Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02814435
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Measures in Patients With Retinal Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012162', 'term': 'Retinal Degeneration'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of inherited retinal degeneration on quality of life measures.', 'timeFrame': 'May 2016 to May 2017', 'description': 'This will be assessed by comparing questionnaire results between different inherited retinal degeneration types.This will be determined by using ANOVA testing to compare scores caused by different genetic mutations, allowing us to relate mutations causing central versus peripheral visual loss to the quality of life measures.'}], 'secondaryOutcomes': [{'measure': 'Effect of contrast sensitivity function on quality of life.', 'timeFrame': 'May 2016 to May 2017', 'description': 'Contrast sensitivity function will be related to the questionnaire results using ANOVA testing \\& correlation analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retina', 'Retinal Degeneration', 'Quality of Life Measures'], 'conditions': ['Retinal Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ndcn.ox.ac.uk/divisions/nlo/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Inherited retinal degeneration (IRD) is a major cause of blindness and partial loss of vision cases in the UK and starts at an early age. The purpose of this observational study is to use the results of two questionnaires and a computerised test testing contrast sensitivity, to assess the impact of IRD on quality of life. This study will involve collecting data from patients with IRD, but also collecting data from normal controls.', 'detailedDescription': 'IRD presents a significant burden on the NHS as well as on the individual and families. IRDs are particularly difficult in a family situation due to guilt and other complex emotions related to inheritance patterns. Poorer mental health has been reported in patients with retinitis pigmentosa, manifesting in a range of ways including stress, depression and anxiety, particularly as the disease progresses. This is most probably caused by the uncertainty of the disease process and the progressive nature of the degeneration.\n\nRecent work has reported that quality of life significantly deteriorates with a drop in visual field diameter of 20 degrees or a drop in visual acuity lower then LogMAR 0.3 (equivalent to 6/12). Contrast sensitivity is often used in conjunction with VA to assess visual capabilities. It is a measure of the ability to see reduced contrast and has a major impact on utility of vision. Relating contrast sensitivity function to quality of life will provide valuable information about whether this aspect of vision is a critical measure for patient health. This is especially important as novel treatments are being developed for the treatment of IRDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients with inherited retinal degeneration will be recruited from the outpatient clinic in the Oxford Eye Hospital. 30 healthy controls will be recruited from advertising around the OUH hospitals and the University of Oxford.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing \\& able to give informed consent for participation in the study.\n* Male or female, aged 18 - 85.\n* A clinical or genetic diagnosis of retinal degeneration or normal age and sex-matched controls without known retinal disease.\n* Able to participate in visual function testing.\n\nExclusion Criteria:\n\n* The participant may not enter the study if any of the following apply:\n\n * 1\\) they have a pre-existing amblyopia or squint;\n * 2\\) they have any other retinal problems that may confound the measures assessed.'}, 'identificationModule': {'nctId': 'NCT02814435', 'briefTitle': 'Quality of Life Measures in Patients With Retinal Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Quality of Life Measures in Patients With Retinal Degeneration', 'orgStudyIdInfo': {'id': 'QoLMeasuresIRD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with inherited retinal degeneration will answer two questionnaires and undergo a computerised contrast sensitivity function test.', 'interventionNames': ['Other: Questionnaire', 'Other: Computerised contrast sensitivity function test']}, {'label': 'Normal controls', 'description': 'Normal controls recruited by advertising will answer two questionnaires and undergo a computerised test that assess contrast sensitivity function.', 'interventionNames': ['Other: Questionnaire', 'Other: Computerised contrast sensitivity function test']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'The participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision).', 'armGroupLabels': ['Normal controls', 'Patients']}, {'name': 'Computerised contrast sensitivity function test', 'type': 'OTHER', 'description': 'This test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity.', 'armGroupLabels': ['Normal controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Eye Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Jasleen K Jolly, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}