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Dual Wavelength OCT

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ClinicalTrials.gov Identifier: NCT03843840
Recruitment Status : Unknown
Verified February 2019 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

Brief Summary:
The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged.

Condition or disease Intervention/treatment
AMD Diabetic Retinopathy Retinal Degeneration Retinal Dystrophies Device: Combined Coaxial Optical Coherence Tomography

Detailed Description:
Histology studies have shown that many disorders of the retina and choroid such as age-related macular degeneration is associated with a build up abnormal deposits, in the retina or subretinal space. Being able to detect subtle changes in retina and choroidal structure is crucial for better understanding and monitoring of this potentially blinding condition. This study aims to commercially available Spectralis® OCT-system with a central wavelength of 880nm explore the ability of a confocal scanning laser ophthalmoscope (cSLO) for OCT imaging utilising a modified by the addition of a longer wavelength OCT (1075nm , a wavelength deployed on other commercially available OCT scanners). Other commercially available OCT scanners used longer wavelengths to allow deeper penetration and enhanced visualisation of subretinal tissue but less inner retinal detail. Combing both wavelengths could have the advantage of allowing optimum viualisation of inner and subretinal structures. The ability of the systems to acquire repeatable and good quality images of retinal and choroidal structural detail at matching location and compare the results from the two instruments will be evaluated. In addition processing of the images reflectivity with two different wavelength should give us insight into the nature of any abnormal material.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Combined Coaxial Optical Coherence Tomography System to Image the Retina and Choroidal Structures and Estimate Tissue Reflectivity in Healthy and Diseased Retinas
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : September 30, 2019

Group/Cohort Intervention/treatment
Diseased Retina Device: Combined Coaxial Optical Coherence Tomography
Taking images of the retina with two wavelengths




Primary Outcome Measures :
  1. Test retest reliability [ Time Frame: 14 months ]
    Comparison of device test retest variability with those of standard OCT for measurement of tissue reflectivity.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with diseased retina
Criteria

Inclusion Criteria:

  • Age>18
  • Ability to consent
  • Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine
  • clinical care

Exclusion Criteria:

  • Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of
  • the retina and/or choroidal substructures in the opinion of the investigator
  • Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843840


Contacts
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Contact: Adnan Tufail 020 7253 3411 ext 2036 adnan.tufail@nhs.net

Locations
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United Kingdom
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road Recruiting
London, United Kingdom, EC1V 2PD
Contact: Tania West    020 7253 3411    moorfields.resadmin@nhs.net   
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
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Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03843840    
Other Study ID Numbers: TUFA1040
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Retinopathy
Retinal Degeneration
Retinal Dystrophies
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases, Hereditary