearing potential: Willing to adhere to an adequate form of contraception.

Non-inclusion criteria :

* Being under guardianship / curatorship
* Illiterate or not enough knowledge of German 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
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic 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)
* Irregular astigmatism, unstable cornea
* Pregnant or women of childbearing potential or breastfeeding women

Exclusion Criteria:

* Patient consent withdrawal
* 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

Heidelberg

• Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC) — Heidelberg, Germany (RECRUITING)

Study contacts

• Study coordinator: Sylvie Lebeau

Conditions: Cataract