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CataractTaNSiTNCT03823092

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

An observational study of Cataract and Age Related Macular Degeneration, run by South Warwickshire NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
polarization sensitivity
How many people
300 participants
Where
1 siteUnited Kingdom
Study dates
9 Nov 2017to Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients and staff of the Eye Department of South Warwickshire NHS Trust

Who may be able to join

  • willing and able to provide informed consent

Who cannot join

  • unwilling or unable to provide informed consent
  • individuals wishing to exit the study

Trial locations and contacts

1 site in 1 country.

Gary P Misson, PhD FRCOphth contact

+44 01926495321

gary.misson@swft.nhs.uk

United Kingdom1 site, 1 recruiting
  • South Warwickshire NHS Foundation Trust

    Warwick, Warwickshire, CV37 0PZ

    Gary P Misson, PhD FRCOphth, +44 01926495321, gary.misson@swft.nhs.uk

    Jo Williams, +44 01926495321, jo.williams@swft.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Polarization Perception in Health and Disease. Testing a New Sight Test: The TaNSiT Study

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
Being tested
polarization sensitivity
Keywords
macular function, polarization perception, Haidinger's brush, vision testing, cataract, age related macular degeneration, pseudophakia, macular disease, retinal disease
Medical subject headings
Cataract, Macular Degeneration, Pseudophakia, Diabetic Retinopathy, Retinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • polarization sensitivityDiagnostic test

    test of polarization vision as described in Study Description

Study groups in NCT03823092
Study groupRoleWhat they receive
Normalphakic participants with no evidence of eye disorders
Receives: Diagnostic Test: polarization sensitivity
Cataractparticipants with cataract
Receives: Diagnostic Test: polarization sensitivity
AMDparticipants with age related macular degeneration
Receives: Diagnostic Test: polarization sensitivity
Pseudophakicparticpiants who have had cataract surgery with intraocular lens implant
Receives: Diagnostic Test: polarization sensitivity
other maculaparticipants with macular ddisorders other than AMD
Receives: Diagnostic Test: polarization sensitivity
DRparticipants with diabetic retinopathy
Receives: Diagnostic Test: polarization sensitivity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. polarization sensitivity

    determine and compare polarization sensitivity between groups

    Measured: 18 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start9 Nov 2017
  3. Primary completionApr 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03823092
Sponsor's protocol ID
17/WA/0180
Acronym
TaNSiT
Status last verified
Jan 2019
First submitted
28 Jan 2019
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Age Related Macular Degeneration, run by South Warwickshire NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gary P Misson, PhD FRCOphth (+44 01926495321, gary.misson@swft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

polarization sensitivity (time frame: 18 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03823092, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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