NCT05675917

MacuTest Website for Personalized AMD Risk Prediction and Prevention

Feasibility and Acceptability of the MacuTest Website for Personalized AMD Risk Prediction and Prevention: Pilot Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

LEHA team of Bordeaux University has developed an Age-related Macular Degeneration (AMD) prediction algorithm (taking into account age, 49 genetic variants, the presence of early retinal abnormalities, tobacco consumption, food quality, blood pressure and education level) and is currently developing the MacuTest website, integrating this prediction algorithm. This platform offers participants the possibility to enter their personal lifestyle data, to couple them with an ophthalmological examination and a genetic test, in order to evaluate their personalized risk of AMD. The main objective of this pilot study is to evaluate the feasibility of estimating the predicted AMD risk

Detailed description

AMD is the leading cause of blindness in industrialized countries. Current treatments only address the neovascular form and do not always prevent vision loss. This multifactorial pathology involves both genetic factors (more than 50 loci identified) and environmental factors. The genes identified suggest an important contribution of inflammation and innate immunity as well as lipid metabolism in the physiopathology of AMD. As a potential target for preventive actions, the role of lifestyle has also been the subject of much work. Thus, epidemiological studies have identified smoking as an important risk factor. The role of nutrition and metabolism in ocular aging is of growing interest, with hypotheses focusing more specifically on the joint effect of antioxidants and lipids. It is therefore important to develop prevention strategies. In this context, it is necessary to be able to identify at an early stage those people most at risk of developing AMD, in order to propose interventions aimed at reducing the risk of visual loss (reinforced ophthalmological follow-up for rapid detection and treatment of neovascular forms, lifestyle recommendations, nutritional supplementation, etc.). During the baseline (V1) and the 12-months follow-up (V3) visits, lifestyle data (tobacco, diet, education) will be collected within online self-questionnaires on the MacuTest platform. Ophthalmological examination with evaluation of retinal anomalies, blood pressure, and saliva collection (inclusion only) for genetic testing will be perform by the ophthalmologist. At the 6-months follow-up visit (V2), the ophthalmologist will give the participant the results of the genetic test and explanations and interpretation of the results he or she deems necessary. At the 12-months follow-up visit (V3), the participant will fill in a questionnaire to evaluate the MacuTest platform.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DEVICE	MacuTest platform	The MacuTest platform will be used to collect the data needed to predict AMD risk. AMD risk prediction is evaluated by a mathematical algorithm based on the data collected and integrated into the platform. The ophthalmologist will fill in the ophthalmologist questionnaire in the platform with data on the fundus and blood pressure, after examining the patient. The patient will fill in the lifestyle questionnaires (nutrition, smoking, gender, year of birth, level of education) with his personal equipment (computer, smartphone or tablet).

Timeline

• Start date: 2024-02-02
• Primary completion: 2024-02-02
• Completion: 2024-02-02
• First posted: 2023-01-09
• Last updated: 2024-02-12