Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT03728218
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Outcomes for Toric Efficacy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003261', 'term': 'Contact Lenses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-11-01', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance low contrast visual acuity', 'timeFrame': 'Up to two hours', 'description': 'Monocular and binocular logMAR visual acuity'}], 'secondaryOutcomes': [{'measure': 'Residual refractive error measured monocularly by cyclopleged auto-refraction', 'timeFrame': 'Up to two hours', 'description': 'Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism', 'Myopia']}, 'referencesModule': {'references': [{'pmid': '14972717', 'type': 'BACKGROUND', 'citation': 'Cheung SW, Cho P. Subjective and objective assessments of the effect of orthokeratology--a cross-sectional study. Curr Eye Res. 2004 Feb;28(2):121-7. doi: 10.1076/ceyr.28.2.121.26236.'}, {'pmid': '23838771', 'type': 'BACKGROUND', 'citation': 'Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013 Aug 27;54(8):5761-70. doi: 10.1167/iovs.13-11904.'}, {'pmid': '26283026', 'type': 'BACKGROUND', 'citation': 'Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Suzaki A. The effects of entrance pupil centration and coma aberrations on myopic progression following orthokeratology. Clin Exp Optom. 2015 Nov;98(6):534-40. doi: 10.1111/cxo.12297. Epub 2015 Aug 17.'}, {'pmid': '25190657', 'type': 'BACKGROUND', 'citation': 'Benavente-Perez A, Nour A, Troilo D. Axial eye growth and refractive error development can be modified by exposing the peripheral retina to relative myopic or hyperopic defocus. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6765-73. doi: 10.1167/iovs.14-14524.'}, {'pmid': '12912692', 'type': 'BACKGROUND', 'citation': 'Kleinstein RN, Jones LA, Hullett S, Kwon S, Lee RJ, Friedman NE, Manny RE, Mutti DO, Yu JA, Zadnik K; Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study Group. Refractive error and ethnicity in children. Arch Ophthalmol. 2003 Aug;121(8):1141-7. doi: 10.1001/archopht.121.8.1141.'}, {'pmid': '24076542', 'type': 'BACKGROUND', 'citation': 'Berntsen DA, Kramer CE. Peripheral defocus with spherical and multifocal soft contact lenses. Optom Vis Sci. 2013 Nov;90(11):1215-24. doi: 10.1097/OPX.0000000000000066.'}, {'pmid': '18804868', 'type': 'BACKGROUND', 'citation': 'Van Meter WS, Musch DC, Jacobs DS, Kaufman SC, Reinhart WJ, Udell IJ; American Academy of Ophthalmology. Safety of overnight orthokeratology for myopia: a report by the American Academy of Ophthalmology. Ophthalmology. 2008 Dec;115(12):2301-2313.e1. doi: 10.1016/j.ophtha.2008.06.034. Epub 2008 Sep 20.'}, {'pmid': '26016072', 'type': 'BACKGROUND', 'citation': 'Luo M, Ma S, Liang N. Clinical efficacy of toric orthokeratology in myopic adolescent with moderate to high astigmatism. Eye Sci. 2014 Dec;29(4):209-13, 218.'}, {'pmid': '24003088', 'type': 'BACKGROUND', 'citation': 'Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE study). Invest Ophthalmol Vis Sci. 2013 Oct 3;54(10):6510-7. doi: 10.1167/iovs.13-12527.'}, {'pmid': '30214344', 'type': 'BACKGROUND', 'citation': 'Zimmerman AB, Nixon AD, Rueff EM. Contact lens associated microbial keratitis: practical considerations for the optometrist. Clin Optom (Auckl). 2016 Jan 29;8:1-12. doi: 10.2147/OPTO.S66424. eCollection 2016.'}, {'pmid': '23892491', 'type': 'BACKGROUND', 'citation': 'Bullimore MA, Sinnott LT, Jones-Jordan LA. The risk of microbial keratitis with overnight corneal reshaping lenses. Optom Vis Sci. 2013 Sep;90(9):937-44. doi: 10.1097/OPX.0b013e31829cac92.'}, {'pmid': '36705710', 'type': 'DERIVED', 'citation': 'Tomiyama ES, Richdale K. Clinical Outcomes of a Randomized Trial with Contact Lenses for Astigmatic Myopia Management. Optom Vis Sci. 2023 Jan 1;100(1):9-16. doi: 10.1097/OPX.0000000000001969. Epub 2022 Dec 6.'}, {'pmid': '32568927', 'type': 'DERIVED', 'citation': 'Tomiyama ES, Logan AK, Richdale K. Corneal Elevation, Power, and Astigmatism to Assess Toric Orthokeratology Lenses in Moderate-to-High Astigmats. Eye Contact Lens. 2021 Feb 1;47(2):86-90. doi: 10.1097/ICL.0000000000000721.'}]}, 'descriptionModule': {'briefSummary': 'This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 39 years of age (inclusive)\n* Able to read and understand the study informed consent\n* Plano to -5.00 D (inclusive) vertex corrected sphere power in each eye\n* 1.25 to -3.50 D (inclusive) vertex corrected astigmatism in each eye\n* Best corrected acuity of 20/25 or better in each eye\n* No history of ocular pathology or surgery\n* No significant binocular vision or accommodation abnormality (i.e. strabismus, amblyopia)\n* No gas permeable lens wear for at least 1 month\n* No systemic or ocular contraindications for contact lens wear\n* Not pregnant/lactating (by self-report)\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits.\n* Pregnant/lactating women (by self-report)'}, 'identificationModule': {'nctId': 'NCT03728218', 'acronym': 'VOTE', 'briefTitle': 'Visual Outcomes for Toric Efficacy Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Visual Outcomes for Toric Efficacy Study', 'orgStudyIdInfo': {'id': 'STUDY00001070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orthokeratology Contact lenses', 'interventionNames': ['Device: Contact lenses (Orthokeratology)']}, {'type': 'EXPERIMENTAL', 'label': 'Soft Multifocal Contact lenses', 'interventionNames': ['Device: Contact lenses (Soft Multifocal)']}], 'interventions': [{'name': 'Contact lenses (Orthokeratology)', 'type': 'DEVICE', 'description': 'Contact lenses', 'armGroupLabels': ['Orthokeratology Contact lenses']}, {'name': 'Contact lenses (Soft Multifocal)', 'type': 'DEVICE', 'description': 'Contact lenses', 'armGroupLabels': ['Soft Multifocal Contact lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kathryn Richdale', 'investigatorAffiliation': 'University of Houston'}}}}