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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000048482
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
20/01/2025
Date last updated
21/04/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Outcomes of surgery using Zeiss Quatera 700 in adults with complex cataract in Broome, Western Australia.
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Scientific title
Impact of surgery with Post-Market Zeiss Quatera 700 on central endothelial cell count in adults with complex cataract in Broome, Western Australia.
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Secondary ID [1]
313466
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None
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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:
Cataract
335869
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Condition category
Condition code
Eye
332454
332454
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Observational
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Patient registry
False
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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
Complex cataract surgery with Zeiss Quatera 700
Cataract surgery will be performed by an Ophthalmologist at the Broome Regional Hospital with the Zeiss Quatera 700 machine. Patients will have cataract surgery performed with Quatera 700 regardless of their participation in this study. The Zeiss Quatera 700 is an approved cataract surgery machine, therefore Ophthalmologists require no additional training to use it. However, a Zeiss rep was present for the first few surgical lists for each surgeon in April and May 2023 to troubleshoot and help establish surgeon preference parameters.
Under routine care, patients undergoing cataract surgery attend one pre-operative appointment and post-operatively will have a follow-up the next day and a month later. As part of this study, participants will be asked to attend an additional three-month follow-up visit. These clinic visits will be conducted face-to-face by Lions Outback Vision Ophthalmologists or Registered Medical Officers, although the doctor may not be the one that performed the surgery. Further details including procedures undertaken at these visits are outlined below.
Visit 1, 60 minutes at LOV clinic, pre-operative: Visual acuity - aided, unaided, pinhole; intraocular pressure (IOP); biometry; slit lamp examination; fundus examination, specular microscopy.
Surgical visit, up to 30 minutes for surgery and 4-6 hours for hospital visit at Broome Hospital: Cataract surgery performed by an Ophthalmologist at the Broome Regional Hospital with the Zeiss Quatera 700 machine.
Visit 2, 30 minutes at LOV clinic, 1 day post-operative: Uncorrected distance visual acuity (UDVA), IOP, pachymetry.
Visit 3, 45 minutes at LOV clinic, 1 Month post-operative: UDVA, IOP, optical coherence tomography (OCT) macula, pachymetry, specular microscopy.
Visit 4, 45 minutes at LOV clinic, 3 Month post-operative: UDVA, IOP, OCT macula, pachymetry, specular microscopy.
Adherence to the intervention will be assessed through review of the electronic medical record.
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Intervention code [1]
330038
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
339997
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Central endothelial cell count
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Assessment method [1]
339997
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measured with Topcon SP-1P specular microscope
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Timepoint [1]
339997
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pre-operative assessment; one-month post-operation; and three months post-operation
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Secondary outcome [1]
442841
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Uncorrected distance visual acuity (UDVA)
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Assessment method [1]
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ETDRS chart @ 3 m
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Timepoint [1]
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Day 1 and 1-month post-operation
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Secondary outcome [2]
442840
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Presence of complications including anterior chamber collapse during surgery, posterior capsular rent, retained lens fragment, placement of sulcus intraocular lens, endophthalmitis
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Assessment method [2]
442840
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Surgeon to assess during surgery and during clinical examination at each follow up visit and record in medical notes
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Timepoint [2]
442840
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At the end of the surgical procedure, 1-day, 1-month and 3-month post-operation.
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Secondary outcome [3]
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Surgical technique used
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Assessment method [3]
442836
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Recorded by surgeon in medical notes
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Timepoint [3]
442836
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At the end of the surgical procedure
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Secondary outcome [4]
442839
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Volume of Aspirated Fluid
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Assessment method [4]
442839
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Surgeon will take a screenshot of the Quatera screen at the END of the procedure which will show these parameters.
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Timepoint [4]
442839
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At the end of the surgical procedure
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Secondary outcome [5]
442838
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Effective Phaco Time
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Assessment method [5]
442838
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Surgeon will take a screenshot of the Quatera screen at the END of the procedure which will show these parameters.
