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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/NCT05461586
Registration number
NCT05461586
Ethics application status
Date submitted
7/07/2022
Date registered
18/07/2022
Date last updated
6/01/2023
Titles & IDs
Public title
Clinical Investigation of Refraction Techniques
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Scientific title
Clinical Investigation of Refraction Techniques
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Secondary ID [1]
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MDEV104MREE
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Refractive Error
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Refractive Technique (MR #1)
Treatment: Devices - Refractive Technique (MR #2)
MR #1/MR #2 - Subjects who participated in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL lenses will be randomized into the (MR #1/MR #2) sequence and receive two different maximum refractive techniques one at a time consecutively.
MR#2/MR#1 - Subjects who participated in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL lenses will be randomized into the (MR#2/MR#1) sequence and receive two different maximum refractive techniques one at a time consecutively.
Treatment: Devices: Refractive Technique (MR #1)
Fogging method that employs fogging lens to ensure there is sufficient visual defocus to induce blur.
Treatment: Devices: Refractive Technique (MR #2)
Duochrome method that employs the chromatic aberration of the eye, with the shorter wavelengths (green) focused in front of the longer (red) wavelengths
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference between two manifest refractive techniques on outcome variable MRSE
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Assessment method [1]
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Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA).
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Timepoint [1]
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Day 0
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Primary outcome [2]
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Difference between two manifest refractive techniques on visual acuity
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Assessment method [2]
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Refractive technique 1 will use a plus lens fogging technique and refractive technique 2 will use the Duochrome technique to achieve maximum plus refraction for best-corrected visual acuity (BCDVA).
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Timepoint [2]
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Day 0
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Eligibility
Key inclusion criteria
1. Participant in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL, Models
C1V000, C2V000 or ICB00 and have completed and are at least 30 days postoperative from
their second eye surgery;
2. At least one implanted eye with clear ocular media;
3. Signed informed consent and HIPAA authorization or equivalent documentation necessary
to comply with applicable privacy laws pertaining to medical treatment in Australia
and New Zealand;
4. Availability, willingness and sufficient cognitive awareness to comply with
examination procedures.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Best-corrected distance visual acuity (BCDVA) worse than 0.66 decimal (6/9 or 20/30
Snellen);
2. Subjects with ongoing adverse events that might impact outcomes during the study visit
as determined by the investigator.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2022
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Sunshine Eye Clinic - Birtinya
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Recruitment postcode(s) [1]
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4575 - Birtinya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Johnson & Johnson Surgical Vision, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Prospective, multi-center, non-interventional, randomized, comparative clinical study to
identify an optimal refractive technique that provides maximum plus refractive endpoint for
best corrected distance visual acuity (BCDVA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05461586
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Johnson & Johnson Surgical Vision, Inc. Clinical Trial
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Address
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Johnson & Johnson Surgical Vision, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05461586
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