Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
NCT06327347

Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

Led by Cristalens Industrie · Updated on 2024-03-25

50

Participants Needed

1

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator. This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint. The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent. Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits.

CONDITIONS

Official Title

Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 85 years old
  • Bilateral age-related cataract
  • Signed informed consent to participate in the study
  • Availability, willingness, and sufficient cognitive ability to follow study procedures
  • No previous refractive or ocular surgery
  • Need for intraocular lens in diopter range of 10 to 30 D
  • Expected postoperative astigmatism of 0.75 D or less
  • Eye dryness severity grading score of 2 or less
  • For women of childbearing potential: willing to use adequate contraception
Not Eligible

You will not qualify if you...

  • Being under legal guardianship or curatorship
  • Illiteracy or insufficient knowledge of the German language
  • Acute or chronic disease increasing risk or affecting study results as judged by investigators
  • Pupil size larger than 4 mm or smaller than 2 mm in bright light
  • Pupil abnormalities such as non-reactive, tonic, abnormally shaped, or non-dilating under dim light
  • Occupation requiring night-time driving or incompatible with multifocal lenses
  • Amblyopia, strabismus, or color blindness
  • Extremely shallow anterior chamber
  • Capsule or zonular abnormalities affecting lens position (e.g., pseudoexfoliation syndrome, uveitis, Marfan's syndrome)
  • Irregular astigmatism or unstable cornea
  • Pregnant or breastfeeding women or women of childbearing potential not using contraception
  • Withdrawal of patient consent
  • Inability to safely place the intraocular lens at planned location
  • Surgical complications such as non-circular or improper sized rhexis preventing implantation with study lens

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)

Heidelberg, Germany

Actively Recruiting

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Research Team

S

Sylvie Lebeau

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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