Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04274634
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oscillation of Crystalline and Intraocular Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017889', 'term': 'Exfoliation Syndrome'}, {'id': 'D002386', 'term': 'Cataract'}, {'id': 'D004479', 'term': 'Ectopia Lentis'}], 'ancestors': [{'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005124', 'term': 'Eye Abnormalities'}, {'id': 'D007906', 'term': 'Lens Subluxation'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the feasibility of implementing a larger study', 'timeFrame': '1 year', 'description': 'Criteria: number of eligible participants.This can then inform the sample size calculation for the larger study.'}], 'secondaryOutcomes': [{'measure': 'Assessing lens oscillation amplitude in different patient populations using a non-invasive, high-speed camera', 'timeFrame': '1 year', 'description': 'The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: amplitude, which will be compared across the six patient population groups.'}, {'measure': 'Assessing lens oscillation ("wobbliness") by oscillation frequency in different patient populations using a non-invasive, high-speed camera', 'timeFrame': '1 year', 'description': 'The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: oscillation frequency, which will be compared across the six patient population groups.'}, {'measure': 'Assessing lens oscillation by damping ratio in different patient populations using a non-invasive, high-speed camera', 'timeFrame': '1 year', 'description': 'The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: damping ratio, which will be compared across the six patient population groups.'}, {'measure': 'Assessing lens oscillation by the stationary time in different patient populations using a non-invasive, high-speed camera', 'timeFrame': '1 year', 'description': 'The measurement tool is a non-invasive, high-speed camera device that is used to assess lens oscillations has been made for this purpose by one of the co investigators. The device measures lens oscillations in a quantitative way, being much simpler and more accurate compared to previous qualitative assessments. The outcome measure, lens oscillation, is measured by: stationary time, which will be compared across the six patient population groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Marfan's Syndrome With Ocular Manifestations", 'Pseudoexfoliation Syndrome', 'Cataract', 'Phakodonesis', 'Ectopia Lentis']}, 'descriptionModule': {'briefSummary': 'The crystalline lens of the human eye helps to sharpen vision. There can be issues with the support/stability of the lens. This could be seen with the naked eye of an external observer or with the use of a slit lamp.\n\nCertain eye conditions can predispose to issues with lens stability. If patients have stability issues with their natural lens- this would be termed as "phakodonesis". However, in patients who have had prior cataract surgery with implantation of an artificial lens (IOL)- this would be termed as "pseudophakodonesis". Eye conditions such as pseudoexfoliation or Marfan-syndrome can lead to unstable lens support- this can be detected if there are advanced stability issues.\n\nHowever, small instability in the eye\'s would not be detected with present descriptive methods. The authors have designed a high-speed camera which is able to detect stability of the lens, especially during eye movements. The high-speed camera can detect variation in the change of light reflex from the lens and calculate the amount of lens instability/oscillation. The results (in normal eyes) of this high-speed camera has already been published in a peer-review journal. It is non-contact and measures lens movement. The test lasts less than 5 minutes.\n\nFurther research is required to assess the amount of lens oscillation (wobbling) in different eye populations - patients with previous cataract surgery (an artificial implant is used to replace the lens) or eye conditions (such as pseudoexfoliation, Marfan syndrome). The amount of lens stability has a role in the planning of further intraocular surgery - especially cataract extraction - however, at present, there is no approved quantitative measurement for this.\n\nParticipants will be recruited through Anglia Ruskin University (educational establishment), local community groups, and through Southend University Hospital eye clinics (NHS organisation). Participants\' data will remain anonymous.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary care, community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* Able to read and understand the English language\n\nExclusion Criteria:\n\n* Significant corneal scarring\n* Taking medications that cause miosis (pupil constriction)\n* Patients with no light perception\n* Patients unable to open their eyes e.g. due to significant ptosis'}, 'identificationModule': {'nctId': 'NCT04274634', 'briefTitle': 'The Oscillation of Crystalline and Intraocular Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Anglia Ruskin University'}, 'officialTitle': "The Oscillation of Crystalline and Intraocular Lenses: a Feasibility Study of the Lens' Movements in the Eye", 'orgStudyIdInfo': {'id': 'OSCCIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conditions with predisposition to lens oscillations', 'description': 'Marfan Syndrome and Pseudoexfoliation'}, {'label': 'Age-matched with normal axial lengths'}, {'label': 'Age-matched with extreme axial lengths'}, {'label': 'Intraocular lens'}, {'label': 'Pre- and post- cataract surgery'}, {'label': 'Normals'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS0 0RY', 'city': 'Southend-on-Sea', 'state': 'Essex', 'country': 'United Kingdom', 'contacts': [{'name': 'Craig Mackerness', 'role': 'CONTACT', 'email': 'craig.mackerness@southend.nhs.uk', 'phone': '01702 385089'}, {'name': 'Aman Chandra', 'role': 'CONTACT', 'email': 'aman.chandra@southend.nhs.uk'}], 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.53782, 'lon': 0.71433}}, {'zip': 'CB1 2LZ', 'city': 'Cambridge', 'country': 'United Kingdom', 'contacts': [{'name': 'Megan H Vaughan', 'role': 'CONTACT', 'email': 'megan.vaughan@pgr.anglia.ac.uk', 'phone': '01223695310'}, {'name': 'Shahina Pardhan', 'role': 'CONTACT'}], 'facility': 'Vision and Eye Research Institute (VERI)', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anglia Ruskin University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mid and South Essex NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}