Proof-of-concept Study for a New Intraocular Lens, MODEL C0001
Primary Purpose
Cataract
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Model C0001
Model ZCB00
Sponsored by
About this trial
This is an interventional other trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Age of study population between 60-75 years;
- Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned for both eyes;
- Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms in the opinion of the investigator;
- Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better;
- Drives a car at least 1-2 times per month;
Corneal astigmatism:
- Normal corneal topography
- Predicted postoperative residual refractive cylinder based on a toric IOL calculator, taking surgically induced astigmatism (SIA) into account and using the posterior corneal astigmatism (PCA) option, must be less than 1.00 D in both eyes.
- Clear intraocular media other than cataract in each eye;
- Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
- Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
- Ability to understand, read and write in French.
Exclusion Criteria:
- Requiring an intraocular lens power needed to achieve emmetropia (spherical equivalent ± 0.50 D) outside the available range of +18.0 D to +30.0 D for the Model C0001 IOL or +16.0 D to +28.0 D for the Model ZCB00 IOL;
- Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils);
- Irregular corneal astigmatism;
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery;
- Subjects who may be expected to require retinal laser treatment during the study;
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
- Inability to achieve keratometric corneal stability preoperatively as a result of recent contact lens usage;
- Subjects with diagnosed degenerative visual disorders (e.g., retinal disorders such as macular degeneration) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
- Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects;
- Use of systemic or ocular medications that may affect vision;
- Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- Poorly-controlled diabetes;
- Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.); NOTE: Controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
- Neurological or neurodegenerative disorders that affect locomotion and cognitive function (e.g., Muscular disorders, Parkinson's disease, Alzheimer's disease etc.);
- Use of mobility aids;
- Motion Sickness Susceptibility Questionnaire Short-form (MSSQ-Short) score of ≥ 25;
- Subject has condition(s) associated with the fluctuation of hormones that could lead to refractive changes;
- Concurrent participation in any other clinical trial or participation within 30 days prior to the preoperative visit.
Sites / Locations
- Centre Hospitalier National d'Ophtalmologie
- Rothschild Foundation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Lens
Control Lens
Arm Description
Model C0001
Model ZCB00
Outcomes
Primary Outcome Measures
MONOCULAR, PERIPHERAL REFRACTIVE ERROR
MONOCULAR, PHOTOPIC BCDVA AT 4 M
Adverse Events rates
Secondary Outcome Measures
Full Information
NCT ID
NCT05036070
First Posted
August 26, 2021
Last Updated
October 9, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05036070
Brief Title
Proof-of-concept Study for a New Intraocular Lens, MODEL C0001
Official Title
Proof-of-concept Study for a New Intraocular Lens, MODEL C0001
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a 12-month, prospective, 2-arm (1 test & 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL.
The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit.
The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Lens
Arm Type
Experimental
Arm Description
Model C0001
Arm Title
Control Lens
Arm Type
Active Comparator
Arm Description
Model ZCB00
Intervention Type
Device
Intervention Name(s)
Model C0001
Intervention Description
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Intervention Type
Device
Intervention Name(s)
Model ZCB00
Intervention Description
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Primary Outcome Measure Information:
Title
MONOCULAR, PERIPHERAL REFRACTIVE ERROR
Time Frame
1 month postoperative
Title
MONOCULAR, PHOTOPIC BCDVA AT 4 M
Time Frame
1 month postoperative
Title
Adverse Events rates
Time Frame
12 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of study population between 60-75 years;
Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned for both eyes;
Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms in the opinion of the investigator;
Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better;
Drives a car at least 1-2 times per month;
Corneal astigmatism:
Normal corneal topography
Predicted postoperative residual refractive cylinder based on a toric IOL calculator, taking surgically induced astigmatism (SIA) into account and using the posterior corneal astigmatism (PCA) option, must be less than 1.00 D in both eyes.
Clear intraocular media other than cataract in each eye;
Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
Ability to understand, read and write in French.
Exclusion Criteria:
Requiring an intraocular lens power needed to achieve emmetropia (spherical equivalent ± 0.50 D) outside the available range of +18.0 D to +30.0 D for the Model C0001 IOL or +16.0 D to +28.0 D for the Model ZCB00 IOL;
Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils);
Irregular corneal astigmatism;
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery;
Subjects who may be expected to require retinal laser treatment during the study;
Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
Inability to achieve keratometric corneal stability preoperatively as a result of recent contact lens usage;
Subjects with diagnosed degenerative visual disorders (e.g., retinal disorders such as macular degeneration) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects;
Use of systemic or ocular medications that may affect vision;
Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
Poorly-controlled diabetes;
Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.); NOTE: Controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
Neurological or neurodegenerative disorders that affect locomotion and cognitive function (e.g., Muscular disorders, Parkinson's disease, Alzheimer's disease etc.);
Use of mobility aids;
Motion Sickness Susceptibility Questionnaire Short-form (MSSQ-Short) score of ≥ 25;
Subject has condition(s) associated with the fluctuation of hormones that could lead to refractive changes;
Concurrent participation in any other clinical trial or participation within 30 days prior to the preoperative visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier National d'Ophtalmologie
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75012
Country
France
Facility Name
Rothschild Foundation Hospital
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
IPD Sharing URL
http://yoda.yale.edu
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Proof-of-concept Study for a New Intraocular Lens, MODEL C0001
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