None listed
Conditions
Brief summary
This aim of the study is to investigates whether a more frequent screening in people at high genetic risk leads to better outcomes in terms of less progression to glaucoma (or to glaucoma suspect), reduced visual fields deterioration, and decreased optic nerve damage (i.e. thicker retina and smaller vertical cup to disc ratio). Who is it for? You may be eligible for this study if you are a male or female, aged 50-70, have reported a first-degree relative with glaucoma (parent, sibling, or child) and self-reported no diagnosis of glaucoma. Study details Participants will be recruited from will be recruited from the P3423 The Genetics of Glaucoma – Family History sub-study cohort based on their risk of glaucoma. Participants in the high predicted risk group will be randomised to either intervention or control group. Participants in the low predicted risk group will be only enrolled in the intervention arm. Our control group will follow standard of care of eye examinations every 2 years during the study duration of 4 years. Our intervention group will be asked to complete 6 monthly eye examination visits for the study duration of 4 years.
Interventions
Eye examinations at baseline and every 6 months for the study duration of 4 years. The aim of this study investigates whether more frequent screening in people at high genetic risk leads to better outcomes in terms of less progression to glaucoma (or to glaucoma suspect), reduced visual fields deterioration, and decreased optic nerve damage. The study intervention arm will be asked to complete 6 monthly eye examinations for the study duration of 4 years. Participants in the high predicted risk g
Eye examinations at baseline and every 6 months for the study duration of 4 years. The aim of this study investigates whether more frequent screening in people at high genetic risk leads to better outcomes in terms of less progression to glaucoma (or to glaucoma suspect), reduced visual fields deterioration, and decreased optic nerve damage. The study intervention arm will be asked to complete 6 monthly eye examinations for the study duration of 4 years. Participants in the high predicted risk group will be randomised to either intervention or control group. Participants in the low predicted risk group will be only enrolled in the intervention arm. In addition to the objectives in the above, we will also conduct a comparison of the top 25% control group versus the low-risk (bottom 25%) group. The goal of this is to allow us to test if the risk prediction algorithm (based on genetics, see below) can successfully predict the development of glaucoma in a high-risk group who receive standard care (2 yearly screening).
Sponsors
QIMR Berghofer
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
P3423 has not be registered with ANZCTR or another trial registry. Participants will be recruited from the P3423 The Genetics of Glaucoma – Family History sub-study cohort. Recruits for this trial are required to meet the following criteria: 1. Participants must be able to give informed consent 2. Participants must be aged 50-70 years old at consent 3. Participants must have a first degree relative with glaucoma (parent, sibling, child) 4. Participants must have self-reported no diagnosis of glaucoma 5. Participants must have had no prior glaucoma treatment (laser, eye drops, other surgery) 6. Participants must note have had taken steroids for a period over 2 weeks in the last year.
Exclusion criteria
- Patients with intellectual or mental impairment who are unable to provide informed consent. - People outside of required age range, i.e. not between age 50-70 years. - Currently on any glaucoma treatment medication.
Outcome results
None listed