The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration
ADLs AMD
1 other identifier
observational
70
1 country
1
Brief Summary
Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in the elderly worldwide. The dry, non-exudative form of the disease, although more common, is associated with gradual and significant decline in functional vision. Despite advancements in diagnostic and therapeutic approaches, a targeted intervention that improves the daily functionality of these patients is still lacking. One critical, yet often overlooked, factor that affects daily performance is lighting conditions. This study aims to objectively assess the impact of different lighting intensity levels on patients with advanced dry AMD during the execution of everyday activities. A total of 60 individuals will be evaluated (30 healthy controls over 60 years of age and 30 patients with clinically diagnosed advanced AMD, according to NICE and AREDS criteria). Participants will undergo ophthalmological assessment (visual acuity, contrast sensitivity, OCT/OCTA, autofluorescence), and their performance on five functional tasks (mobility, object grasping, sit-to-stand transition, obstacle avoidance, and hanging clothes) will be evaluated under eight lighting levels (20-300 lux) at a constant color temperature (4000K), in a specially designed laboratory equipped with motion and eye-tracking systems. The primary endpoint is overall performance, based on task completion time and errors, expressed on a custom performance scale (0-100). Secondary data include changes in pupil size as an indicator of visual adaptation. The study aims to determine the optimal lighting range that maximizes functional vision and improves the quality of life for patients with AMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
July 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
July 11, 2025
July 1, 2025
1.5 years
June 19, 2025
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ADL score
Each participant's activity score will be calculated based on task completion time and errors. Errors will incur time penalties. A total completion time will be derived for each activity under each lighting condition. A custom scoring scale from 0 (lowest) to 100 (highest) will be developed. Each participant's performance score will be generated from this scale, determining the optimal lighting condition for AMD patients.
On the same day as clinical evaluation, approximately 2-4 hours following baseline assessments.
Secondary Outcomes (1)
Pupil Size
On the same day as clinical evaluation, approximately 2-4 hours following baseline assessments.
Study Arms (2)
Control Group
Healthy controls
AMD Patients
Patients with AMD stage 9 in both eyes.
Interventions
Distant Visual acuity of all participants using DDART web-application monocularly in both eyes.
Optical Coherence Tomography of the macula will be performed to all patients.
Optical Coherence Tomography Angiography of the macula will be performed to all patients.
Autofluorescence imaging using fundus camera for AMD staging.
Eligibility Criteria
* Healthy controls over the age of 60 * Patients with bilateral diagnosed advanced AMD (according to the UK's National Institute for Health and Care Excellence-NICE-or AREDS 9-step classification \[13\]), fulfilling at least one of the following criteria: i) Geographic atrophy of the macula ii) Best-corrected visual acuity in the affected eye \<6/18 or logMAR \>0.4 with dense/confluent drusen, advanced RPE changes, or vitelliform lesions iii) Fibrous scar iv) RPE tear v) Atrophy (absence/thinning of RPE and/or retina) vi) Cystoid degeneration (persistent intraretinal fluid or tubular structures unresponsive to therapy)
You may qualify if:
- Healthy controls over the age of 60.
- Diagnosis of bilateral dry age-related macular degeneration (AMD).
You may not qualify if:
- Patients with other ocular conditions such as high myopia, glaucoma, clinically significant diabetic retinopathy, and other diseases that may confound the evaluation of ocular outcome measurements.
- Individuals with systemic diseases, including oxalate kidney stones, Wilson's disease, hemochromatosis, lung cancer, or other illnesses associated with poor five-year survival.
- Patients with binocular best-corrected distance visual acuity less than or equal to hand motion perception.
- Patients with neurological, orthopedic, or psychiatric disorders that prevent them from completing the activities or conditions that may affect their performance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Ophthalmology
Study Record Dates
First Submitted
June 19, 2025
First Posted
July 11, 2025
Study Start
June 30, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
July 11, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share