- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05913063
Direct Discrimination of Quantum States by the Human Eye
Direct Discrimination of Quantum States by the Human Eye With Macular Degeneration
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benjamin Thompson, PhD
- Phone Number: +852-3169-9631
- Email: ben.thompson@cevr.hk
Study Contact Backup
- Name: Mukhit Kulmaganbetov, MD, PhD
- Phone Number: +852-3169-9631
- Email: mukhit.k@cevr.hk
Study Locations
-
-
Guangdong
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Hong Kong, Guangdong, Hong Kong, 00000
- Recruiting
- Centre for Eye and Vision Research Limited
-
Contact:
- Peter CK Pang, PhD
- Phone Number: +852-2766-7927
- Email: csm@cevr.hk
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Sub-Investigator:
- Taranjit Singh, BSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants with Age-Related Macular Degeneration
Conducting the psychophysical task on the perception of OAM-coupled polarized light
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of the structured light
Time Frame: Approximately 10 minutes, Screening and Training day (Session 1)
|
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
Time Frame: Approximately 30 minutes, on the completion of the study (Session 6)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thickness of retina and retinal layers
Time Frame: Approximately 10 minutes, Screening and Training day (Session 1)
|
Measurement of the retinal layers' thickness and total neuroretina
|
Approximately 10 minutes, Screening and Training day (Session 1)
|
Contrast sensitivity
Time Frame: Approximately 5 minutes, Screening and Training day (Session 1)
|
Computer-based measurement of contrast sensitivity
|
Approximately 5 minutes, Screening and Training day (Session 1)
|
Fundus photography
Time Frame: Approximately 5 minutes, Screening and Training day (Session 1)
|
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
|
Approximately 5 minutes, Screening and Training day (Session 1)
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Ocular biometry measurement
Time Frame: Approximately 5 minutes, Screening and Training day (Session 1)
|
Measurement of the central corneal thickness and axial eye length
|
Approximately 5 minutes, Screening and Training day (Session 1)
|
Macular pigment optical density measurement
Time Frame: Approximately 10 minutes, Screening and Training day (Sessions 1 and 2)
|
Computer-based measurement of the macular pigment optical density (MPOD)
|
Approximately 10 minutes, Screening and Training day (Sessions 1 and 2)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benjamin Thompson, PhD, Centre for Eye and Vision Research
- Study Director: Mukhit Kulmaganbetov, MD, PhD, Centre for Eye and Vision Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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