Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT05658718
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2022-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Influencing Nocturnal Symptoms After Refractive Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2022-11-20', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of diopter under bright and dark pupils.', 'timeFrame': 'Preoperative', 'description': 'Use OPDScan Ⅲ to measure the parameters of both eyes'}, {'measure': 'Changes of diopter under bright and dark pupils.', 'timeFrame': 'Day 7', 'description': 'Use OPDScan Ⅲ to measure the parameters of both eyes.'}, {'measure': 'Changes of diopter under bright and dark pupils.', 'timeFrame': 'Month 1', 'description': 'Use OPDScan Ⅲ to measure the parameters of both eyes.'}, {'measure': 'Changes of diopter under bright and dark pupils.', 'timeFrame': 'Month 3', 'description': 'Use OPDScan Ⅲ to measure the parameters of both eyes.'}, {'measure': 'Changes of diopter under bright and dark pupils.', 'timeFrame': 'Month 6', 'description': 'Use OPDScan Ⅲ to measure the parameters of both eyes.'}, {'measure': 'objective visual quality.', 'timeFrame': 'Day 7', 'description': 'Measurement of objective visual quality using Binopotometer.'}, {'measure': 'objective visual quality.', 'timeFrame': 'Month 1', 'description': 'Measurement of objective visual quality using Binopotometer and NIDEK Automatic computerized optometry instrument（ARK-1s).'}, {'measure': 'objective visual quality.', 'timeFrame': 'Month 3', 'description': 'Measurement of objective visual quality using Binopotometer.'}, {'measure': 'objective visual quality.', 'timeFrame': 'Month 6', 'description': 'Measurement of objective visual quality using Binopotometer.'}, {'measure': 'subjective visual quality', 'timeFrame': 'Day 7', 'description': "Using visual quality questionnaire to evaluate patients' subjective visual quality."}, {'measure': 'subjective visual quality', 'timeFrame': 'Month 1', 'description': "Using visual quality questionnaire to evaluate patients' subjective visual quality."}, {'measure': 'subjective visual quality', 'timeFrame': 'Month 3', 'description': "Using visual quality questionnaire to evaluate patients' subjective visual quality."}, {'measure': 'subjective visual quality', 'timeFrame': 'Month 6', 'description': "Using visual quality questionnaire to evaluate patients' subjective visual quality."}, {'measure': 'ICL Vault', 'timeFrame': 'Day 7', 'description': 'Measuring ICL vault with Pentacam'}, {'measure': 'ICL Vault', 'timeFrame': 'Month 1', 'description': 'Measuring ICL vault with Pentacam'}, {'measure': 'ICL Vault', 'timeFrame': 'Month 3', 'description': 'Measuring ICL vault with Pentacam'}, {'measure': 'ICL Vault', 'timeFrame': 'Month 6', 'description': 'Measuring ICL vault with Pentacam'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['refractive surgery', 'glare', 'pupil', 'visual quality', 'Aberrations'], 'conditions': ['Refractive Surgery', 'Visual Quality']}, 'referencesModule': {'references': [{'pmid': '38350161', 'type': 'DERIVED', 'citation': 'Xiong J, Xu J, Zhou M, Liu J, Wang Q, Yin X, Deng Y, Luo X, Wang N, Gui F, Yu K, Liu J, Zhu Z, Cheng C, Yu Y. Mesopic pupil indices as potential risk factors for glare disability after intraocular implantable collamer lens implantation: prospective study. J Cataract Refract Surg. 2024 Jun 1;50(6):565-571. doi: 10.1097/j.jcrs.0000000000001420.'}]}, 'descriptionModule': {'briefSummary': 'By comparing the parameters of the two groups of patients with glare at night after refractive surgery and those without glare at night, the influence of preoperative related parameters on postoperative glare was analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People undergoing refractive surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria：\n\n* Age ≥18 years old；\n* Stable diopter (diopter change less than 0.5D in the past 2 years);\n* Best corrected distance visual acuity (CDVA) of 1.0 or better；\n* Anterior chamber depth (ACD) ≥2.8 mm;\n* Corneal endothelial cell density (ECD) ≥ 2 000 cells/mm.\n\nExclusion criteria:\n\n* History of ocular trauma or surgery;\n* Suspected keratoconus;\n* Previous history of other ocular diseases such as corneal inflammation or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataract, amblyopia, etc.;\n* History of severe dry eye；\n* Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; or severe mental disorders, such as anxiety and depression.'}, 'identificationModule': {'nctId': 'NCT05658718', 'briefTitle': 'Factors Influencing Nocturnal Symptoms After Refractive Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Nanchang University'}, 'officialTitle': 'Effects of Different Pupil Size Under Light and Dark Conditions on Nighttime Symptoms After Refractive Surgery.', 'orgStudyIdInfo': {'id': '[2021] No. (113).'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'glare group.', 'description': 'Patients subjectively complained about glare and Binoptometer examination showed poor visual quality in dark environments, and they were classified as the glare group.', 'interventionNames': ['Procedure: refractive surgery']}, {'label': 'non-glare group', 'description': 'The patients did not complain of glare and the Binoptometer examination showed good visual quality in a dark environment, and they were classified as the non-glare group.', 'interventionNames': ['Procedure: refractive surgery']}], 'interventions': [{'name': 'refractive surgery', 'type': 'PROCEDURE', 'description': 'refractive surgery', 'armGroupLabels': ['glare group.', 'non-glare group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University', 'investigatorFullName': 'Yifeng Yu', 'investigatorAffiliation': 'Second Affiliated Hospital of Nanchang University'}}}}