Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-29 @ 5:02 PM
Study NCT ID:
NCT01701700
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2012-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'usage of magnifiers', 'timeFrame': 'Change from baseline at 2 months and 4 months', 'description': 'Use of Manchester Low Vision Questionnaire to quantify device usage'}, {'measure': 'reading speed', 'timeFrame': 'Change from baseline at 2 months and 4 months', 'description': 'Reading speed using the device assessed by MNREAD test'}], 'secondaryOutcomes': [{'measure': 'speed of performance of activities of daily living', 'timeFrame': 'Change from baseline at 2 months and 4 months', 'description': 'total time taken to performance 5 selected activities of daily living using aids if required'}, {'measure': 'difficulty with near vision activities', 'timeFrame': 'Change from baseline at 2 months and 4 months', 'description': 'Use of NV-VFQ-15 questionnaire to self-rate difficulty in performance of near vision activities'}, {'measure': 'health related quality of life', 'timeFrame': 'Change from baseline at 2 months and 4 months', 'description': 'Use of EQ-5D and VISQOL questionnaires to self-rate health-related quality of life'}, {'measure': 'well-being', 'timeFrame': 'Change from baseline at 2 months and 4 months', 'description': 'use of WHO-5 questionnaire to self-rate wellbeing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['portable electronic magnifiers'], 'conditions': ['Moderate or Severe Vision Impairment, Both Eyes']}, 'descriptionModule': {'briefSummary': 'Over 1 million people in the UK suffer from untreatable visual impairment, many of them elderly. The major complaint of visually impaired people is their inability to carry out simple tasks, especially those involving reading. It is known that this activity limitation is a major cause of depression in an older population, and it is reflected in reduced quality of life. Low vision clinics, mostly based within hospital ophthalmology departments, dispense optical magnifiers to allow patients to carry out these tasks again, but these devices do have limitations (unusual posture, short working distance, monocular viewing). Although electronic magnifiers have been around since the 1960s, they were initially very large and expensive. Recent advances in technology have brought about an explosion in the number and range of portable and moderately-priced aids, which can be used binocularly, in a natural working position: these are currently not available through the NHS. Evidence is needed as to whether these portable hand-held electronic magnifiers could offer a significant benefit to the majority of patients, and therefore whether they should be routinely dispensed in low vision clinics.\n\nThe proposed study is a two-arm randomised crossover trial with existing users of optical magnifiers being assigned to use a hand-held electronic magnifier in addition to their existing devices for 2 months. Reading and task performance will be measured with the aid, and compared to the performance with optical aids, and the patient will be asked to report on the comparisons between the aids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of Manchester Royal Eye Hospital\n* Visual impairment secondary to range of stable ocular pathologies (no change in VA \\> 2 lines in previous 6 months)\n* Currently possess a near vision optical magnifying device.\n* VA \\<= 6/30 (\\<=0.7 logMAR) and/or log contrast sensitivity \\<=1.20\n\nExclusion Criteria:\n\n* Current use of personal EVES device\n* Hearing inadequate to respond to verbal instruction\n* Habitual language not English\n* A physical disability preventing the participant from operating the device\n* A score of less than 19 on the Mini-Mental State Examination'}, 'identificationModule': {'nctId': 'NCT01701700', 'acronym': 'p-EVES', 'briefTitle': 'The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Manchester University NHS Foundation Trust'}, 'officialTitle': 'The Effectiveness of Portable Electronic Vision Enhancement Systems (EVES) in Comparison to Optical Magnifiers for Near Vision Activities in Visual Impairment - The p-EVES Study', 'orgStudyIdInfo': {'id': 'PB-PG-0211-24105'}, 'secondaryIdInfos': [{'id': 'R01715', 'type': 'OTHER', 'domain': 'CMFT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'portable electronic magnifier', 'description': 'Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months', 'interventionNames': ['Procedure: portable electronic magnifier', 'Procedure: optical aids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'optical aids', 'description': 'Use of existing optical aids for 2 months', 'interventionNames': ['Procedure: optical aids']}], 'interventions': [{'name': 'portable electronic magnifier', 'type': 'PROCEDURE', 'otherNames': ['electronic video magnifier', 'portable CCTV', 'electronic vision enhancement system', 'EVES'], 'armGroupLabels': ['portable electronic magnifier']}, {'name': 'optical aids', 'type': 'PROCEDURE', 'otherNames': ['magnifiers'], 'armGroupLabels': ['optical aids', 'portable electronic magnifier']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Eye Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Chris M Dickinson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'University of Manchester', 'class': 'OTHER'}, {'name': 'Cardiff University', 'class': 'OTHER'}, {'name': 'Bangor University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}