Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-03-11 @ 9:56 AM
Study NCT ID:
NCT00978692
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2009-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toric Orthokeratology - Slowing Eye Elongation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2009-09-16', 'studyFirstSubmitQcDate': '2009-09-16', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the eyeball elongation in children wearing ortho-k lenses', 'timeFrame': 'Before lens wear, 6, 12,18, 24 months after lens wear'}], 'secondaryOutcomes': [{'measure': 'To determine the posterior corneal curvatures, topographic corneal thickness, corneal volume, corneal hysteresis and corneal resistance factor in a group of children and compare these parameters with the ortho-k children', 'timeFrame': 'Before lens wear, 6, 12,18, 24 months after lens wear'}, {'measure': 'To investigative the efficacy of toric orthokeratology for correcting astigmatism and myopia', 'timeFrame': 'Before lens wear, 6, 12,18, 24 months after lens wear'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myopia', 'Astigmatism', 'Orthokeratology', 'Corneal thickness', 'Corneal curvatures', 'Corneal biomechanics'], 'conditions': ['Myopia', 'Astigmatism']}, 'referencesModule': {'references': [{'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': '22561203', 'type': 'BACKGROUND', 'citation': 'Chen CC, Cheung SW, Cho P. Toric orthokeratology for highly astigmatic children. Optom Vis Sci. 2012 Jun;89(6):849-55. doi: 10.1097/OPX.0b013e318257c20f.'}, {'pmid': '21895768', 'type': 'BACKGROUND', 'citation': 'Chen C, Cho P. Toric orthokeratology for high myopic and astigmatic subjects for myopic control. Clin Exp Optom. 2012 Jan;95(1):103-8. doi: 10.1111/j.1444-0938.2011.00616.x. Epub 2011 Sep 5. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study are to investigate the effects of ortho-k for astigmatic and myopic reduction and myopic control in children, and the long term effects on corneal curvatures and biomechanics.', 'detailedDescription': 'Ortho-k has been shown to be effective in correcting low myopia but relatively ineffective for astigmatism, using spherical reverse geometry lens designs. Toric ortho-k lenses have been introduced in recent years but the efficacy for astigmatic reduction and for myopic control in children have not been confirmed. The mechanism of myopic reduction in ortho-k cannot be fully explained by changes to the anterior corneal curvatures. It is therefore possible that other corneal parameters such as posterior corneal curvature and corneal biomechanics may contribute to the mechanism.\n\nThe current study aims at investigating the efficacy of toric ortho-k lenses for correcting myopic astigmatism and for retarding myopic progression in children compared to children wearing single-vision spectacles. Long term changes to other corneal parameters such as posterior cornea curvatures, topographical corneal thickness, corneal hysteresis, corneal resistance factor, with and without ortho-k lens wear will also be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myopia (refractive sphere): more than -0.50DS to -5.00DS\n* Astigmatism: with-the-rule astigmatism more than -1.25DC\n* Anisometropia: ≤ 1.50D in both refractive sphere\n* Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes\n* Availability for follow-up for at least 2 years\n\nExclusion Criteria:\n\n* Strabismus at distance or near\n* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex\n* Prior experience with the use of rigid lenses (including orthokeratology)\n* Prior experience with myopia control treatment (e.g. refractive therapy or progressive spectacles)\n* Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)\n* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)'}, 'identificationModule': {'nctId': 'NCT00978692', 'acronym': 'TO-SEE', 'briefTitle': 'Toric Orthokeratology - Slowing Eye Elongation', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Toric Orthokeratology for Slowing Eye Elongation in Astigmatic Children', 'orgStudyIdInfo': {'id': 'H-ZG30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Toric orthokeratology lenses', 'description': 'Children wearing toric ortho-k lenses at night for correcting astigmatism and myopia will be the study group', 'interventionNames': ['Device: Toric Orthokeratology lenses']}, {'type': 'OTHER', 'label': 'Single-vision spectacles', 'description': 'Children wearing single-vision spectacles in the daytime for correcting the refractive error will be serve as control group', 'interventionNames': ['Device: Single-vision spectacles']}], 'interventions': [{'name': 'Toric Orthokeratology lenses', 'type': 'DEVICE', 'otherNames': ['corneal reshaping therapy'], 'description': 'Children wearing toric orthokeratology at night for correcting astigmatism and myopia will be the study group', 'armGroupLabels': ['Toric orthokeratology lenses']}, {'name': 'Single-vision spectacles', 'type': 'DEVICE', 'otherNames': ['glasses'], 'description': 'Children wearing single-vision spectacles in the daytime for correcting the refractive errors will serve as the control group', 'armGroupLabels': ['Single-vision spectacles']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong SAR', 'country': 'China', 'facility': 'School of Optometry, The Hong KOng Polytechnic University'}], 'overallOfficials': [{'name': 'Pauline Cho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Menicon Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pauline Cho', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}