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Trial registered on ANZCTR


Registration number
ACTRN12618001876280p
Ethics application status
Submitted, not yet approved
Date submitted
9/11/2018
Date registered
19/11/2018
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Handleability and Acceptability Assessment of the DELTA Disposable Delivery System for Participants with Diagnosis of Cataract
Scientific title
Clinical Handleability and Acceptability Assessment of the DELTA Disposable Delivery System for Participants with Diagnosis of Cataract to Measure Acceptable Overall Clinical Performance
Secondary ID [1] 296458 0
IDEV-121-DELT
Universal Trial Number (UTN)
U111-1211-1999
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 310248 0
Condition category
Condition code
Eye 308971 308971 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects who meets the eligibility criteria will be invited to participate in the study. The study doctor will determine which eye(s) will be eligible based on the inclusion/exclusion criteria. Those participants who meet the inclusion/exclusion criteria and agree to participate will be scheduled for surgery to be unilaterally or bilaterally implanted with the TECNIS ZCB00 IOL. Participants will be enrolled at each site sequentially until the recruitment goals are met or the site limit is reached. Inclusion of qualified second eyes in the study, for those being bilaterally implanted, will occur at the investigator’s discretion if within the overall study enrollment period.

Your study doctor will perform the cataract surgery at the surgery center. The investigator should use his or her standard, small-incision (2.2 – 2.4mm) cataract extraction surgical technique. Lenses should be inserted into the capsular bag using the DELTA Disposable Delivery System. Surgery can take 15-20 minutes in duration. The study visits for each eye are outlined below:
Visit 1 – Preoperative Exam to be completed within 45 days prior to surgery
Visit 2 – Operative Visit to be completed the day of the operation
Visit 3 – 1-Day Postoperative Visit to be completed 1-2 days following surgery

For first surgeries, a representative from Sponsor will be present in the operating room for direct observation.
Intervention code [1] 312788 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307942 0
The primary outcome of the study is the Rate of Acceptable Overall Clinical Performance.
The overall clinical performance of the DELTA Disposable Delivery System will be considered acceptable if the combined percentage of Investigator/Surgeon ratings of 3 or higher on a 5-point scale for acceptable clinical performance is at least 95% based on the responses of the Investigator/Surgeon Per-Eye Day-of-Surgery questionnaire, question #6, “How do you rate the overall performance of the DELTA Disposable Delivery System”?
Timepoint [1] 307942 0
Surgeons will provide an assessment after each cataract surgery to assess the overall clinical performance of the device.
Secondary outcome [1] 353406 0
Nil
Timepoint [1] 353406 0
Nil

Eligibility
Key inclusion criteria
• Be at least 22 years old
• Have a cataract in one or both eyes for which IOL implantation is planned
• Sign an informed consent and any additional documentation required by the governing countries
• Be available, able, and willing to comply with the examination procedures of all study visits.
Minimum age
22 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• You are already participating in any other clinical study or have participated in a clinical study during the last 45 days
• You have had recent eye trauma or eye surgery that is not resolved
• You have certain medical conditions, such as poorly-controlled diabetes, which may affect your vision
• You have certain known ocular conditions, such as glaucoma which may affect your vision
• Are unable to have an intraocular lens within the available range for the study
• Are pregnant, planning to become pregnant, are lactating or have another condition associated with the fluctuation of hormones that could lead to changes in your vision.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
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)
NSW,QLD

Funding & Sponsors
Funding source category [1] 301055 0
Commercial sector/Industry
Name [1] 301055 0
Johnson & Johnson Surgical Vision, Inc.
Address [1] 301055 0
1700 East St. Andrew Place
Santa Ana, CA 92705 USA
Country [1] 301055 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] 300661 0
Commercial sector/Industry
Name [1] 300661 0
AMO Australia Pty Limited
Address [1] 300661 0
1-5 Khartourn Road, North Ryde NSW, 2113, Australia
Country [1] 300661 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301809 0
Bellberry Limited
Ethics committee address [1] 301809 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 301809 0
Australia
Date submitted for ethics approval [1] 301809 0
07/11/2018
Approval date [1] 301809 0
Ethics approval number [1] 301809 0

Summary
Brief summary
This research study is being conducted in order to gather information about the overall clinical performance and ease-of-use of the DELTA Disposable Delivery System, an instrument used in cataract surgery to implant the intraocular lens (IOL) into the eye. Delivery systems are commonly used in cataract surgery, this study is simply testing a new type of delivery system. Intraocular lenses are implanted as part of routine cataract surgery to restore vision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88182 0
Dr Brendan Cronin
Address 88182 0
Queensland Eye Institute
140 Melbourne Street, South Brisbane, QLD 4101
Country 88182 0
Australia
Phone 88182 0
+61 7 3239 5000
Fax 88182 0
Email 88182 0
brendan.cronin@qei.org.au
Contact person for public queries
Name 88183 0
Ms Cheryl Harper
Address 88183 0
Johnson & Johnson Surgical Vision, Inc.
1700 E. St. Andrew Place, Santa Ana, CA 92705
Country 88183 0
United States of America
Phone 88183 0
+1 913-396-3276
Fax 88183 0
Email 88183 0
Charper9@its.jnj.com
Contact person for scientific queries
Name 88184 0
Dr Beth Jackson
Address 88184 0
Johnson & Johnson Surgical Vision, Inc.
1700 E. St. Andrew Place, Santa Ana, CA 92705
Country 88184 0
United States of America
Phone 88184 0
+1 817 832-9643
Fax 88184 0
Email 88184 0
BJacks26@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
No plans to share individual participant data.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable