Trial Review

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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
Scientific title
Dropless cataract surgery: assessing the safety and efficacy of intracameral antibiotics and subconjunctival steroid bolus injections on post-operative inflammation
Secondary ID [1] 309484 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract surgery 329759 0
Condition category
Condition code
Eye 326657 326657 0 0
Diseases / disorders of the eye
Surgery 330229 330229 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325917 0
Prevention
Intervention code [2] 325918 0
Treatment: Drugs
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.
Control group
Historical

Outcomes
Primary outcome [1] 334526 0
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).
Timepoint [1] 334526 0
Day 1, Day 7, Day 30 and Day 60 (primary endpoint) post-operative,
Secondary outcome [1] 420993 0
The number of patients who require additional topical ‘rescue’ eye drops in the post-operative period as per clinical records
Timepoint [1] 420993 0
Day 1, Day 7, Day 30 and Day 60 post-operative
Secondary outcome [2] 420994 0
The rate of post-operative cystoid macular oedema using optical coherence tomography
Timepoint [2] 420994 0
Day 1, Day 7, Day 30 and Day 60 post-operative
Secondary outcome [3] 420995 0
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.
Timepoint [3] 420995 0
Day 1, Day 7, Day 30 and Day 60 post-operative

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24559 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 40155 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313680 0
Hospital
Name [1] 313680 0
Royal Adelaide Hospital (in-kind)
Country [1] 313680 0
Australia
Primary sponsor type
Individual
Name
Prof WengOnn Chan
Address
N/A
Country
Australia
Secondary sponsor category [1] 315481 0
None
Name [1] 315481 0
Address [1] 315481 0
Country [1] 315481 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312844 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 312844 0
Port Rd, Adelaide SA 5000
Ethics committee country [1] 312844 0
Australia
Date submitted for ethics approval [1] 312844 0
09/02/2024
Approval date [1] 312844 0
Ethics approval number [1] 312844 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126118 0
Dr WengOnn Chan
Address 126118 0
Royal Adelaide Hospital Port Road, Adelaide SA 5000
Country 126118 0
Australia
Phone 126118 0
+61 8 7074 0000
Fax 126118 0
Email 126118 0
wengOnn.chan@sa.gov.au
Contact person for public queries
Name 126119 0
Dr WengOnn Chan
Address 126119 0
Royal Adelaide Hospital Port Road, Adelaide SA 5000
Country 126119 0
Australia
Phone 126119 0
+61 8 7074 0000
Fax 126119 0
Email 126119 0
wengOnn.chan@sa.gov.au
Contact person for scientific queries
Name 126120 0
Dr WengOnn Chan
Address 126120 0
Royal Adelaide Hospital Port Road, Adelaide SA 5000
Country 126120 0
Australia
Phone 126120 0
+61 8 7074 0000
Fax 126120 0
Email 126120 0
wengOnn.chan@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data (after de-identification) underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator
wengOnn.chan@sa.gov.au


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.