Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT05956704
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2023-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Different Design of Orthokeratology
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-07-14', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in axial length', 'timeFrame': 'The change of baseline and 1years', 'description': 'Axial length was measured with a biometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age is greater than 8 years and less than 18 years\n* The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.\n* Be able to complete 12 months of follow-up\n* They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians\n\nExclusion Criteria:\n\n* One eye met the inclusion criteria\n* Patients with systemic diseases causing immunocompromised or affecting orthokeratology\n* There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc\n* Abnormal cornea\n* Previous corneal surgery or corneal trauma history\n* Active keratitis (e.g., corneal infection)\n* Patients with best corrected distance visual acuity of less than 5.0\n* Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D\n* Patients with refractive instability\n* Patients with overt strabismus\n* The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses\n* Patients with dry eye are not suitable for orthokeratology\n* Patients with corneal endothelial cell density less than 2000 cells /mm2\n* Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days'}, 'identificationModule': {'nctId': 'NCT05956704', 'briefTitle': 'The Different Design of Orthokeratology', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth', 'orgStudyIdInfo': {'id': 'KY2023031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Device: Orthokeratology with aspheric wide inversion zone design in the optical zone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Device: Orthokeratology with traditional spherical design in the optical zone']}, {'type': 'NO_INTERVENTION', 'label': 'Blank control group'}], 'interventions': [{'name': 'Orthokeratology with aspheric wide inversion zone design in the optical zone', 'type': 'DEVICE', 'description': 'An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone', 'armGroupLabels': ['Experimental Group']}, {'name': 'Orthokeratology with traditional spherical design in the optical zone', 'type': 'DEVICE', 'description': 'Subjects wore the orthokeratology with traditional spherical design in the optical zone', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', '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'}}}}