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Timepoint [5]
442838
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At the end of the surgical procedure
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Secondary outcome [6]
442842
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Corneal thickness
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Assessment method [6]
442842
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IOL Master 700
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Timepoint [6]
442842
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Day 1 and 1-month post-operation
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Secondary outcome [7]
442835
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Phaco energy
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Assessment method [7]
442835
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Surgeon will take a screenshot of the Quatera screen at the START of the procedure which will show this parameter.
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Timepoint [7]
442835
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At the start of the surgical procedure
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Secondary outcome [8]
442837
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Total Phaco Time
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Assessment method [8]
442837
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Surgeon will take a screenshot of the Quatera screen at the END of the procedure which will show these parameters.
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Timepoint [8]
442837
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At the end of the surgical procedure
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Eligibility
Key inclusion criteria
Adults (18 years and over) with complex cataract, defined as meeting any of the following criteria:
a) those with cataract following traumatic ocular injury resulting in zonular dehiscence;
b) those with pseudoexfoliation syndrome;
c) those with dense cataract;
d) those with short anterior chamber depth (less than 2.5mm);
e) those with small pupils (less than 4mm diamter when dilated)
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Minimum age
18
Years
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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. Those with pre-operative central endothelial cell count of less than 1500 cells/mm2
2. Those with prior corneal disease including corneal scars, severe dry eye syndrome
3. Those with prior pupillary abnormalities
4. Those with very guarded visual prognosis, e.g. no perception of light and/or relative afferent pupil defect
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
Clinical characteristics and demographic information will be summarised by mean (standard deviation) or median (interquartile range) depending on the continuous variables’ distribution and frequency (percentage) for categorical variables. Primary and secondary outcome continuous variables with repeated measurements will be assessed with the paired t-test. Other variables will be summarised with descriptive statistics.
As this is an exploratory analysis, sample size calculation was not performed. Participants with missing data will be excluded from analysis.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
28/01/2025
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Date of last participant enrolment
Anticipated
2/02/2026
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Actual
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Date of last data collection
Anticipated
4/05/2026
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Actual
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Sample size
Target
10
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Accrual to date
3
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
317903
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Commercial sector/Industry
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Name [1]
317903
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Carl Zeiss Meditec, Inc.
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Address [1]
317903
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Country [1]
317903
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United States of America
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Primary sponsor type
Individual
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Name
Dr Angus Turner, Lions Eye Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
320246
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None
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Name [1]
320246
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Address [1]
320246
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Country [1]
320246
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316591
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The University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
316591
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http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
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Ethics committee country [1]
316591
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Australia
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Date submitted for ethics approval [1]
316591
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16/09/2024
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Approval date [1]
316591
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27/09/2024
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Ethics approval number [1]
316591
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2024/ET000612
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Summary
Brief summary
Cataracts are easily treated with surgery, but there is a small risk of damaging the endothelial cells of the cornea which can lead to corneal swelling, affecting vision. Certain conditions such as traumatic cataract increase this risk. The Quatera 700 is an innovative machine used for cataract surgery, designed to cause less damage to the corneal endothelium. As such, we aim to document recovery of 10 complex surgery cataract surgery cases performed using this Quatera 700, in particular the change in cell count of the corneal endothelium. Patients who consent to the project will undergo routine care for their complex cataracts, but will attend additional appointments to measure the endothelial cell count (non-invasive imaging), which has minimal to no adverse effects.
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Trial website
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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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Dr Angus Turner
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Address
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Lions Eye Institute, 45 Frederick Street, Broome WA 6725
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Country
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Australia
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Phone
138346
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+61422279179
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Fax
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Email
138346
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[email protected]
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Contact person for public queries
Name
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Emma Doulgas
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Address
138347
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Lions Eye Institute, 45 Frederick Street, Broome WA 6725
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Country
138347
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Australia
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Phone
138347
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+61 63820532
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Fax
138347
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Email
138347
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[email protected]
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Contact person for scientific queries
Name
138348
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Angus Turner
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Address
138348
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Lions Eye Institute, 45 Frederick Street, Broome WA 6725
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Country
138348
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Australia
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Phone
138348
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+61422279179
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Fax
138348
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Email
138348
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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