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Trial registered on ANZCTR


Registration number
ACTRN12618001773224p
Ethics application status
Submitted, not yet approved
Date submitted
17/10/2018
Date registered
29/10/2018
Date last updated
29/10/2018
Date data sharing statement initially provided
29/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Investigation of the TECNIS® Toric Intraocular Lens for patients who have previously had cataract surgery to determine the amount of postoperative astigmatism compared to preoperative astigmatism
Scientific title
Clinical Investigation of the TECNIS® Toric Intraocular Lens, Model ZCT100 to determine the amount of postoperative astigmatism compared to preoperative astigmatism
Secondary ID [1] 296076 0
Nil known
Universal Trial Number (UTN)
U1111-1220-4309
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Astigmatism 309644 0
Condition category
Condition code
Eye 308447 308447 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Data from the routine examination for the preoperative, operative, one day and one month will be collected retrospectively from the clinical records that are maintained at the study site and surgery center.

In the prospective visit informed consent will be obtained. Routine eye examination including evaluation of the TECNIS ZCT100 and/or TECNIS ZCB00 IOLs, in addition to photographs of the TECNIS Toric intraocular lens Model ZCT100, dilation and measurements to determine the amount of residual astigmatism will be performed.
Intervention code [1] 312414 0
Not applicable
Comparator / control treatment
The comparator intraocular lens (IOL) is the non-toric TECNIS® ZCB00 IOL

Control group
Historical

Outcomes
Primary outcome [1] 307429 0
Primary outcome of the study is to determine the amount of astigmatism that is remaining after implantation of the ZCT100 IOL as measured by the phoropter.
Timepoint [1] 307429 0
Primary timepoint: 3-18 months post implantation.

Enrollment is planning to take approximately 5 months. During that time, participants will be offered a convenient date for the single prospective visit. Participants must be at least 3 months and no more than 18 months postoperative to be eligible for the study.
Secondary outcome [1] 351878 0
Nil
Timepoint [1] 351878 0
Nil

Eligibility
Key inclusion criteria
1. Be at least 22 years of age at the time of screening
2. Be available, willing, and possess sufficient cognitive awareness to comply with procedures set forth in this protocol
3. Read, understand and sign the statement of informed consent and any additional documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing country
4. Have at least one eye for which:
a. Cataract extraction and posterior chamber IOL implantation was performed with or without Laser-Assisted Cataract Surgery at least 3 months (90 days) and no more than 18 months (540 days) prior to enrollment
b. The magnitude of the preoperative corneal astigmatism was between 0.50 and 1.50 diopters (inclusive) as measured by keratometry
c. Either the TECNIS® ZCB00 IOL or TECNIS® ZCT100 IOL was implanted
d. The IOL power was calculated using optical biometry (i.e., not ultrasound biometry or other means)
e. The postoperative best corrected distance monocular visual acuity (as measured at the 1-month postoperative visit) is 20/30 (6/9) Snellen or better
f. The ocular media is clear, with the exception of mild posterior capsular opacification which, in the opinion of the investigator, will not affect study outcomes
g. If Nd:YAG (Neodymium-doped yttrium aluminum garnet) capsulotomy has been performed or is required, the participant must be at least 1-week postoperative prior to prospective data collection.
Minimum age
22 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Amblyopia or strabismus
2. Inability to focus or fixate for prolonged periods of time
3. Acute, chronic, or uncontrolled ocular or systemic disease (including diabetes) or condition which, in the opinion of the investigator, may affect study endpoints or result in increased risk to the participant
4. Current use of systemic or ocular medications that in the opinion of the investigator may affect vision
5. Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that, in the opinion of the investigator, may confound study endpoints or increase the risk to the participant
6. Concurrent or history (within 30 days prior to screening) of participation in any other clinical trial
7. For eligible eye(s) all of the following exclusion criteria apply:
a. Capsular or zonular abnormalities that may have affected postoperative centration or tilt of the IOL
b. Pupil abnormalities (non-reactive, tonic pupils, or abnormally shaped pupils)
c. Medical conditions (e.g., pupil atrophy) or medication that precludes the pupil from achieving at least 6mm diameter upon pharmacological dilation
d. Visually significant Epithelial Basement Membrane Dystrophy on biomicroscopy examination
e. Evidence of keratoconus or significant irregular astigmatism on measurement of corneal topography or keratometry
f. History of significant ocular trauma or ocular surgery (other than cataract extraction and IOL implantation), including refractive surgery (LASIK, LASEK, RK, PRK, limbal relaxing incisions, astigmatic keratotomy, etc.), toric IOL repositioning, or an expectation to undergo surgical intervention and/or ocular laser treatment during the study period (with the exception of Nd:YAG capsulotomy, however this must have been done at least 1 week prior to prospective data collection)
g. History of PMMA (Poly methyl methacrylate) lens wear within 6 months, gas permeable lens wear within 1 month, or extended-wear or daily soft contact lens wear within 7 days prior to the date of cataract surgery or prior to the prospective visit for this study

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 300667 0
Commercial sector/Industry
Name [1] 300667 0
Johnson & Johnson Surgical Vision, Inc.
Address [1] 300667 0
1700 East St. Andrew Place
Santa Ana, CA 92705 USA
Country [1] 300667 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Surgical Vision, Inc.
Address
1700 East St. Andrew Place
Santa Ana, CA 92705 USA
Country
United States of America
Secondary sponsor category [1] 300189 0
None
Name [1] 300189 0
None
Address [1] 300189 0
None
Country [1] 300189 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301449 0
Bellberry Limited
Ethics committee address [1] 301449 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 301449 0
Australia
Date submitted for ethics approval [1] 301449 0
23/10/2018
Approval date [1] 301449 0
Ethics approval number [1] 301449 0

Summary
Brief summary
The purpose of this observational study (no treatment) is to determine the amount of postoperative astigmatism compared to the preoperative astigmatism for participants implanted with TECNIS toric ZCT100 IOL.

For eyes implanted with the TECNIS toric ZCT100, the amount of postoperative astigmatism should be lower than the amount of preoperative astigmatism. For eyes implanted with the TECNIS ZCB00, the amount of postoperative astigmatism may be unchanged compared to the amount of preoperative astigmatism.

This trial will collect preoperative, operative, and postoperative data from the participant’s clinical records for the visits already occurred, and data for the single visit to be collected for the prospective visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87042 0
Dr Daniel Black
Address 87042 0
Sunshine Eye Clinic
Suite 20
2nd Floor
5 Innovation Parkway
Birtinya 4575 Queensland
Country 87042 0
Australia
Phone 87042 0
+61 07 5413 8000
Fax 87042 0
Email 87042 0
info@suneye.com.au
Contact person for public queries
Name 87043 0
Ms Cheryl Harper
Address 87043 0
Johnson & Johnson Surgical Vision, Inc.
1700 E. St. Andrew Place
Santa Ana, CA 92705



Country 87043 0
United States of America
Phone 87043 0
+1 913 396 3276
Fax 87043 0
Email 87043 0
Charper9@its.jnj.com
Contact person for scientific queries
Name 87044 0
Mr Benjamin Straker
Address 87044 0
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA

Country 87044 0
United States of America
Phone 87044 0
+1 904 443 1380
Fax 87044 0
Email 87044 0
bstraker@Its.jnj.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable