NCT06327347

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jul 2022Jul 2026

Study Start

First participant enrolled

July 17, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

3.7 years

First QC Date

March 18, 2024

Last Update Submit

March 18, 2024

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Binocular Distance Corrected Intermediate Visual Acuity

    The primary endpoint is Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions minimum 1-month post-operative by a blinded evaluator

    one month

Study Arms (2)

ARTIS SYMBIOSE

ACTIVE COMPARATOR

25 patients will be implanted bilaterally with Artis Symbiose IOLs (Cristalens Industrie, France) . The device is CE-marked and used according to the intended purpose.

Device: intraocular lens implantation in cataract surgery

PANOPTIX

ACTIVE COMPARATOR

25 patients will be implanted bilaterally with AcrySof IQ PanOptix IOLs (Alcon, Switzerland).The device is CE-marked and used according to the intended purpose.

Device: intraocular lens implantation in cataract surgery

Interventions

intraocular lens implantation in cataract surgeryDEVICE

Implantation of intra ocular lenses in both patient's eyes in remplacement of the natural cataracted cristallin that has been removed from the patient's eye during the cataract surgery

ARTIS SYMBIOSEPANOPTIX

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< 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.
  • 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
  • +5 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heidelberg, Germany

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Lens Implantation, IntraocularCataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Sylvie Lebeau

CONTACT

+33 (0)2 96 48 92 92s.lebeau.ci@cristalens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative is perforemd by a blinded evaluator.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignement
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

July 17, 2022

Primary Completion

March 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)