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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04890249




Registration number
NCT04890249
Ethics application status
Date submitted
6/05/2021
Date registered
18/05/2021
Date last updated
22/03/2023

Titles & IDs
Public title
Clinical Investigation of Two Tecnis Investigational Lenses
Scientific title
Clinical Investigation of the TECNIS® Intraocular Lens, Models C1V000 and C2V000
Secondary ID [1] 0 0
PCOL-102-AHSF
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 0 0
Corneal Astigmatism 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Investigational IOL Model C1V000
Treatment: Devices - Investigational IOL Model C2V000
Treatment: Devices - Control IOL Model ICB00

Experimental: Investigational Lens Device #1 - Investigational IOL Model C1V000

Experimental: Investigational Lens Device #2 - Investigational IOL Model C2V000

Active Comparator: Control Lens - Control IOL Model ICB00


Treatment: Devices: Investigational IOL Model C1V000
IOL replaces the natural lens removed during cataract surgery.

Treatment: Devices: Investigational IOL Model C2V000
IOL replaces the natural lens removed during cataract surgery.

Treatment: Devices: Control IOL Model ICB00
IOL replaces the natural lens removed during cataract surgery.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Monocular Photopic distance-corrected intermediate visual acuity
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Monocular Photopic best-corrected distance visual acuity
Timepoint [2] 0 0
6 months

Eligibility
Key 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.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2023
Sample size
Target
Accrual to date
Final
221
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
personalEYES Pty. Ltd. - Burwood
Recruitment hospital [2] 0 0
Vision Eye Institute - Chatswood
Recruitment hospital [3] 0 0
George St Eye Centre - Sydney
Recruitment hospital [4] 0 0
Bondi Eye Doctors - Sydney
Recruitment hospital [5] 0 0
Newcastle Eye Hospital - Waratah
Recruitment hospital [6] 0 0
Sunshine Eye Clinic - Birtinya
Recruitment hospital [7] 0 0
Queensland Eye Institute - South Brisbane
Recruitment postcode(s) [1] 0 0
2134 - Burwood
Recruitment postcode(s) [2] 0 0
2067 - Chatswood
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
2022 - Sydney
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
4575 - Birtinya
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Surgical Vision, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04890249
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Surgical Vision Clinical Trials
Address 0 0
Johnson & Johnson Surgical Vision
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04890249