Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT06912802
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Group 1 respondents' assessment of EQ-5D-Y-3L (proxy)", 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia.\n\nThe EQ-5D-Y-3L (European Quality of Life 5 Dimensions 3 Level) proxy version is an instrument used to assess health-related quality of life (HRQoL) of children and adolescents from the perspective of a parent, caregiver or another proxy. It uses a three-level scale (no problems, some problems or a lot of problems) along with a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). The EQ-5D-Y-3L value sets will be used to calculate utility values.'}, {'measure': "Group 1 respondents' assessment of Bolt-on vision", 'timeFrame': 'Through study completion, an average of 6 months', 'description': "Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia.\n\nThe vision bolt-on assessment is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life and consists of a single question in the same format."}, {'measure': "Group 1 respondents' assessment of PedEyeQ (Pediatric Eye Questionnaire)", 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia.\n\nThe PedEyeQ (Pediatric Eye Questionnaire) proxy version is a HRQoL (Health Related Quality of Life) assessment tool specifically designed to measure the impact of pediatric eye conditions on children. The tool consists of age-appropriate questionnaires (5-11 years old and 12-17 years old) that assess how vision problems affect daily activities, social interactions, school performance, and overall well-being of the child.'}, {'measure': "Group 2 respondents' assessment of EQ-5D-5L", 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia.\n\nThe EQ-5D-5L (European Quality of Life 5 Dimensions 3 Level) includes five questions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This questionnaire will be administered to adults suffering from myopia plus a complication. Each domain is rated from 1 (best quality) to 5 (worst quality), along with a VAS from 0 (worst imaginable health) to 100 (best imaginable health).'}, {'measure': "Group 2 respondents' assessment of Bolt-on vision", 'timeFrame': 'Through study completion, an average of 6 months', 'description': "Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia.\n\nThe vision bolt-on is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life. The EQ-5D-5L value sets will be used to calculate utility values for adults with myopia and its complications."}, {'measure': "Group 2 respondents' assessment of NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25)", 'timeFrame': 'Through study completion, an average of 6 months', 'description': "Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia.\n\nThe NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25) is a tool used to assess VRQoL (Vision Related Quality of Life) in individuals aged 18 and older. It consists of 25 items that measure the impact of vision impairment on daily activities and well-being across 12 domains, including visual function, mental health, social functioning, and role limitations. The NEI-VFQ-25 helps evaluate how visual problems affect a person's ability to perform tasks like reading, driving, and interacting socially."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the impact of myopia in childhood and its long-term complications in adulthood on health-related Quality of Life (HRQoL), providing valuable data for cost-effectiveness models. It will gather country-specific information on healthcare resource utilization, including treatment costs, access to care, and reimbursement policies. In addition, the study will examine how myopia and its treatments affect daily activities and evaluate treatment satisfaction. No data on the efficacy of myopia treatments is collected in this study, and neither is the occurrence of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) and adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents (or other proxy) of children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) defined by their spherical equivalent (SER): Low myopia is from -0.5 D (inclusive) to -3.0 D (inclusive), Moderate myopia is from -3.0 D to -6.0 D (inclusive) and High myopia is \\<-6.0 D.\n* Adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.\n* Patients where myopia is a known or likely contributing factor to the complication.\n\nExclusion Criteria:\n\n* Parents (or other proxy) of children aged 4 years and below.\n* Patients where the complication is likely unrelated to myopia (e.g., cataract caused by diabetes) will be excluded'}, 'identificationModule': {'nctId': 'NCT06912802', 'briefTitle': 'Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen SAS'}, 'officialTitle': 'Non-interventional Study to Assess the Impact of Myopia in Childhood and the Long-Term Complications in Adulthood on Health-Related Quality of Life (HRQoL).', 'orgStudyIdInfo': {'id': 'PMA-HEOR-QoL-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Childhood Myopia', 'description': 'Parents (or other proxy) of children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) defined by their refractive error;', 'interventionNames': ['Other: Non-Intervention']}, {'label': 'Adulthood Myopia + Long-Term Complication', 'description': 'Adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.', 'interventionNames': ['Other: Non-Intervention']}], 'interventions': [{'name': 'Non-Intervention', 'type': 'OTHER', 'description': 'Non-Intervention study', 'armGroupLabels': ['Adulthood Myopia + Long-Term Complication', 'Childhood Myopia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Prof. Kessel', 'role': 'CONTACT'}], 'facility': 'Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr. Bremond-Gignac', 'role': 'CONTACT'}], 'facility': 'University Hospital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Freiburg im Breisgau', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dr. Wolf Lagrèze', 'role': 'CONTACT'}], 'facility': 'Klinik für Augenheilkunde (Universitätsklinikum Freiburg)', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Mainz', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dr. Alexander Schuster', 'role': 'CONTACT'}], 'facility': 'Universitäts-Augenklinik Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Prof Caputo', 'role': 'CONTACT'}], 'facility': "Meyer Children's Hospital IRCCS", 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Rome', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Dr. Rizzo', 'role': 'CONTACT'}], 'facility': 'Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Dr. Donate', 'role': 'CONTACT'}], 'facility': 'Estudio Oftalmologico', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Dr. Guemes', 'role': 'CONTACT'}], 'facility': 'The San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Solna', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Dr. Epstein', 'role': 'CONTACT'}, {'name': 'Dr. Lofgren', 'role': 'CONTACT'}], 'facility': 'St. Erik Eye Hospital', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dr. Annegret Dahlmann-Noor', 'role': 'CONTACT'}], 'facility': 'Moorfields Eye Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Santen sas Clinical Operations', 'role': 'CONTACT', 'email': 'clinicaltrials@santen.com', 'phone': '5106851794'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}