Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-31 @ 6:40 AM
Study NCT ID:
NCT04711395
Status:
UNKNOWN
Last Update Posted:
2021-01-15
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'photos of the anterior segment', 'timeFrame': '2021.01-2021.02', 'description': "anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils"}, {'measure': 'self-scoring of the preoperative visual quality assessment scale', 'timeFrame': '2021.01-2021.02', 'description': 'self-scoring of the preoperative Catquest-9SF visual quality assessment scale.'}], 'primaryOutcomes': [{'measure': 'Dysfunctional lens index', 'timeFrame': '2021.01-2021.02', 'description': 'iTrace ocular aberration analyzer（itracey Technologies） to measure the preoperative DLI(Dysfunctional lens index)'}], 'secondaryOutcomes': [{'measure': 'SS-OCT image of the lens', 'timeFrame': '2021.01-2021.02', 'description': 'IOL-Master 700 biometer to measure preoperative SS-OCT image of the lens'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age-related cataract', 'DLI'], 'conditions': ['Age-Related Cataract']}, 'referencesModule': {'references': [{'pmid': '27070231', 'type': 'BACKGROUND', 'citation': 'Faria-Correia F, Ramos I, Lopes B, Monteiro T, Franqueira N, Ambrosio R Jr. Comparison of Dysfunctional Lens Index and Scheimpflug Lens Densitometry in the Evaluation of Age-Related Nuclear Cataracts. J Refract Surg. 2016 Apr;32(4):244-8. doi: 10.3928/1081597X-20160209-01.'}, {'pmid': '28192585', 'type': 'BACKGROUND', 'citation': 'Faria-Correia F, Ramos I, Lopes B, Monteiro T, Franqueira N, Ambrosio R Jr. Correlations of Objective Metrics for Quantifying Dysfunctional Lens Syndrome With Visual Acuity and Phacodynamics. J Refract Surg. 2017 Feb 1;33(2):79-83. doi: 10.3928/1081597X-20161206-05.'}, {'pmid': '30822168', 'type': 'BACKGROUND', 'citation': 'Li Z, Yu L, Chen D, Chang P, Wang D, Zhao Y, Liu S, Zhao YE. Dysfunctional Lens Index Serves as a Novel Surgery Decision-Maker for Age-Related Nuclear Cataracts. Curr Eye Res. 2019 Jul;44(7):733-738. doi: 10.1080/02713683.2019.1584676. Epub 2019 Mar 1.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/30822168/', 'label': 'Dysfunctional Lens Index Serves as a Novel Surgery Decision-Maker for Age-Related Nuclear Cataracts'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27070231/', 'label': 'Comparison of Dysfunctional Lens Index and Scheimpflug Lens Densitometry in the Evaluation of Age-Related Nuclear Cataracts'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/28192585/', 'label': 'Correlations of Objective Metrics for Quantifying Dysfunctional Lens Syndrome With Visual Acuity and Phacodynamics'}]}, 'descriptionModule': {'briefSummary': "Before cataract surgery, subjects in the observation group used iTrace ocular aberration analyzer（itracey Technologies）and IOL-Master 700 biometer to measure the preoperative DLI(Dysfunctional lens index) and SS-OCT image of the lens, and The researchers used the anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils .and self-scoring of the preoperative visual quality assessment scale. Healthy subjects in the control group also need to complete the above inspections. After that, three experienced cataract specialist surgeons combined the preoperative optometry data of each subject, the photos of the LOCS III anterior segment and the Catquest-9SF questionnaire score to determine whether each subjects should undergo cataract surgery. The subjects were divided into cataract surgery group and non-surgical group. Finally, statistically study the correlation between the DLI index and the degree of lens opacity that has been collected, and use the ROC curve to calculate the DLI as the best cut-off point of DLI to distinguish whether to perform cataract surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with simple age-related cataracts and healthy patients without systemic or eye diseases attending the Eye Optometry Hospital of Wenzhou Medical University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 40 years old\n* Healthy volunteers with no history of systemic or ocular diseases\n* patients with simple age-related cataracts without other ocular diseases\n* those who can communicate with the tester at a normal level\n* those who can express their own ideas independently\n\nExclusion Criteria:\n\n* irregular corneal astigmatism\n* corneal opacity\n* corneal scars\n* corneal dystrophy\n* shallow of anterior chamber\n* retinal abnormalities\n* history of eye surgery or laser treatment\n* pupil diameter less than 4.00mm in a dark environment\n* subjects who did not cooperate well during the examination'}, 'identificationModule': {'nctId': 'NCT04711395', 'briefTitle': 'The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery', 'orgStudyIdInfo': {'id': 'YZhao'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cataract Surgery Group', 'interventionNames': ['Device: measure the preoperative DLI、 SS-OCT image of the lens,、take photos of the anterior segment and self-scoring of the preoperative visual quality assessment scale.']}, {'label': 'Non-surgical group', 'interventionNames': ['Device: measure the preoperative DLI、 SS-OCT image of the lens,、take photos of the anterior segment and self-scoring of the preoperative visual quality assessment scale.']}], 'interventions': [{'name': 'measure the preoperative DLI、 SS-OCT image of the lens,、take photos of the anterior segment and self-scoring of the preoperative visual quality assessment scale.', 'type': 'DEVICE', 'description': "subjects in the observation group and Healthy used iTrace ocular aberration analyzer（itracey Technologies）and IOL-Master 700 biometer to measure the preoperative DLI(Dysfunctional lens index) and SS-OCT image of the lens, and The researchers used the anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils .and self-scoring of the preoperative visual quality assessment scale.", 'armGroupLabels': ['Cataract Surgery Group', 'Non-surgical group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '313000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhangliang li', 'role': 'CONTACT'}], 'facility': 'Wenzhou Medical University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'zhangliang LI', 'role': 'CONTACT', 'email': 'lizhangliang0328@126.com', 'phone': '13968832833'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Dean', 'investigatorFullName': 'Yune Zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}