Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00317551
Status:
COMPLETED
Last Update Posted:
2006-10-17
First Post:
2006-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'lastUpdateSubmitDate': '2006-10-16', 'studyFirstSubmitDate': '2006-04-21', 'studyFirstSubmitQcDate': '2006-04-21', 'lastUpdatePostDateStruct': {'date': '2006-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in refractive error in myopia in 6 monthly intervals for 2 years'}, {'measure': 'Change in axial length in 6 monthly intervals for 2 years'}, {'measure': 'Age effects on refractive changes over 2 years'}], 'secondaryOutcomes': [{'measure': 'Change in accommodative response in 6 monthly intervals for 2 years'}, {'measure': 'Change in accommodative facility in 6 monthly intervals for 2 years'}, {'measure': 'Change in peripheral refraction in 6 monthly intervals for 2 years'}, {'measure': 'Change in AC/A ratio in 6 monthly intervals for 2 years'}]}, 'conditionsModule': {'keywords': ['Aberration control', 'Accommodative facility', 'Accommodative response', 'Peripheral refraction', 'Accommodative convergence to accommodation ratio'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression.', 'detailedDescription': 'Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical treatment that prevents progression. This study is a double masked placebo controlled block randomized clinical trial of two interventions, to treat accommodative factors we have identified as being significantly correlated to myopia progression (rather than to the presence of myopia). We have shown that the interventions normalise the accommodative factors, and this trial examines the effect of these interventions on myopia progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Best corrected visual acuity of 6/5 in each eye\n* Myopia in each meridian of at least 0.50 D\n* Willingness to give consent\n* Willingness to undertake any treatment option\n\nExclusion Criteria:\n\n* History of systemic/ocular pathology\n* History of any ocular surgery\n* More than 10D of myopia\n* Astigmatism more than 1.00 D'}, 'identificationModule': {'nctId': 'NCT00317551', 'briefTitle': 'Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development', 'organization': {'class': 'OTHER', 'fullName': 'Anglia Ruskin University'}, 'officialTitle': 'Accommodation Training and Aberration Control in Myopia Development', 'orgStudyIdInfo': {'id': 'VisionCRC-ARU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aberration controlled contact lens', 'type': 'DEVICE'}, {'name': 'Vision training', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB1 1PT', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Anglia Ruskin University', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': "Daniel J O'Leary, PhD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Wales Institute Cardiff'}, {'name': 'Peter M Allen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Anglia Ruskin University'}, {'name': 'Hema Radhakrishnan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}, {'name': 'Richard I Calver, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anglia Ruskin University'}, {'name': 'Ebi P Osuobeni, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anglia Ruskin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anglia Ruskin University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vision CRC', 'class': 'UNKNOWN'}]}}}