Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 10:45 AM
Study NCT ID:
NCT05772793
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telerehabilitation for Visually Impaired
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Utility of EyeFitness telerehabilitation', 'timeFrame': '6 months', 'description': 'The aim of this study is to evaluate the utility of the EyeFitness telerehabilitation software and the adherence of patients to the treatment.\n\nIn order to evaluate the utility of the software the primary outcome measures were PSSUQ Version 3 scores defined as Overall, System Usefulness (Sysuse), Information Quality (Infoqual), Interface Quality (Iterqual).'}], 'secondaryOutcomes': [{'measure': 'Effect of treatment', 'timeFrame': '6 months', 'description': 'The secondary outcome measures selected for the effectiveness analysis were distance Best Corrected Visual Acuity, MNRead reading acuity, reading speed (words per minute), contrast sensitivity (at Pelli - Robson charts) and fixation stability according to Microperimeter exame classification.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Visual Impairment']}, 'descriptionModule': {'briefSummary': "the purpose of the study is to evaluate the software usability and patient's adherence from five vision rehabilitation centres. In addition, the effect and benefits of a customizable telerehabilitation program were tested.", 'detailedDescription': 'The software is used in our practice for every day vision rehabilitation training.\n\nSo it is part of our routine medical care, and a we are going to study studies the effect of the intervention in several different centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients were eligible if they were over 18 years old and had a best corrected visual acuity (BCVA) between 1.3 logMAR and 0.4 LogMAR and/or a visual field of less than 60%, according to the WHO classification.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients were eligible if they were over 18 years old and had a best corrected visual acuity (BCVA) between 1.3 logMAR and 0.4 LogMAR and/or a visual field of less than 60%, according to the WHO classification.\n\nExclusion Criteria:\n\n* Subjects were excluded if they had a cognitive/psychiatric impairment or a motor disability that prevents the use of a computer pointing device (mouse).'}, 'identificationModule': {'nctId': 'NCT05772793', 'briefTitle': 'Telerehabilitation for Visually Impaired', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Usability and Adherence of Visually Impaired to Telerehabilitation: a Multicentre Study', 'orgStudyIdInfo': {'id': '4244'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'interventionNames': ['Device: Telerehabilitation']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'DEVICE', 'description': 'The home visual telerehabilitation path using the EyeFitness software consisted of performing one visual training session per day, 5 days a week (from Monday to Friday) for a total of 6 weeks.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amore Filippo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Amore Filippo', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}