- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327347
Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg (C2H)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This trial is a single center, prospective, randomized (1:1), unblinded, controlled study conducted in Germany according to Art. 82 MDR (PMCF study).
The lead investigator at the Heidelberg Eye University Hospital - International Vision Correction Research Centre (IVCRC) is Pr. Gerd Auffarth.
This study examines the visual performance of the two IOLs involved : Artis Symbiose (study lenses) compared to PanOptix (comparator) in bilaterally implanted patients.
The aim of this comparative study is to assess the performance and safety of these two IOLs with targeting to demonstrate the superiority of Artis Symbiose in some specific performance parameters. The tested hypothesis is the superiority of Artis Symbiose over PanOptix IOLs on the primary evaluation criterion.
A total of 50 patients will be included at one investigational center. Subjects participating in the study will attend a maximum of 5 study visits (1 preoperative, 1 operative and 3 postoperative visits) over a period of 12 months.
Only patients who have age-related cataracts will be included in the study. To participate in this study, patients must be at least 50 years old at the time of screening and maximum 85 years old. All patients who would like to take part in this study will receive a detailed study information by the investigator staff and a written informed form. Before a patient is admitted, he or she must sign a consent form.
The primary study endpoint is to compare the performance of 2 IOLs (Artis Symbiose, and PanOptix) 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.
The entire study including data processing will be carried out in accordance with EN ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects, EN ISO 11979-7:2018: Clinical investigations of intraocular lenses for the correction of aphakia, EU MDR 2017/745, MEDDEV 2.7.1 rev. 4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, MPDG:2020: Medical Device Law Implementation Act, as well as applicable local regulations and the Declaration of Helsinki.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sylvie Lebeau
- Phone Number: +33 (0)2 96 48 92 92
- Email: s.lebeau.ci@cristalens.fr
Study Locations
-
-
-
Heidelberg, Germany
- Recruiting
- Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
-
Contact:
- Raquel Willrich Amroussi
- Phone Number: +49 6221 56-36849
- Email: raquel.willrichamroussi@med.uni-heidelberg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ARTIS SYMBIOSE
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.
|
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
|
Active Comparator: PANOPTIX
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binocular Distance Corrected Intermediate Visual Acuity
Time Frame: one month
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-05_C2H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cataract
-
Fundación Pública Andaluza para la Investigación...CompletedCataract | Cataract Mature | Cataract, Nuclear
-
Johannes Kepler University of LinzCompletedCataract Complicated | Cataract Complications OperationsAustria
-
Gemini Eye ClinicRecruitingBilateral Cataract | Unilateral CataractCzechia
-
Universitaire Ziekenhuizen KU LeuvenLaboratoires TheaRecruiting
-
Omer Othman AbdullahCompletedCongenital Cataract | Pediatric CataractIraq
-
Johannes Kepler University of LinzRecruitingAphakia | Secondary Cataract Surgery | Complicated Cataract SurgeryAustria
-
Yonsei UniversityCompletedCataract PatientsKorea, Republic of
-
Advanced Center for Eyecare GlobalNot yet recruiting
-
Vienna Institute for Research in Ocular SurgeryRecruiting
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNot yet recruitingCataract ExtractionChina
Clinical Trials on intraocular lens implantation in cataract surgery
-
Cristalens IndustrieRecruiting
-
Iladevi Cataract and IOL Research CenterCompletedPostoperative Complications | Posterior Capsule Opacification
-
Federal University of Minas GeraisCompletedCataract | Lens Diseases | Signs and Symptoms | PseudophakiaBrazil
-
The University of Hong KongJanssen, LPNot yet recruiting
-
Clínica RementeríaAlcon ResearchCompleted
-
Taipei Nobel Eye ClinicCompletedCataract SenileTaiwan
-
Hanita LensesCompleted
-
Medical University of ViennaCompletedCataract | PseudophakiaAustria
-
Clínica RementeríaRecruitingLenses, IntraocularSpain
-
Kasr El Aini HospitalCompletedLenses, IntraocularEgypt