Predicting Risk of Progression of Early to Late AMD in the Aging Eye Through Imaging and Multimodal Evaluation - PRIME Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,500
- Locations
- 2
Study Overview
Brief Summary
The purpose of this research study is to evaluate a new screening procedure for the early detection and monitoring of Age-related Macular Degeneration (AMD) in community settings and community hospital settings, to identify associated risk factors, and develop personalized monitoring strategies for at-risk individuals throughout the 5 years follow up period, which will allow us to establish prevalence, natural history of progression of early AMD in the community.
Detailed Description
An effective screening programme requires several key components to be successful. First, the natural history of the condition needs to be well understood. Next, a clear threshold for referral must be established and finally, effective intervention must be available to treat the condition in question. In ophthalmology, the most effective screening programme we have is for diabetic retinopathy (DR). Here, the natural history and thresholds are well established, and treatment in the form of pan-retinal photocoagulation is effective in preventing progression to visually threatening DR.
While there is consensus regarding features that predispose to late AMD, at an individual level, risk, rate and pattern of progression remain unpredictable therefore there is a need to develop effective AMD screening. This is in contrast to diabetic retinopathy because the natural history is well understood and the risk of vision loss increases sharply in those with referrable DR. In AMD, this threshold is not yet established.
As there is currently no standardized screening protocol for early AMD, especially in the community-based setting and community hospital settings, our study aims to understand the natural progression of AMD in the elderly and establish a referrable threshold before visually threatening AMD occurs. This will ultimately inform a comprehensive and standardized community-based screening approach for AMD.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 55 years or older
- •No severe systemic illnesses that prevent study participation
- •Willing and able to undergo protocol-required procedures for both eyes
- •Willing and able to provide written informed consent
Exclusion Criteria
- •Systemic disorders that preclude reliable clinical examination or multimodal imaging
- •Poor compliance or severe mental illness that hinders participation
- •Persons who are unable to give informed consent
Investigators
Gemmy Cheung Chui Ming
Professor
Singapore National Eye Centre
