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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2025-A00658-41 |
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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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Retrospective, comparative, interventional, randomized, single-center study, contralateral (the patient's 2 eyes will be implanted: 1 CPO and the other APO) Patients presenting for cataract surgery with a request for presbyopia correction and managed as part of routine clinical practice.
The main aim of the study is to demonstrate that contrast sensitivity is better with the Clareon PanOptix (CPO) intraocular lens (IOL) compared with the AcrySof PanOptix (APO) IOL 3 months after implantation.
Visit at Day3-10: usual follow-up visit, no additional examinations as part of the clinical investigation.
Visit at 1 month: usual follow-up visit, no additional examinations as part of the clinical investigation.
3-month visit (end of clinical investigation): usual follow-up visit, plus contrast vision test and non-invasive aberrometry test (I-Trace) as part of the clinical investigation.
Regarding a cataract surgery with a request for presbyopia, the protocol evaluate two differents devices (IOL intraocular lens).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon™ PanOptix™, toric or no-toc | Experimental |
| |
| AcrySof™ IQ PanOptix™, toric or no-toric | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company. | Device | both of the patient's eyes will be implanted: 1 CPO and the other APO |
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| Measure | Description | Time Frame |
|---|---|---|
| Contrast sensitivity measured at 3 months | AULCSF (Area under the log contrast sensitivity function) at different spatial frequencies (1,5 ; 3 ; 6 ; 12 cycles par degré (cpd)) in monocular vision and under mesopic condition without glare. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast sensitivity measured at 3 months | AULCSF monocular in photopic condition with and without glareat 3 months. | 3 months |
| Uncorrected and corrected Visual acuity (UCVA and CVA) or in monocular and binocular vision at different distances (4 meters for Distance- 66 centimeters of intermediate- 40 cm for Near) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique MONNET, MD, PhD | Contact | 01 58 41 22 01 | +33 | dominique.monnet@aphp.fr |
| Valérie PLENCE, MSc | Contact | valerie.plence-fauroux@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dominique MONNET, MD, PhD | Université Paris Cité, Faculté de Santé / UFR de médecine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - HĂ´pitaux de Paris, OphtalomopĂ´le - HĂ´pital COCHIN | Recruiting | Paris | ĂŽle-de-France Region | 75014 | France |
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| Label | URL |
|---|---|
| This web link leads to the website of SAFIR, which is a French learned society dedicated to refractive and cataract surgery with implants. It contains an educational section on multifocal implants and cataract surgery to better understand the protocol. | View source |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Clareon Panoptix | Device | both of the patient's eyes will be implanted: 1 CPO and the other APO |
|
UDVA, UIVA, UNVA, BCDVA, DCIVA, DCNVA |
| 3 months |
| Refractive stability | Comparison of refractive error between 1 and 3 months | 1 and 3 months |
| OSI : Objective Scatter Index: monocular | Comparison of refractive error between 1 and 3 months | 3 months |
| Glistenings | Using Miyata scale | 3 months |