Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618002018291p
Ethics application status
Submitted, not yet approved
Date submitted
30/10/2018
Date registered
17/12/2018
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Best pRactIce surGical and refracTive management of cataract: the BRIGhT randomised controlled trial pilot study
Scientific title
Best pRactIce surGical and refracTive management of cataract: the BRIGhT randomised controlled trial pilot study
Secondary ID [1] 296452 0
None
Universal Trial Number (UTN)
U1111-1222-9233
Trial acronym
BRIGhT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 310236 0
Condition category
Condition code
Eye 308961 308961 0 0
Diseases / disorders of the eye
Public Health 308996 308996 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Best Practice Surgical and Refractive (BRIGhT) management strategy for cataract, which combines expedited sequential cataract surgery within 3 months of assessment (consistent with draft Cataract Clinical Care Standard) at either Sydney Eye Hospital or Westmead Hospital and provision of necessary refractive correction through updated spectacle lenses within 2 weeks of second eye surgery. The proposed intervention has been developed based on evidence for the benefits of timely cataract surgery, benefits of operating on both eyes, and the knowledge that post-operative spectacle updates are commonly required. The cataract surgeries will be completed by a hospital staff ophthalmologist and spectacle updates by a community optometrist. Whether any required updates to spectacles has been completed will be known through the record of redemption of the spectacle update voucher. At the follow-up visit where the study participant's spectacles will be measured to confirm the nature of the update to the spectacles. The cataract surgery dates will be extracted from the medical records and reviewed to determine if expedited cataract surgery was successfully delivered in the intervention group and that the control group joined the waiting list and access first eye surgery as expected within 365 days.
Intervention code [1] 312777 0
Treatment: Other
Comparator / control treatment
The control group is the patient receiving standard care with usual waiting time for the second eye cataract surgery. It is likely that patient receive standard care (control group) will only receive first eye surgery during the 12-month enrolment period due to current waiting times at the two public hospital sites.
Control group
Active

Outcomes
Primary outcome [1] 307929 0
Number of falls over 12 months following randomisation, based on prospective, self-reporting by monthly falls calendars
Timepoint [1] 307929 0
Falls will be recorded prospectively for 12 months using monthly calendars with active follow-up
Secondary outcome [1] 353370 0
The EuroQual EQ-5D-5L will be used to assess quality of life and is a standard instrument found to be able to measure the impact of falls, independent of chronic conditions.
Timepoint [1] 353370 0
12 months after randomisation
Secondary outcome [2] 353371 0
The effect on visual disability (using Catquest 9-SF)
Timepoint [2] 353371 0
6 months and 12 months after randomisation
Secondary outcome [3] 353468 0
The effect on physical activities (using Incidental & planned exercise questionnaire)
Timepoint [3] 353468 0
6 months and 12 months after randomisation
Secondary outcome [4] 353469 0
The effect on depression symptoms (geriatric depression scale)
Timepoint [4] 353469 0
6 months and 12 months after randomisation
Secondary outcome [5] 353898 0
A comprehensive economic evaluation incorporating cost-effectiveness and cost-utility analyses will be conducted from a health service provider perspective.
A trial based economic analaysis will be completed using the EuroQual EQ-5D-5L to estimate effectiveness of the intervention.
Data on total health care costs and fall-related health care costs will enable assessment of the within–trial cost-effectiveness of the program.
Timepoint [5] 353898 0
12 months

Eligibility
Key inclusion criteria
Participants with bilateral cataract must be aged 65 years or older, able to walk and living in the community or self-care unit of a retirement village (aged care facility residents will be excluded).
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have a diagnosis of dementia, Parkinson’s Disease or stroke, are wheelchair bound, have significant ocular comorbidities (advanced glaucoma, retinopathy or amblyopia), are scheduled for combined ocular surgery (e.g. cataract and glaucoma), reside outside the metropolitan area, or are otherwise unable to participate in the follow-up assessments.

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)
The randomisation sequence will be generated by an investigator not directly involved in participant recruitment or data entry for falls calendars. This sequence will be uploaded into the on-line database and the randomisation enabled after completion of the baseline assessment. To minimise observational bias, the research assistants conducting the 6- and 12-month assessments will be masked to group allocation. It is not possible to mask the participants to the type of intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be determined using an on-line randomisation process (REDCap).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The number of falls per person-year will be analysed using negative binomial regression to estimate the difference in falls rates between the two groups. The proportion of fallers
and recurrent fallers between groups will be compared using the relative risk statistic. Pre-specified sub-group analyses include previous multiple fallers, degree of vision loss and self-reported and objectively measured physical activity. An intention-to-treat approach will be used for all primary analyses. The relationship between the measures of process and the trial outcomes will be investigated using multivariate negative binomial regression with the count of falls as the outcome measure and interactions will be explored. A statistical analysis plan will be published before database lock. Quantitative analyses will be conducted using SAS and STATA software packages.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12299 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment hospital [2] 12300 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 24493 0
2000 - Sydney
Recruitment postcode(s) [2] 24494 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 301047 0
Government body
Name [1] 301047 0
NSW Agency for Clinical Innovation
Address [1] 301047 0
67 Albert Avenue, Chatswood New South Wales 2057
Country [1] 301047 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Level 3, 50 Bridge Street,
Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 300647 0
None
Name [1] 300647 0
Address [1] 300647 0
Country [1] 300647 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301802 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301802 0
G71, East Wing, Edmund Blackett Building
Prince of Wales Hospital
Cnr Avoca and High Streets, Randwick NSW 2031
Ethics committee country [1] 301802 0
Australia
Date submitted for ethics approval [1] 301802 0
16/11/2018
Approval date [1] 301802 0
Ethics approval number [1] 301802 0

Summary
Brief summary
Falls are the primary cause of injury for older Australians and cataract, a very common age-related eye condition, increases risk of having a fall. In the BRIGhT study we will comprehensively evaluate integrated surgical and refractive management through public hospital eye clinics to restore vision and prevent falls. This important project will inform the development of new pathways to access cataract surgery and investment in services for the many older people waiting for cataract surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88158 0
A/Prof Lisa Keay
Address 88158 0
The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050
Country 88158 0
Australia
Phone 88158 0
+61 2 8052 4335
Fax 88158 0
Email 88158 0
l.keay@unsw.edu.au
Contact person for public queries
Name 88159 0
A/Prof Lisa Keay
Address 88159 0
The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050
Country 88159 0
Australia
Phone 88159 0
+61 2 8052 4335
Fax 88159 0
Email 88159 0
l.keay@unsw.edu.au
Contact person for scientific queries
Name 88160 0
A/Prof Lisa Keay
Address 88160 0
The George Institute for Global Health
PO Box M201, Missenden Road
Camperdown, NSW 2050
Country 88160 0
Australia
Phone 88160 0
+61 2 8052 4335
Fax 88160 0
Email 88160 0
l.keay@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study and will determine feasibility. It is a small dataset and will not be made available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results