Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 4:37 AM
Study NCT ID:
NCT05373693
Status:
UNKNOWN
Last Update Posted:
2022-05-13
First Post:
2022-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia-control Efficacy by Peripheral Defocus Lens (PDL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047728', 'term': 'Myopia, Degenerative'}], 'ancestors': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2022-04-15', 'studyFirstSubmitQcDate': '2022-05-09', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in cycloplegic objective spherical equivalent (SER)', 'timeFrame': 'baseline, 24 months', 'description': 'changes in cycloplegic objective spherical equivalent (SER) from baseline between four groups.'}], 'secondaryOutcomes': [{'measure': 'changes in ocular axial length', 'timeFrame': 'baseline, 24 months', 'description': 'Changes in ocular axial length from baseline between four groups.'}, {'measure': 'visual performance', 'timeFrame': '1 day', 'description': 'The visual acuity of peripheral between four groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia, Progressive']}, 'descriptionModule': {'briefSummary': 'The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.', 'detailedDescription': 'The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are planned. First, objective testing will be utilized to assess the effect of Bestivue PDL lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 D power and single vision lenses.In the second stage, the same children participants will wear either single or Bestvue PDL lenses with one of the four plus power designs for 2 years. Their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. Outcomes of these studies should inform whether Bestivue PDL lenses are effective in myopia control while affording adequate visual comfort and performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects had spherical RE of -1.00 to -6.00 D\n* Astigmatism ≤ 4.00 D\n* Anisometropia ≤ 1.50 D\\\\\n* Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.\n\nExclusion Criteria:\n\n* Strabismus\n* Ocular limitations\n* Systemic abnormalities affecting vision and ocular motility.'}, 'identificationModule': {'nctId': 'NCT05373693', 'briefTitle': 'Myopia-control Efficacy by Peripheral Defocus Lens (PDL)', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'Evaluation of Visual Performance and Myopia-control Efficacy Afforded by Bestivue Peripheral Defocus Lens (PDL)', 'orgStudyIdInfo': {'id': 'TJYYLL-2018-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The subjects are randomized to wear SV lens', 'interventionNames': ['Device: Single vision lens']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group +2D', 'description': 'The subjects are randomized to wear special designed lens with +2D Peripheral Defocus.', 'interventionNames': ['Device: +2D PDL']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group +3D', 'description': 'The subjects are randomized to wear special designed lens with +3D Peripheral Defocus.', 'interventionNames': ['Device: +3D PDL']}, {'type': 'EXPERIMENTAL', 'label': 'experimental group +4D', 'description': 'The subjects are randomized to wear special designed lens with +4D Peripheral Defocus.', 'interventionNames': ['Device: +4D PDL']}], 'interventions': [{'name': 'Single vision lens', 'type': 'DEVICE', 'description': 'Wear single vision lens', 'armGroupLabels': ['Control group']}, {'name': '+2D PDL', 'type': 'DEVICE', 'description': 'Wear Peripheral defocus lense with +2D', 'armGroupLabels': ['experimental group +2D']}, {'name': '+3D PDL', 'type': 'DEVICE', 'description': 'Wear Peripheral defocus lense with +3D', 'armGroupLabels': ['experimental group +3D']}, {'name': '+4D PDL', 'type': 'DEVICE', 'description': 'Wear Peripheral defocus lense with +4D', 'armGroupLabels': ['experimental group +4D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Lihua Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}