NCT05913063

Brief Summary

Age-related macular degeneration (AMD), is a debilitating eye disease that causes a loss of central vision. The prevalence of AMD increases exponentially with age and causes a significant impact through both medical expenses and the social and economic costs associated with vision loss. AMD is the global leading cause of blindness among people over the age of 60. Detection of this eye disease at early stages coupled with prompt treatment can prevent vision loss; however, modern diagnosis methods are ineffective at diagnosis of AMD before vision loss occurs. While a range of available treatment options has been effective at slowing vision loss due to AMD, no treatment exists which can recover lost vision. The investigators propose to apply tools developed in quantum information science to diagnose AMD before vision has been affected, drastically improving health outcomes for patients with AMD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
41mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress46%
Jun 2023Oct 2029

First Submitted

Initial submission to the registry

May 31, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

May 31, 2023

Last Update Submit

March 16, 2026

Conditions

Keywords

Age-Related Macular DegenerationStructured LightOrbital Angular MomentumPolarization PerceptionRetinal Imaging

Outcome Measures

Primary Outcomes (2)

  • Perception of the structured light

    Assessment of the participant's ability to see the entoptic phenomena created using the structured light (SL) - orbital angular momentum (OAM) coupled polarized light. Various SL vortex and radial patterns will be projected using the custom research-based laser optical setup

    Approximately 10 minutes, Screening and Training day (Session 1)

  • Radius of the radial retinal polarizer

    Calculation of the radius of the central obstruction. From a total of 14 reversal trials, the six last values of the mask size will be used for the calculation of the threshold mask size mean (r mean). The standard deviation will be computed from the variance of these last six trials

    Approximately 30 minutes, on the completion of the study (Session 6)

Secondary Outcomes (5)

  • Thickness of retina and retinal layers

    Approximately 10 minutes, Screening and Training day (Session 1)

  • Contrast sensitivity

    Approximately 5 minutes, Screening and Training day (Session 1)

  • Fundus photography

    Approximately 5 minutes, Screening and Training day (Session 1)

  • Ocular biometry measurement

    Approximately 5 minutes, Screening and Training day (Session 1)

  • Macular pigment optical density measurement

    Approximately 10 minutes, Screening and Training day (Sessions 1 and 2)

Study Arms (1)

Participants with Age-Related Macular Degeneration

EXPERIMENTAL

Conducting the psychophysical task on the perception of OAM-coupled polarized light

Device: Structured Light Imaging Microscopy

Interventions

Conducting the psychophysical task on the perception of OAM-coupled polarized light created using the experimental setup - Structured Light Imaging Microscopy (SLIM). Four types of vortex orbital angular momentum, differing by the number of fringes l=5;10; 15;20, will be presented for 0.5s per trial during which an azimuthally varying entoptic profile rotated clockwise or counterclockwise. A circular mask with a varying radius will be placed at fixation, thus the task will be performed at varying eccentricities. Circular obstruction of the area will be achieved due to the high refresh-rate structured light modulator. The threshold mask size will be changed by a 2up/1down staircase method (71% accuracy for the estimation of mask size).

Participants with Age-Related Macular Degeneration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who are clinically diagnosed with a vision disease affecting their macula
  • Older adults who are matched for age.
  • Participants who are clinically diagnosed with glaucoma
  • Participants who have normal vision.
  • One aged-matched control with normal vision will be recruited for each of the diagnosed groups (born in the same year).

You may not qualify if:

  • Participants with any additional eye diagnosis or condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Eye and Vision Research Limited

Hong Kong, Guangdong, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Benjamin Thompson, PhD

    Centre for Eye and Vision Research

    PRINCIPAL INVESTIGATOR
  • Mukhit Kulmaganbetov, MD, PhD

    Centre for Eye and Vision Research

    STUDY DIRECTOR

Central Study Contacts

Benjamin Thompson, PhD

CONTACT

Mukhit Kulmaganbetov, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Within-subject, measuring the threshold SL-based entoptic phenomenon circular obstruction size of the radial retinal polarizer
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 22, 2023

Study Start

June 26, 2023

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Anonymized data will be shared on request

Shared Documents
STUDY PROTOCOL
Time Frame
After the publication of study results for an indefinite period.
Access Criteria
Upon reasonable request and approved by the study principal investigator.

Locations