Best pRactIce surGical and refracTive management of cataract: the BRIGhT randomised controlled trial pilot study

Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: 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. CONDITION: Cataract; ; Cataract Eye ‐ Diseases / disorders of the eye Public Health ‐ Health service research PRIMARY OUTCOME: Number of falls over 12 months following randomisation, based on prospective, self‐reporting by monthly falls calendars[Falls will be recorded prospectively for 12 months using monthly calendars with active follow‐up] SECONDARY OUTCOME: 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. ; [12 months] The effect on depression symptoms (geriatric depression scale)[6 months and 12 months after randomisation] The effect on physical activities (using Incidental & planned exercise questionnaire)[6 months and 12 months after randomisation] The effect on visual disability (using Catquest 9‐SF)[6 months and 12 months after randomisation] 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. [12 months after randomisation ] 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).
Epistemonikos ID: bc6e115fd23b3713058d3aa5b06d006f4de63b74
First added on: Aug 24, 2024