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Polygenic Risk-Enhanced Detection and Initiation of Glaucoma Treatment: Feasibility Study

Feasibility Assessment for Streamlined Testing in the Polygenic Risk-Enhanced Detection and Initiation of glauComa Treatment trial (FAST-PREDICT) for adult glaucoma suspect referrals

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000543381
Acronym
FAST-PREDICT
Enrollment
13
Registered
2026-04-30
Start date
2026-07-15
Completion date
2026-07-31
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study addresses the lack of a uniform triage framework for glaucoma suspects, which currently varies depending on individual clinician judgement and referral quality. We will trial an RGEC inclusive of a clinical–genetic risk calculator to provide evidence-based, data-driven triage. This approach makes best use of current scientific advances in polygenic risk, translating them into practical tools for glaucoma care. There is an established global precedent in rapid and virtual assessment workflows, but these have not yet been implemented locally, creating an opportunity for RGEC to lead innovation in service delivery in South Australia. RGEC has the potential to improve patient access, reduce unnecessary hospital visits for low-risk individuals, prioritise timely care for high-risk patients, and increase efficiency in overburdened outpatient clinics. In doing so, the study contributes both to the scientific evidence base and to immediate improvements in clinical practice.

Interventions

RAPID GLAUCOMA EVALUATION CLINIC Eligible participants will be invited to a Rapid Glaucoma Evaluation Clinic (RGEC) where they will: 1. Undergo diagnostic examinations (Visual Acuity, Automated Refraction, automated perimetry, intraocular pressure (IOP) and corneal thickness measurement, optical coherence tomography of the anterior segment, macula and optic nerve head, and colour fundus photography) 2. Provide a saliva swab for a NATA-accredited glaucoma polygenic risk score (SightScore) RISK

RAPID GLAUCOMA EVALUATION CLINIC Eligible participants will be invited to a Rapid Glaucoma Evaluation Clinic (RGEC) where they will: 1. Undergo diagnostic examinations (Visual Acuity, Automated Refraction, automated perimetry, intraocular pressure (IOP) and corneal thickness measurement, optical coherence tomography of the anterior segment, macula and optic nerve head, and colour fundus photography) 2. Provide a saliva swab for a NATA-accredited glaucoma polygenic risk score (SightScore) RISK STRATIFICATION PHASE The collected diagnostic information will be inputted into a combined clinical-polygenic risk calculator which will provide a 5 year percentage risk estimate of treatment initiation. The participants will be informed of their risk stratification within 4 to 6 weeks of clinic attendance and instructed on the designated follow-up pathway: - High Risk: allocated to a glaucoma subspecialty clinic waitlist - Intermediate/Medium Risk: reviewed every 6 months in a dedicated glaucoma monitoring clinic - Low Risk: reviewed every 12 months in a dedicated glaucoma monitoring clinic FOLLOW UP PHASE Once the stratification and allocation to care pathway has been completed, clinical care of participants is at the discretion of the clinician. However, all participants will remain enrolled for 24 months from time of enrolment, and their notes from each subsequent clinical visit reviewed for evidence of conversion to glaucoma, defined as the development of a reproducible glaucomatous visual field defect, reproducible IOP > 28 mmHg or reduction in circumpapillary retinal nerve fibre layer (RNFL) thickness of >10% from baseline in either superior or inferior quadrant.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Males and females aged 18 years and over - Category 2 (appointment within 90 days) or Category 3 (within 365 days) glaucoma referrals - Able to understand and complete informed consent to enrol in study - Referred by an optometrist for purpose of glaucoma assessment - Glaucoma treatment naive i.e no previous or current IOP lowering medication, selective laser trabeculoplasty or surgery in either eye

Exclusion criteria

- Category 1 (appointment within 30 days) glaucoma referrals - Best corrected visual acuity < 6/18 - Comorbid active ocular conditions, excluding cataracts and non-neovascular macular degeneration - Diagnosed glaucoma and/or current or prior treatment (including use of long-term IOP lowering medication, selective laser trabeculoplasty, or glaucoma surgery) - Significant cognitive impairment or inability to perform reliable perimetry and obtain informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026