The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-100
SponsorDemocritus University of Thrace

About this trial

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.

Eligibility criteria

Qualifiers

Healthy controls over the age of 60.

Diagnosis of bilateral dry age-related macular degeneration (AMD).

Disqualifiers

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.

Patients who have undergone intraocular surgeries, except for uncomplicated cataract extraction surgery performed at least 3 months prior to their inclusion in the study.

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.

Trial design

Treatments tested in this trial

  • Distant Visual Acuity
  • Optical Coherence Tomography
  • Optical Coherence Tomography Angiography
  • Autofluorescence imaging

Treatment groups

70 Participants
are divided into 2 treatment groups