Clinical Investigation of Two Tecnis Investigational Lenses
Primary Purpose
Cataract, Corneal Astigmatism
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Investigational IOL Model C1V000
Investigational IOL Model C2V000
Control IOL Model ICB00
Sponsored by
About this trial
This is an interventional other trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Minimum 22 years of age
- Bilateral cataracts or planned natural lens removal (due to immature cataract) for which phacoemulsification extraction and posterior 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
Corneal astigmatism:
- Normal corneal topography
- Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, including posterior corneal astigmatism (PCA)
- Clear intraocular media other than cataract
- Signed informed consent for participation in the study and data protection
- Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
- Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided.
Exclusion Criteria:
- Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D
- Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies (e.g., any observed guttata) 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
- Irregular corneal astigmatism
- Inability to achieve keratometric stability for contact lens wearers
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) 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 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
- 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 outcome 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
Known ocular disease or pathology that, in the opinion of the investigator,
- may affect visual acuity
- may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
- may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
- Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes
- Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
- Desire for monovision correction.
Sites / Locations
- personalEYES Pty. Ltd.
- Vision Eye Institute
- George St Eye Centre
- Bondi Eye Doctors
- Newcastle Eye Hospital
- Sunshine Eye Clinic
- Queensland Eye Institute
- Auckland Eye Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Investigational Lens Device #1
Investigational Lens Device #2
Control Lens
Arm Description
Investigational IOL Model C1V000
Investigational IOL Model C2V000
Control IOL Model ICB00
Outcomes
Primary Outcome Measures
Monocular Photopic distance-corrected intermediate visual acuity
Monocular Photopic best-corrected distance visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT04890249
First Posted
May 6, 2021
Last Updated
March 20, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04890249
Brief Title
Clinical Investigation of Two Tecnis Investigational Lenses
Official Title
Clinical Investigation of the TECNIS® Intraocular Lens, Models C1V000 and C2V000
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL.
The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Corneal Astigmatism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Lens Device #1
Arm Type
Experimental
Arm Description
Investigational IOL Model C1V000
Arm Title
Investigational Lens Device #2
Arm Type
Experimental
Arm Description
Investigational IOL Model C2V000
Arm Title
Control Lens
Arm Type
Active Comparator
Arm Description
Control IOL Model ICB00
Intervention Type
Device
Intervention Name(s)
Investigational IOL Model C1V000
Intervention Description
IOL replaces the natural lens removed during cataract surgery.
Intervention Type
Device
Intervention Name(s)
Investigational IOL Model C2V000
Intervention Description
IOL replaces the natural lens removed during cataract surgery.
Intervention Type
Device
Intervention Name(s)
Control IOL Model ICB00
Intervention Description
IOL replaces the natural lens removed during cataract surgery.
Primary Outcome Measure Information:
Title
Monocular Photopic distance-corrected intermediate visual acuity
Time Frame
6 months
Title
Monocular Photopic best-corrected distance visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum 22 years of age
Bilateral cataracts or planned natural lens removal (due to immature cataract) for which phacoemulsification extraction and posterior 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
Corneal astigmatism:
Normal corneal topography
Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, including posterior corneal astigmatism (PCA)
Clear intraocular media other than cataract
Signed informed consent for participation in the study and data protection
Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided.
Exclusion Criteria:
Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D
Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies (e.g., any observed guttata) 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
Irregular corneal astigmatism
Inability to achieve keratometric stability for contact lens wearers
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) 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 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
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 outcome 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
Known ocular disease or pathology that, in the opinion of the investigator,
may affect visual acuity
may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes
Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
Desire for monovision correction.
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
personalEYES Pty. Ltd.
City
Burwood
State/Province
New South Wales
ZIP/Postal Code
2134
Country
Australia
Facility Name
Vision Eye Institute
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
George St Eye Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Bondi Eye Doctors
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2022
Country
Australia
Facility Name
Newcastle Eye Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Sunshine Eye Clinic
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Queensland Eye Institute
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Auckland Eye Ltd
City
Remuera
State/Province
Auckland
ZIP/Postal Code
1050
Country
New Zealand
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
Learn more about this trial
Clinical Investigation of Two Tecnis Investigational Lenses
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