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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04156737




Registration number
NCT04156737
Ethics application status
Date submitted
6/11/2019
Date registered
7/11/2019

Titles & IDs
Public title
A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL
Scientific title
A Comparative Clinical Evaluation of a New TECNIS® Presbyopia-correcting Intraocular Lens Against a Trifocal Intraocular Lens
Secondary ID [1] 0 0
SUR-IOL-652-3002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 0 0
Refractive Error 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 - TECNIS Symfony plus IOL Model ZHR00V
Treatment: Devices - Trifocal Intraocular lens

Experimental: Investigational Lens - TECNIS Symfony plus IOL Model ZHR00V

Active comparator: Control Lens - Trifocal Intraocular Lens


Treatment: Devices: TECNIS Symfony plus IOL Model ZHR00V
IOL replaces the natural lens removed during cataract surgery

Treatment: Devices: Trifocal Intraocular lens
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
Binocular distance-corrected VA of 20/25
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Binocular uncorrected VA of 20/32
Timepoint [2] 0 0
3 months

Eligibility
Key inclusion criteria
(all criteria apply to both eyes):

* Age 22 and older
* Bilateral cataracts or clear crystalline lenses for which posterior chamber IOL implantation has been planned
* Potential postoperative best corrected distance visual acuity (BCDVA) of 0.66 decimal (20/30 or 6/9 Snellen) or better
* Predicted postoperative corneal astigmatism less than 1.0 D, including posterior corneal astigmatism (PCA)
* Clear intraocular media other than cataract in each eye
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
* Written informed consent for participation in the study and data protection.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* (including device labeling, all criteria apply to both eyes):

* Require an intraocular lens power outside the available range of +14.0 to +26.0 D
* Irregular corneal astigmatism (as evaluated by topography)
* 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 loss to a level worse than 0.66 decimal (20/30 or 6/9 Snellen) during the study
* 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
* Pupil abnormalities that 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 loss to a level worse than 0.66 decimal (20/30 or 6/9 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, in the opinion of the investigator, may affect vision
* Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin 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 or hypertension that, in the opinion of the investigator, may mpact visual outcome or increase the risk to the subject
* 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(s) 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 (e.g., ocular surface conditions)
* may require surgical intervention during 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 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 the preoperative visit in any other clinical trial
* Desire for monovision correction

Study design
Purpose of the study
Treatment
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
NA
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
24/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/07/2021
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Philippines
State/province [2] 0 0
Makati
Country [3] 0 0
Spain
State/province [3] 0 0
Cordoba
Country [4] 0 0
Spain
State/province [4] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://yoda.yale.edu/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04156737