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Status unknownNCT03823092TaNSiTUpdated Jan 30, 2019

Polarization Perception in Health and Disease. Testing a New Sight Test

An observational study in Cataract, Age Related Macular Degeneration and Pseudophakia, sponsored by South Warwickshire NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by South Warwickshire NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years and older
Sex
All
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Study summary

A study to assess the utility of human polarization pattern perception for the detection, diagnosis and monitoring of eye disease

Read the detailed description

The recently described high sensitivity of the human eye to differentiate small angular differences in linear polarization and evidence supporting its macular origin (Misson, Anderson; 2017) suggests that human polarization sensitivity might be a useful diagnostic tool for macular disease. This augments a previous study in which we demonstrated the ability of the human visual system to detect isochromatic isoluminant polarization modulated pattern stimuli (Misson et al 2015).

This is an exploratory 'proof-of-concept' study to determine the clinical value of polarization pattern perception, PPP, in health and disease. We further propose that PPP might be valuable for the diagnosis, monitoring and early detection of macular disease. The latter includes common blinding conditions such as age related macular degeneration and diabetic retinopathy. It is also intended to investigate the effect of cataracts and cataract surgery on PPP: cataract surgery modifies the optics of the eye so might also modify PPP.

PPP is measured using a modification of the methodology described in (Misson et al 2015) and (Misson, Anderson; 2017) whereby polarization modulated patterns are presented on a modified LCD display. The observer's task is to report if they see an image and to describe the image. Images comprise simple patterns or traditional optotypes. A standard set of images are presented in pseudorandom order and the response recorded. A total score, the polarization pattern perception score PPP is then determined from the number of images seen/identified. A more refined metric, the polarization visual acuity pVA, will be derived from the response to the optotype stimuli. These data are then compared to conventional tests of visual structure and function including logMAR visual acuity, ocular examination and OCT scan data.

The study in anticipated to comprise:

Phase 1. Normative Evaluation: observational prospective cross-sectional.. A preliminary normative study will be undertaken on staff members. The aim is to quantify normative values in preparation for the clinical studies.

Hypotheses to be tested:

  1. that healthy subjects can perceive polarization stimuli
  2. that there is a threshold of polarization image resolution (pVA) analogous to visual acuity. Normative PPP and pVA data will be collected.

Phase 2 Patient Group: observational Prospective cross-sectional / case-control.

Phase 2 subjects will comprise normals and patients with cataracts/pseudophakia and/or AMD, other macular pathology, diabetic retinopathy..

The aim of this phase is to determine the effect, if any, of particular eye conditions on pVA/PPP alone and in comparison with other test parameters.

Hypotheses to be tested:

  1. that eye conditions affect pVA/PPP
  2. that specific eye conditions have a selective effect on pVA/PPP
  3. that pseudophakia affects pVA/PPP

Phase 3: Cataract pre-op v post op pVA/PPP: prospective interventional case-control.

Timescale:concurrent with Phase 2 A subset of the phase 2 cataract patients will undergo cataract surgery according to clinical need. These patients are routinely reviewed 4 - 8 weeks post-op when the opportunity will arise to repeat pVA/PPP measurement. The fellow eye will serve as a control / provide data for repeatability assessment.

The aims of this phase are

  1. to determine the repeatability of pVA/PPP testing in a heterogeneous patient group
  2. to determine the effect of cataract surgery on the pre-operative pVA/PPP results
  3. to determine if pVA/PPP is a useful determinant of post-operative visual outcome.

Hypotheses:

  1. that pVA/PPP testing is repeatable
  2. that there is a difference in pVA/PPP pre and post cataract surgery
02

Conditions studied

  • Cataract
  • Age Related Macular Degeneration
  • Pseudophakia
  • Macular Disease
  • Diabetic Retinopathy
  • Retinal Disease

Keywords

  • macular function
  • polarization perception
  • Haidinger's brush
  • vision testing
  • cataract
  • age related macular degeneration
  • pseudophakia
  • macular disease
  • retinal disease
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 300 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

South Warwickshire NHS Foundation Trust is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients and staff of the Eye Department of South Warwickshire NHS Trust

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • willing and able to provide

Exclusion criteria

Exclusion Criteria:

  • unwilling or unable to provide
  • individuals wishing to exit the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Normal

    phakic participants with no evidence of eye disorders

    Diagnostic Test: polarization sensitivity

  • Cataract

    participants with cataract

    Diagnostic Test: polarization sensitivity

  • AMD

    participants with age related macular degeneration

    Diagnostic Test: polarization sensitivity

  • Pseudophakic

    particpiants who have had cataract surgery with intraocular lens implant

    Diagnostic Test: polarization sensitivity

  • other macula

    participants with macular ddisorders other than AMD

    Diagnostic Test: polarization sensitivity

  • DR

    participants with diabetic retinopathy

    Diagnostic Test: polarization sensitivity

Interventions

  • Diagnostic testpolarization sensitivity

    test of polarization vision as described in Study Description

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What researchers measure

Primary outcomes

  1. polarization sensitivity

    determine and compare polarization sensitivity between groups

    Time frame: 18 month

07

Study locations

1 of 1 sites recruiting
  • South Warwickshire NHS Foundation Trust
    Warwick, Warwickshire CV37 0PZ, United Kingdom
    Recruiting
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References and documents

Publications

  • Misson GP, Timmerman BH, Bryanston-Cross PJ. Human perception of visual stimuli modulated by direction of linear polarization. Vision Res. 2015 Oct;115(Pt A):48-57. doi: 10.1016/j.visres.2015.08.004. Epub 2015 Aug 28. PubMed 26291073 ↗
  • Misson GP, Anderson SJ. The spectral, spatial and contrast sensitivity of human polarization pattern perception. Sci Rep. 2017 Nov 29;7(1):16571. doi: 10.1038/s41598-017-16873-6. PubMed 29185499 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03823092
Lead sponsor
South Warwickshire NHS Foundation Trust
Collaborators
Aston University
Responsible party
Gary Misson (Consultant ophthalmologist, South Warwickshire NHS Foundation Trust) — Principal investigator
First posted
Jan 30, 2019
Start date
Nov 9, 2017
Primary completion
Apr 2019 (estimated)
Completion
Jul 2019 (estimated)
Last update
Jan 30, 2019

Study contacts

Gary P Misson, PhD FRCOphth
Contact
gary.misson@swft.nhs.uk
+44 01926495321
Jo Williams
Contact
jo.williams@swft.nhs.uk
+44 01926495321

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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