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

NCT07060196 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-07-11

No results posted yet for this study

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.

Conditions

  • AMD - Age-Related Macular Degeneration

Interventions

DIAGNOSTIC_TEST

Distant Visual Acuity

Distant Visual acuity of all participants using DDART web-application monocularly in both eyes.

DIAGNOSTIC_TEST

Optical Coherence Tomography

Optical Coherence Tomography of the macula will be performed to all patients.

DIAGNOSTIC_TEST

Optical Coherence Tomography Angiography

Optical Coherence Tomography Angiography of the macula will be performed to all patients.

DIAGNOSTIC_TEST

Autofluorescence imaging

Autofluorescence imaging using fundus camera for AMD staging.

Sponsors & Collaborators

  • Democritus University of Thrace

    lead OTHER

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07060196 on ClinicalTrials.gov