Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT06425432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Higher Order Aberration and Relationship With Soft Contact Lens Modulus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057108', 'term': 'Corneal Wavefront Aberration'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-13', 'size': 197197, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-20T13:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2024-05-15', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in HOA with and without contact lenses', 'timeFrame': 'Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.', 'description': 'Measure HOA with contact lenses. And then measure HOA without contact lenses.'}], 'secondaryOutcomes': [{'measure': 'Correlation between contact lens modulus and changes in HOA with and without contact lenses', 'timeFrame': 'Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.', 'description': 'Evaluate correlation between the lens modulus and changes in HOA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact Lens', 'Higher order aberration', 'Modulus'], 'conditions': ['Corneal Wavefront Aberration']}, 'descriptionModule': {'briefSummary': 'Higher order aberrations are imperfects in the eye that affect the quality of image projected onto the retina. Soft contact lenses are made of different materials with different stiffness. This study looks to see if the soft contact lens material affects the amount of higher order aberrations in an eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (\\>18 years old) who are wearing single-vision soft contact lenses will be recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Adults \\> 18 years old regardless of gender, race, or ethnicity\n* Habitual single vision soft CL wearer for at least 1 week in any modality.\n\nExclusion Criteria:\n\n* Multifocal soft CL wear\n* GP or ortho K wear in the last 3 months.\n* Active eye infections and inflammations.\n* Current use of ocular medication.'}, 'identificationModule': {'nctId': 'NCT06425432', 'briefTitle': 'Higher Order Aberration and Relationship With Soft Contact Lens Modulus', 'organization': {'class': 'OTHER', 'fullName': 'Southern College of Optometry'}, 'officialTitle': 'Higher Order Aberration and Relationship With Soft Contact Lens Modulus', 'orgStudyIdInfo': {'id': '6733'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CL first', 'description': 'Subject will present wearing habitual contact lenses for the aberrometry measurement. They will then remove their contact lenses and measurement repeated uncorrected.', 'interventionNames': ['Device: OVITZ xwave aberrometer']}, {'label': 'Glasses first', 'description': 'Subjects will refrain from contact lens wear on day of the visit. Initial aberrometry measurement will be performed uncorrected. They will be then asked to insert their contact lenses and aberrometry measurements repeated.', 'interventionNames': ['Device: OVITZ xwave aberrometer']}], 'interventions': [{'name': 'OVITZ xwave aberrometer', 'type': 'DEVICE', 'description': 'wavefront aberrometer', 'armGroupLabels': ['CL first', 'Glasses first']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yueren Wang, OD', 'role': 'CONTACT', 'email': 'ywang@sco.edu', 'phone': '901-252-3691'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months - 3 years after publication', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern College of Optometry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yueren Wang, OD', 'investigatorAffiliation': 'Southern College of Optometry'}}}}