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.
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
- Conditions the study is for
- Cataract, Age Related Macular Degeneration, Pseudophakia
- 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.
United Kingdom1 site, 1 recruiting
- 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
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:
- that healthy subjects can perceive polarization stimuli
- 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:
- that eye conditions affect pVA/PPP
- that specific eye conditions have a selective effect on pVA/PPP
- 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
- to determine the repeatability of pVA/PPP testing in a heterogeneous patient group
- to determine the effect of cataract surgery on the pre-operative pVA/PPP results
- to determine if pVA/PPP is a useful determinant of post-operative visual outcome.
Hypotheses:
- that pVA/PPP testing is repeatable
- that there is a difference in pVA/PPP pre and post cataract surgery
- Conditions
- Cataract, Age Related Macular Degeneration, Pseudophakia, Macular Disease, Diabetic Retinopathy, Retinal Disease
- 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 group | Role | What they receive |
|---|---|---|
| Normal | phakic participants with no evidence of eye disorders Receives: Diagnostic Test: polarization sensitivity | |
| Cataract | participants with cataract Receives: Diagnostic Test: polarization sensitivity | |
| AMD | participants with age related macular degeneration Receives: Diagnostic Test: polarization sensitivity | |
| Pseudophakic | particpiants who have had cataract surgery with intraocular lens implant Receives: Diagnostic Test: polarization sensitivity | |
| other macula | participants with macular ddisorders other than AMD Receives: Diagnostic Test: polarization sensitivity | |
| DR | participants 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.
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.
- First posted30 Jan 2019
- Study start9 Nov 2017
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- South Warwickshire NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aston University
- Responsible party
- Principal investigator, Gary Misson, South Warwickshire NHS Foundation Trust
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 26291073Misson 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polarization Perception in Health and Disease. Testing a New Sight Test: The TaNSiT Study
- ClinicalTrials.gov ID
- NCT03823092
- Acronym / sponsor ID
- TaNSiT / 17/WA/0180
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- South Warwickshire NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Aston University
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the utility of human polarization pattern perception for the detection, diagnosis and monitoring of eye disease
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:
- that healthy subjects can perceive polarization stimuli
- 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:
- that eye conditions affect pVA/PPP
- that specific eye conditions have a selective effect on pVA/PPP
- 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
- to determine the repeatability of pVA/PPP testing in a heterogeneous patient group
- to determine the effect of cataract surgery on the pre-operative pVA/PPP results
- to determine if pVA/PPP is a useful determinant of post-operative visual outcome.
Hypotheses:
- that pVA/PPP testing is repeatable
- that there is a difference in pVA/PPP pre and post cataract surgery
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Diagnostic Test: polarization sensitivityphakic participants with no evidence of eye disorders |
| Cataract | – | Diagnostic Test: polarization sensitivityparticipants with cataract |
| AMD | – | Diagnostic Test: polarization sensitivityparticipants with age related macular degeneration |
| Pseudophakic | – | Diagnostic Test: polarization sensitivityparticpiants who have had cataract surgery with intraocular lens implant |
| other macula | – | Diagnostic Test: polarization sensitivityparticipants with macular ddisorders other than AMD |
| DR | – | Diagnostic Test: polarization sensitivityparticipants with diabetic retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and staff of the Eye Department of South Warwickshire NHS Trust
Key inclusion criteria (1 listed)
- willing and able to provide informed consent
Key exclusion criteria (2 listed)
- unwilling or unable to provide informed consent
- individuals wishing to exit the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polarization sensitivitytest of polarization vision as described in Study Description | Diagnostic test | AMD, Cataract, DR, Normal, Pseudophakic, other macula |
Primary outcome
polarization sensitivity
Time frame: 18 month
determine and compare polarization sensitivity between groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Results publication: PubMed 26291073Misson 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.
- Results publication: PubMed 29185499Misson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.