Cataract and IOL SurgeryCLAYRENCT07158177
Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity
A study testing Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company. and Clareon Panoptix in people with Cataract and IOL Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract and IOL Surgery
- What is being tested?
- Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company. and Clareon Panoptix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Patients presenting for cataract surgery in routine clinical practice and eligible for multifocal IOL implantation (toric and non-toric)
- Patients with grade 2/3 cataract density and comparable visual acuity in both eyes
- Patient with a pregnancy test (negative pregnancy test), if applicable
- Patient with signed consent to participate in the study
- Patient affiliated to a social security scheme or entitled beneficiary
Who cannot join
- Children < 18 years of age
- Pregnancy or breast-feeding in progress or planned during the study.
- History of anterior (cornea, anterior chamber, sulcus) or posterior (uveal, vitreoretinal) segment pathology, including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, AMD, glaucoma.
- Any inflammation of the anterior or posterior segment, whatever the etiology, and/or history of any disease with intraocular inflammatory repercussions.
- Clinically significant corneal pathology (epithelial, stromal and/or endothelial) that could have an impact on visual results.
- Clinically significant moderate or severe dry eye that could affect study measurements.
Show all 13Show fewer
- History of intraocular or corneal surgery (refractive or trauma-related).
- Presence or history of amblyopia or monofixation syndrome.
- Subjects with conditions that increase the risk of zonular disruption during the phacoemulsification procedure that may affect the centration or postoperative orientation of the IOL.
- Any other planned eye surgery, including, but not limited to, limbal relaxing incision (LRI)/astigmatic keratotomy and laser refractive surgery (LASIK).
- Irregular astigmatism identified by corneal topography
- Patients under guardianship, curatorship or safeguard of justice, as well as pregnant or breast-feeding women (article L1121-5 of the CSP).1.1
- Patient under AME
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valérie PLENCE, MSc contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris, Ophtalomopôle - Hôpital COCHIN
Paris, Île-de-France Region, 75014
Dominique MONNET, MD, PhD, 01 58 41 22 01 ext. +33, dominique.monnet@aphp.fr
About this study
Official title: Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity. Study of Two Different Material of Intra Ocular Multifocal Lenses Aiming to Compare the Effect on Contrast Sensitivity.
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.
Read the detailed description
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).
- Conditions
- Cataract and IOL Surgery
- Being tested
- Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company., Clareon Panoptix
- Keywords
- Multifocal Intra Ocular Lens, Presbyopia Correcting Intra Ocular Lens (PCIOL)., Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Clareon PanoptixDevice
both of the patient's eyes will be implanted: 1 CPO and the other APO
| Study group | Role | What they receive |
|---|---|---|
| Clareon™ PanOptix™, toric or no-toc | Experimental | Not described Receives: Device: Clareon Panoptix |
| AcrySof™ IQ PanOptix™, toric or no-toric | Active comparator | Not described Receives: Device: Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Contrast sensitivity measured at 3 months
AULCSF monocular in photopic condition with and without glareat 3 months.
Measured: 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)
UDVA, UIVA, UNVA, BCDVA, DCIVA, DCNVA
Measured: 3 months
Refractive stability
Comparison of refractive error between 1 and 3 months
Measured: 1 and 3 months
OSI : Objective Scatter Index: monocular
Comparison of refractive error between 1 and 3 months
Measured: 3 months
Glistenings
Using Miyata scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract and IOL SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dominique MONNET, MD, PhD, Principal investigator, Université Paris Cité, Faculté de Santé / UFR de médecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158177
- Sponsor's protocol ID
- APHP241077
- Other IDs
- IDRCB
- Acronym
- CLAYRE
- Status last verified
- Mar 2026
- First submitted
- 28 Aug 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity. Study of Two Different Material of Intra Ocular Multifocal Lenses Aiming to Compare the Effect on Contrast Sensitivity.
- ClinicalTrials.gov ID
- NCT07158177
- Acronym / sponsor ID
- CLAYRE / APHP241077
- Conditions
- Cataract and IOL Surgery
- Keywords
- Multifocal Intra Ocular Lens, Presbyopia Correcting Intra Ocular Lens (PCIOL)., Cataract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Alcon Research, URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon™ PanOptix™, toric or no-toc | Experimental | Device: Clareon Panoptix |
| AcrySof™ IQ PanOptix™, toric or no-toric | Active comparator | Device: Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years of age
- Patients presenting for cataract surgery in routine clinical practice and eligible for multifocal IOL implantation (toric and non-toric)
- Patients with grade 2/3 cataract density and comparable visual acuity in both eyes
- Patient with a pregnancy test (negative pregnancy test), if applicable
- Patient with signed consent to participate in the study
Key exclusion criteria (13 listed)
- Children < 18 years of age
- Pregnancy or breast-feeding in progress or planned during the study.
- History of anterior (cornea, anterior chamber, sulcus) or posterior (uveal, vitreoretinal) segment pathology, including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, AMD, glaucoma.
- Any inflammation of the anterior or posterior segment, whatever the etiology, and/or history of any disease with intraocular inflammatory repercussions.
- Clinically significant corneal pathology (epithelial, stromal and/or endothelial) that could have an impact on visual results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company.both of the patient's eyes will be implanted: 1 CPO and the other APO | Device | AcrySof™ IQ PanOptix™, toric or no-toric |
| Clareon Panoptixboth of the patient's eyes will be implanted: 1 CPO and the other APO | Device | Clareon™ PanOptix™, toric or no-toc |
Primary outcome
Contrast sensitivity measured at 3 months
Time frame: 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.
5 secondary outcomes
Contrast sensitivity measured at 3 months
Time frame: 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)
Time frame: 3 months
Refractive stability
Time frame: 1 and 3 months
OSI : Objective Scatter Index: monocular
Time frame: 3 months
Glistenings
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Cataract and IOL Surgery
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Not yet recruitingObservational study
Post-Market Clinical Follow-Up Study on the Rotational Stability of an Intraocular Lens After Cataract Surgery
IOL, Cataract
RecruitingObservational study
Postoperative Outcomes of a Toric AddOn Intraocular Lens After Keratoplasty and Cataract Surgery
Cataract and IOL Surgery, Keratoplasty
Active, not recruitingObservational study
Diabetic Nephropathy, Glycemic Control and Pseudophakic Macular Edema After Cataract Surgery
Pseudophakic Macular Edema, Diabetic Nephropathies
Not yet recruiting
Partial Range Of Field IOLs in DMEK-Enabled Procedures
Cataract, Fuchs Endothelial Corneal Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie PLENCE, MSc contact
Dominique MONNET, MD, PhD principal investigator
Université Paris Cité, Faculté de Santé / UFR de médecine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company. and Clareon Panoptix in people with Cataract and IOL Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique MONNET, MD, PhD (01 58 41 22 01 ext. +33, dominique.monnet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast sensitivity measured at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.