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Trial registered on ANZCTR
Registration number
ACTRN12624000521527p
Ethics application status
Submitted, not yet approved
Date submitted
19/04/2023
Date registered
26/04/2024
Date last updated
26/04/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Dropless cataract surgery: assessing the safety of intracameral antibiotics and subconjunctival steroid bolus injections
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Scientific title
Dropless cataract surgery: assessing the safety and efficacy of intracameral antibiotics and subconjunctival steroid bolus injections on post-operative inflammation
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Secondary ID [1]
309484
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Nil known
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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 surgery
329759
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Condition category
Condition code
Eye
326657
326657
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0
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Diseases / disorders of the eye
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Surgery
330229
330229
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Over a 6-month period, the intervention will involve patients undergoing standard phacoemulsification cataract surgery in the operating suites at the Royal Adelaide Hospital, with a subconjunctival triamcinolone acetonide (KENACORT) injection (40mg/mL) administered at the end of the surgical procedure. An intracameral injection of antibiotics (1mg/mL cefazolin) will also be administered immediately afterwards in all cases for endophthalmitis prophylaxis and those with known cefazolin allergies will be treated with intracameral moxifloxacin or vancomycin. These injections will be administered by an ophthalmologist. Following surgery, all patients will have at least a 3-month post-operative follow-up period. Follow-up will be performed on day 1, day 7, day 30 and day 60. Patients receiving routine topical corticosteroid drops will be included as control arm subjects.
Strategies to monitor adherence to the intervention include checking the patient surgical records.
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Intervention code [1]
325917
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Prevention
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Intervention code [2]
325918
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Treatment: Drugs
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Comparator / control treatment
Patients receiving routine topical corticosteroid eyedrops over a 6 month period from January to June 2024 will be included as control arm subjects.
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Control group
Historical
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Outcomes
Primary outcome [1]
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The primary outcome of this study is post-operative inflammation following cataract surgery, which was determined by assessing the degree of inflammation after the dropless cataract surgery. This will be done via the grading of anterior chamber (AC) inflammation (1-4) using slit lamp biomicroscopy and investigations (optical coherence tomography and biometry).
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Assessment method [1]
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Timepoint [1]
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Day 1, Day 7, Day 30 and Day 60 (primary endpoint) post-operative,
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Secondary outcome [1]
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The number of patients who require additional topical ‘rescue’ eye drops in the post-operative period as per clinical records
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Assessment method [1]
420993
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Timepoint [1]
420993
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Day 1, Day 7, Day 30 and Day 60 post-operative
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Secondary outcome [2]
420994
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The rate of post-operative cystoid macular oedema using optical coherence tomography
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Assessment method [2]
420994
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Timepoint [2]
420994
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Day 1, Day 7, Day 30 and Day 60 post-operative
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Secondary outcome [3]
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Tolerability of patients to this approach including the rate of toxic anterior segment syndrome and incidence of steroid-induced elevations in intraocular pressure (assessed using slit-lamp examination and tonometry). This will be assessed as a composite outcome.
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Assessment method [3]
420995
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Timepoint [3]
420995
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Day 1, Day 7, Day 30 and Day 60 post-operative
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Eligibility
Key inclusion criteria
Inclusion criteria for this study includes patients over 18 years’ of age who are scheduled to undergo phacoemulsification cataract surgery in the Ophthalmology outpatient department or inpatient setting at the Royal Adelaide Hospital between a designated to be announced (TBA) 6-month period.
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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
Exclusion criteria for this study includes pregnant patients, patients with prior intraocular surgery, history of steroid-responsive glaucoma, diabetes mellitus and intraoperative complications such as vitreous loss, zonular dialysis and posterior capsular rupture.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Descriptive statistics will be employed to describe the patients’ characteristics at baseline and post-operative clinical data (mean and standard deviation).
Shapiro-Wilk tests will be used to evaluate the normality of the collected data. If the data adheres to a normal distribution, unpaired t tests will be employed. If the data do not adhere to a normal distribution, a Wilcoxon-signed rank test will be utilized. Differences will be considered significant at a p value of <0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2024
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Actual
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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
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
24559
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
40155
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
313680
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Hospital
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Name [1]
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Royal Adelaide Hospital (in-kind)
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Address [1]
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Royal Adelaide HospitalPort Rd, Adelaide SA 5000
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Country [1]
313680
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Australia
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Primary sponsor type
Individual
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Name
Prof WengOnn Chan
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Address
N/A
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Country
Australia
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Secondary sponsor category [1]
315481
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None
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Name [1]
315481
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Address [1]
315481
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Country [1]
315481
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
312844
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
312844
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Port Rd, Adelaide SA 5000
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Ethics committee country [1]
312844
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Australia
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Date submitted for ethics approval [1]
312844
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09/02/2024
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Approval date [1]
312844
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Ethics approval number [1]
312844
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Summary
Brief summary
In this study, we will assess the efficacy and safety of a dropless regimen in adequately controlling post-operative inflammation after cataract surgery. This study is a prospective, single-centre, non-randomized single-arm interventional study aiming to evaluate the tolerability of phacoemulsification without post-operative anti-inflammatory and antibiotics. This study will be conducted at the Royal Adelaide Hospital.
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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
126118
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Dr WengOnn Chan
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Address
126118
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Royal Adelaide Hospital Port Road, Adelaide SA 5000
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Country
126118
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Australia
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Phone
126118
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+61 8 7074 0000
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Fax
126118
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Email
126118
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[email protected]
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Contact person for public queries
Name
126119
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Dr WengOnn Chan
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Address
126119
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Royal Adelaide Hospital Port Road, Adelaide SA 5000
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Country
126119
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Australia
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Phone
126119
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+61 8 7074 0000
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Fax
126119
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Email
126119
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[email protected]
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Contact person for scientific queries
Name
126120
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Dr WengOnn Chan
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Address
126120
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Royal Adelaide Hospital Port Road, Adelaide SA 5000
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Country
126120
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Australia
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Phone
126120
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+61 8 7074 0000
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Fax
126120
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Email
126120
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data (after de-identification) underlying published results only
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
Anyone who wishes to access it
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Available for what types of analyses?
Any purpose
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How or where can data be obtained?
Access subject to approvals by Principal Investigator
[email protected]
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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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