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Direct Discrimination of Quantum States by the Human Eye

Primary Purpose

Age-Related Macular Degeneration

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Structured Light Imaging Microscopy
Sponsored by
Centre for Eye and Vision Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age-Related Macular Degeneration focused on measuring Age-Related Macular Degeneration, Structured Light, Orbital Angular Momentum, Polarization Perception, Retinal Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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). Exclusion Criteria: Participants with any additional eye diagnosis or condition

Sites / Locations

  • Centre for Eye and Vision Research LimitedRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Age-Related Macular Degeneration

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Thickness of retina and retinal layers
Measurement of the retinal layers' thickness and total neuroretina
Contrast sensitivity
Computer-based measurement of contrast sensitivity
Fundus photography
Imaging the retina using white light. The diameter of the optic nerve head will be measured in order to calculate the degree/pixel ratio for each participant
Ocular biometry measurement
Measurement of the central corneal thickness and axial eye length
Macular pigment optical density measurement
Computer-based measurement of the macular pigment optical density (MPOD)

Full Information

First Posted
May 31, 2023
Last Updated
June 26, 2023
Sponsor
Centre for Eye and Vision Research
Collaborators
University of Waterloo, The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05913063
Brief Title
Direct Discrimination of Quantum States by the Human Eye
Official Title
Direct Discrimination of Quantum States by the Human Eye With Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Eye and Vision Research
Collaborators
University of Waterloo, The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
There has been tremendous progress in generating and detecting structured light which possesses advantageous propagation characteristics such as quantized orbital angular momentum (OAM), non-diffraction, and self-healing. These special beams have found applications in microscopy, encoding and multiplexing of communications, and manipulation of matter. Here the investigators bring the structured light toolbox to vision sciences for the first time and expand the space of possible stimuli. A healthy macula possesses azimuthally ordered dichroic fibres that act as a radial polarization filter, enabling a typical person to perceive linearly polarized light through the entoptic phenomena known as Haidinger's brushes. Despite significant interest in the application of this phenomenon to the detection of age-related macular degeneration, no device has currently seen widespread adoption in a clinical environment. This is due to the difficulty in observing Haidinger's brush, the imprecise measurements that this test can extract, and the difficulty in instructing patients during these tests. Leveraging the quantum-inspired toolbox developed in the field of structured light, the investigators can project polarization-coupled OAM states of light directly on a person's retina. This enables the investigators to create arbitrary entoptic patterns in a person's vision based on the structure and chemical composition of their subjective macula, and the investigators have the opportunity to develop a litany of novel diagnostic tests to characterize and quantify the health of the macula.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Age-Related Macular Degeneration, Structured Light, Orbital Angular Momentum, Polarization Perception, Retinal Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Within-subject, measuring the threshold SL-based entoptic phenomenon circular obstruction size of the radial retinal polarizer
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Age-Related Macular Degeneration
Arm Type
Experimental
Arm Description
Conducting the psychophysical task on the perception of OAM-coupled polarized light
Intervention Type
Device
Intervention Name(s)
Structured Light Imaging Microscopy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Perception of the structured light
Description
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
Time Frame
Approximately 10 minutes, Screening and Training day (Session 1)
Title
Radius of the radial retinal polarizer
Description
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
Time Frame
Approximately 30 minutes, on the completion of the study (Session 6)
Secondary Outcome Measure Information:
Title
Thickness of retina and retinal layers
Description
Measurement of the retinal layers' thickness and total neuroretina
Time Frame
Approximately 10 minutes, Screening and Training day (Session 1)
Title
Contrast sensitivity
Description
Computer-based measurement of contrast sensitivity
Time Frame
Approximately 5 minutes, Screening and Training day (Session 1)
Title
Fundus photography
Description
Imaging the retina using white light. The diameter of the optic nerve head will be measured in order to calculate the degree/pixel ratio for each participant
Time Frame
Approximately 5 minutes, Screening and Training day (Session 1)
Title
Ocular biometry measurement
Description
Measurement of the central corneal thickness and axial eye length
Time Frame
Approximately 5 minutes, Screening and Training day (Session 1)
Title
Macular pigment optical density measurement
Description
Computer-based measurement of the macular pigment optical density (MPOD)
Time Frame
Approximately 10 minutes, Screening and Training day (Sessions 1 and 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Participants with any additional eye diagnosis or condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Thompson, PhD
Phone
+852-3169-9631
Email
ben.thompson@cevr.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Mukhit Kulmaganbetov, MD, PhD
Phone
+852-3169-9631
Email
mukhit.k@cevr.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Thompson, PhD
Organizational Affiliation
Centre for Eye and Vision Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mukhit Kulmaganbetov, MD, PhD
Organizational Affiliation
Centre for Eye and Vision Research
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Eye and Vision Research Limited
City
Hong Kong
State/Province
Guangdong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter CK Pang, PhD
Phone
+852-2766-7927
Email
csm@cevr.hk
First Name & Middle Initial & Last Name & Degree
Taranjit Singh, BSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized data will be shared on request
IPD Sharing Time Frame
After the publication of study results for an indefinite period.
IPD Sharing Access Criteria
Upon reasonable request and approved by the study principal investigator.

Learn more about this trial

Direct Discrimination of Quantum States by the Human Eye

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