Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT07294404
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2025-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Relative Refractive Power of Orthokeratology Lenses
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': 53}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2025-12-07', 'studyFirstSubmitQcDate': '2025-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in axial length growth(ALG)', 'timeFrame': 'Change from baseline in axial length at 12 months', 'description': 'Axial length will be measured using an ocular biometer (AL-Scan, NIDEK, Japan). Axial length growth (ALG) will be defined as the difference between the 1-year measurement and baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in Relative Peripheral Retinal Refraction', 'timeFrame': 'Baseline (pre-lens wear), 1 month, 6 months, and 12 months after orthokeratology lens wear.', 'description': 'Retinal refractive power will be measured using multispectral retinal refractive topography. Relative peripheral retinal refraction will be calculated as the difference between peripheral and central retinal refractive power. Changes from pre- to post-orthokeratology lens wear will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia', 'Myopia; Refractive Error']}, 'descriptionModule': {'briefSummary': 'Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina.\n\nThis study aims to evaluate changes in relative peripheral retinal refraction before and after OK lens wear using wide-field multispectral retinal refractive topography. The study will also investigate the relationship between these retinal refractive changes and the effectiveness of OK in controlling axial elongation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 8 to 15 years with myopia who are eligible for and fitted with orthokeratology lenses. Participants must demonstrate the ability to maintain adequate compliance with lens wear and follow-up requirements.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8 to 15 years old\n* myopia of -4.00D or lower,\n* regular astigmatism ≤1.50D and non-regular astigmatism ≤1.00D\n* intraocular pressure ≤21mmHg\n* understand the purpose of the study and have good hygiene and regular follow-up\n\nExclusion Criteria:\n\n* unilateral\n* immunocompromised subjects with systemic diseases (such as acute or chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.)\n* complicated with other eye diseases that affect OK lens wearing, such as dacryocystitis, blepharitis and other inflammation, glaucoma, etc.\n* BCVA more than 1.0\n* children with corneal curvature less than 40.00D or higher than 46.00D.'}, 'identificationModule': {'nctId': 'NCT07294404', 'briefTitle': 'Peripheral Relative Refractive Power of Orthokeratology Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'Effectiveness of Orthokeratology and Peripheral Retinal Refraction Changes', 'orgStudyIdInfo': {'id': 'OK RPR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'orthokeratology', 'type': 'DEVICE', 'description': 'All participants will be fitted with orthokeratology lenses of the same design. The primary objective is to assess changes in relative peripheral retinal refraction before and after lens wear.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Xiaoyan Yang', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}