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Trial registered on ANZCTR


Registration number
ACTRN12624000425594
Ethics application status
Approved
Date submitted
7/03/2024
Date registered
8/04/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
8/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized comparative study of the Active Sentry handpiece versus the Ozil handpiece in phacoemulsification
Scientific title
A randomized comparative study of corneal endothelial cell count in patients undergoing routine bilateral cataract surgery for age-related cataract using the Active Sentry handpiece versus the Ozil handpiece in phacoemulsification
Secondary ID [1] 311674 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 333162 0
Corneal endothelial cell loss 333163 0
Condition category
Condition code
Surgery 329856 329856 0 0
Other surgery
Eye 330106 330106 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A post market trial of two different handpieces used during cataract surgery.
Modern cataract surgery is a highly safe, efficient operation. Despite this, risks of cataract surgery are still apparent including risks to the corneal endothelium which is the highly specialised non -renewable tissue on the inner aspect of the cornea. A critical level of corneal endothelial cells and quality is required to maintain corneal transparency. Cataract surgery does degrade the number and morphology of corneal endothelial cells and there is still a low risk of causing corneal decompensation in certain patients.

The Active Sentry handpiece has an inbuilt fluids pressor sensor which stabilises the anterior chamber during cataract surgery leading to less pressure fluctuations. The Ozil handpiece doesn't have this feature.
The handpiece is used during the phacoemulsification part of cataract surgery, typically around minutes of the 15 minute procedure on average. It will be used by an Ophthalmic surgeon. Phacomeulsification uses Ultrasound energy to emulsify the cataract into pieces that get aspirated up some tubing. Once this is done, an artificial lens implant is inserted into the eye.
The phacoemulsification machine records the ultrasound time, aspiration time, cumulative dispersed energy during the operation and this data will be transferred to a spreadsheet.
Intervention code [1] 328161 0
Treatment: Surgery
Comparator / control treatment
The control group are the eyes which undergo cataract surgery with the Ozil handpiece.

The Ozil handpiece doesn't have the feature of an in built pressure sensor.
The handpiece is used during the phacoemulsification part of cataract surgery, typically around minutes of the 15 minute procedure on average. It will be used by an Ophthalmic surgeon.
The phacoemulsification machine records the ultrasound time, aspiration time, cumulative dispersed energy during the operation and this data will be transferred to a spreadsheet.
Control group
Active

Outcomes
Primary outcome [1] 337632 0
Central endothelial cell count at 3 months post-operatively compared to the baseline pre-operative level in both the Ozil and Active Sentry groups.
Timepoint [1] 337632 0
Baseline and 3 months postoperatively
Secondary outcome [1] 432584 0
Central corneal thickness at the 1 day, 1-week, 4-week and 3-month post-operative check
Timepoint [1] 432584 0
1 day, 1-week, 4-week and 3-month post-operatively
Secondary outcome [2] 433209 0
Aspiration time
Timepoint [2] 433209 0
Intraoperatively
Secondary outcome [3] 433210 0
Ultrasound time
Timepoint [3] 433210 0
Intraoperatively

Eligibility
Key inclusion criteria
Patients aged 50-85 years undergoing routine bilateral cataract surgery for age related cataract
Patients' cataracts graded according to the Lens Opacities Classification System (LOCS) grading system, limited to NS2+ and NS3+
Any Intraocular lens (IOL) placed within the capsular bag
No associated procedures at the time of cataract surgery
Ability to consent to treatment
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fuchs endothelial dystrophy
Cornea guttata
Complicated cataract surgery
Patients diagnosed with Glaucoma or on treatment with Glaucoma drops
Associated procedures such as intra-operative pupil dilation
Shallow Anterior chambers (<2.5mm)
Brunescent or White cataracts
Previous intraocular surgery


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed to the operating surgeon
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin tossing for the first eye into either the Active Sentry group or the Ozil group. The second eye will be the alternative handpiece to the first operation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
29/07/2024
Date of last participant enrolment
Anticipated
14/04/2025
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
84
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 316001 0
Commercial sector/Industry
Name [1] 316001 0
Alcon Australia
Country [1] 316001 0
Australia
Primary sponsor type
Other
Name
RSSM Medical trading as Derwent Eye Specialists
Address
Country
Australia
Secondary sponsor category [1] 318150 0
None
Name [1] 318150 0
Address [1] 318150 0
Country [1] 318150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314827 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 314827 0
Ethics committee country [1] 314827 0
Australia
Date submitted for ethics approval [1] 314827 0
07/03/2024
Approval date [1] 314827 0
17/04/2024
Ethics approval number [1] 314827 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132850 0
Dr Simran Mangat
Address 132850 0
Derwent Eye Specialists, 99 Bathurst Street, Hobart, Tasmania, 7000
Country 132850 0
Australia
Phone 132850 0
+61 421160076
Fax 132850 0
Email 132850 0
simran.mangat@derwenteye.com.au
Contact person for public queries
Name 132851 0
Simran Mangat
Address 132851 0
Derwent Eye Specialists, 99 Bathurst Street, Hobart, Tasmania, 7000
Country 132851 0
Australia
Phone 132851 0
+61 421160076
Fax 132851 0
Email 132851 0
simran.mangat@derwenteye.com.au
Contact person for scientific queries
Name 132852 0
Simran Mangat
Address 132852 0
Derwent Eye Specialists, 99 Bathurst Street, Hobart, Tasmania, 7000
Country 132852 0
Australia
Phone 132852 0
+61 421160076
Fax 132852 0
Email 132852 0
simran.mangat@derwenteye.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive commercial data


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.