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
A study to assess the utility of human polarization pattern perception for the detection, diagnosis and monitoring of eye disease
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:
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:
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
Hypotheses:
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
phakic participants with no evidence of eye disorders
Diagnostic Test: polarization sensitivity
participants with cataract
Diagnostic Test: polarization sensitivity
participants with age related macular degeneration
Diagnostic Test: polarization sensitivity
particpiants who have had cataract surgery with intraocular lens implant
Diagnostic Test: polarization sensitivity
participants with macular ddisorders other than AMD
Diagnostic Test: polarization sensitivity
participants with diabetic retinopathy
Diagnostic Test: polarization sensitivity
test of polarization vision as described in Study Description
polarization sensitivity
determine and compare polarization sensitivity between groups
Time frame: 18 month
Plan to share: No
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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South Warwickshire NHS Foundation Trust