NCT07060196Not yet recruiting
The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration
The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration.
Source: ClinicalTrials.gov · Last updated 11 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 19 Jun 2025
- Start date
- 30 Jun 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Democritus University of Thrace
- Diseases
- Macular degeneration
- NCT number
- NCT07060196
What you commit to
- Study type: Observational
- Planned participants: 70
- From 30 Jun 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone intraocular surgeries, except for uncomplicated cataract extraction surgery performed at least 3 months prior to their inclusion in the study.
Other illness
- 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 neurological, orthopedic, or psychiatric disorders that prevent them from completing the activities or conditions that may affect their performance.
Other
- Patients with binocular best-corrected distance visual acuity less than or equal to hand motion perception.
Who the study is looking for
- Healthy controls over the age of 60.
- Diagnosis of bilateral dry age-related macular degeneration (AMD).
Age in the registry: 60 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Alexandroupolis Coordinator of this site? Confirm its status | Alexandroupoli | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.