Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT05818033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-23
First Post:
2023-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control
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': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 760}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of spherical equivalent refraction (SER) at one year', 'timeFrame': '1 year', 'description': 'The difference of SER at one year from baseline. SER will be measured after cycloplegia'}], 'secondaryOutcomes': [{'measure': 'Changes of axial length (AL) at one year', 'timeFrame': '1 year', 'description': 'The difference of AL at one year from baseline.'}, {'measure': 'Change of anterior chamber depth (ACD) at one year', 'timeFrame': '1 year', 'description': 'The difference of ACD at one year from baseline.'}, {'measure': 'Change of lens thickness (LT) at one year', 'timeFrame': '1 year', 'description': 'The difference of LT at one year from baseline.'}, {'measure': 'Change of corneal curvature (CR) at one year', 'timeFrame': '1 year', 'description': 'The difference of CR at one year from baseline.'}, {'measure': 'Best corrected visual acuity at one year', 'timeFrame': '1 year', 'description': 'Best corrected visual acuity'}, {'measure': 'Binocular visual function at one year', 'timeFrame': '1 year', 'description': 'Binocular visual function'}, {'measure': 'Choroidal thickness at one year', 'timeFrame': '1 year', 'description': 'The difference of Choroidal thickness at one year from baseline.'}, {'measure': 'Visual scale score at 1 year', 'timeFrame': '1 year', 'description': 'Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2)'}, {'measure': 'Time length of wearing spectcales at one year', 'timeFrame': '1 year', 'description': 'Time length of wearing spectcales collected every half year'}, {'measure': 'Safty of wearing the spectacle lens', 'timeFrame': '1 year', 'description': 'Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations through symptoms and signs, intraocular pressure#slit lamp and ocular fundus checks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myopia control'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '28746982', 'type': 'BACKGROUND', 'citation': 'Irving EL, Yakobchuk-Stanger C. Myopia progression control lens reverses induced myopia in chicks. Ophthalmic Physiol Opt. 2017 Sep;37(5):576-584. doi: 10.1111/opo.12400. Epub 2017 Jul 26.'}, {'pmid': '26875007', 'type': 'RESULT', 'citation': 'Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.'}, {'pmid': '30342076', 'type': 'RESULT', 'citation': 'Naidoo KS, Fricke TR, Frick KD, Jong M, Naduvilath TJ, Resnikoff S, Sankaridurg P. Potential Lost Productivity Resulting from the Global Burden of Myopia: Systematic Review, Meta-analysis, and Modeling. Ophthalmology. 2019 Mar;126(3):338-346. doi: 10.1016/j.ophtha.2018.10.029. Epub 2018 Oct 17.'}, {'pmid': '30817829', 'type': 'RESULT', 'citation': 'Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, Sankaridurg P, Saw SM, Trier K, Walline JJ, Wu PC, Wolffsohn JS. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M106-M131. doi: 10.1167/iovs.18-25958.'}, {'pmid': '33811039', 'type': 'RESULT', 'citation': 'Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.'}, {'pmid': '10343811', 'type': 'RESULT', 'citation': 'Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6.'}, {'pmid': '3603011', 'type': 'RESULT', 'citation': 'Wallman J, Gottlieb MD, Rajaram V, Fugate-Wentzek LA. Local retinal regions control local eye growth and myopia. Science. 1987 Jul 3;237(4810):73-7. doi: 10.1126/science.3603011.'}, {'pmid': '18055781', 'type': 'RESULT', 'citation': 'Tse DY, Lam CS, Guggenheim JA, Lam C, Li KK, Liu Q, To CH. Simultaneous defocus integration during refractive development. Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5352-9. doi: 10.1167/iovs.07-0383.'}, {'pmid': '27479812', 'type': 'RESULT', 'citation': 'Arumugam B, Hung LF, To CH, Sankaridurg P, Smith EL III. The Effects of the Relative Strength of Simultaneous Competing Defocus Signals on Emmetropization in Infant Rhesus Monkeys. Invest Ophthalmol Vis Sci. 2016 Aug 1;57(10):3949-60. doi: 10.1167/iovs.16-19704.'}, {'pmid': '21911586', 'type': 'RESULT', 'citation': 'Tse DY, To CH. Graded competing regional myopic and hyperopic defocus produce summated emmetropization set points in chick. Invest Ophthalmol Vis Sci. 2011 Oct 17;52(11):8056-62. doi: 10.1167/iovs.10-5207.'}, {'pmid': '23471891', 'type': 'RESULT', 'citation': 'Woods J, Guthrie SE, Keir N, Dillehay S, Tyson M, Griffin R, Choh V, Fonn D, Jones L, Irving E. Inhibition of defocus-induced myopia in chickens. Invest Ophthalmol Vis Sci. 2013 Apr 12;54(4):2662-8. doi: 10.1167/iovs.12-10742.'}]}, 'descriptionModule': {'briefSummary': 'China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, The researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 12 to 17 years;\n* Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;\n* Best-corrected visual acuity of equal or better than 0.00 LogMAR (\\>= 1.0 as Snellen).\n* The intraocular pressure of 10 to 21mmHg.\n* Volunteer to participate in this clinical trial with signature of the informed consent form.\n\nExclusion Criteria:\n\n* History of eye injury or intraocular surgery;\n* Clinically abnormal slit-lamp findings;\n* Abnormal fundus examination;\n* Ocular disease, such as uveitis and other inflammatory diseases,glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;\n* Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);\n* Participation of the drug clinical trial within three month and the device clinical trial within one month;\n* Only one eye meets the inclusion criteria;\n* Unable to have regular follow-up;\n* Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc."}, 'identificationModule': {'nctId': 'NCT05818033', 'briefTitle': 'Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'Safety and Effectiveness of CARE1.02 Spectacle Lens Versus Single-vision Spectacle Lens in Myopia Control: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2023KYPJ005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'CARE1.02', 'interventionNames': ['Device: CARE1.02']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Single-vision spectacle lens', 'interventionNames': ['Device: Single-vision spectacle lens']}], 'interventions': [{'name': 'CARE1.02', 'type': 'DEVICE', 'description': 'Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.', 'armGroupLabels': ['Intervention group']}, {'name': 'Single-vision spectacle lens', 'type': 'DEVICE', 'description': 'Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The researchs will share the IPD as request in future.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}