Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT05684302
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2022-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2022-12-24', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The clarity score', 'timeFrame': 'baseline visit time', 'description': 'The clarity score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better'}, {'measure': 'The comfort score', 'timeFrame': 'baseline visit time', 'description': 'The comfort score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better'}], 'secondaryOutcomes': [{'measure': 'Accuracy of foveal and peripheral visual acuity', 'timeFrame': 'baseline visit time', 'description': 'Accuracy of foveal and peripheral visual acuity was assessed by the eye movement tracking device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia', 'Refractive Errors']}, 'referencesModule': {'references': [{'pmid': '31222837', 'type': 'BACKGROUND', 'citation': 'Jalie M. Modern spectacle lens design. Clin Exp Optom. 2020 Jan;103(1):3-10. doi: 10.1111/cxo.12930. Epub 2019 Jun 20.'}, {'pmid': '32749325', 'type': 'BACKGROUND', 'citation': 'Gannon C, Liang R. Evolving expertise for automated lens optimization. Appl Opt. 2020 Aug 1;59(22):G129-G136. doi: 10.1364/AO.391888.'}]}, 'descriptionModule': {'briefSummary': 'A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population.', 'detailedDescription': 'A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. The subjective visual quality of clarity and comfort were determined using a questionnaire when first wearing the glasses and after 1week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy myopic people between 18 and 50 years of age', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* health volunteers\n* their spherical refraction from -0.50 to -8.00 Diopter, with the cylinder diopter less than -3.00 Diopter\n* best corrected visual acuity (BCVA)≥ 20/20 in both eyes\n* stable refraction (no change greater than 0.5 Diopter within two years)\n\nExclusion Criteria:\n\n* if they had Aphakic or intraocular lens eyes, had a history of trauma, active eye disease or ocular surgery, serious systemic diseases, or had a wearing history of corneal contact lenses.'}, 'identificationModule': {'nctId': 'NCT05684302', 'briefTitle': 'The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population', 'orgStudyIdInfo': {'id': 'KY202101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'The free-toroidal design lenses', 'type': 'OTHER', 'description': 'Participants were asked to wear the new design lenses (the free-toroidal design lenses) for 1 week'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}