Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 10:15 AM
Study NCT ID:
NCT06743594
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Antioxidant Activity and Oxidative Stress in Patients Undergoing Ophthalmic Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'tear, aqueous humor'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TAC in tears at 1 week', 'timeFrame': 'Before the operation and 1 week after surgery.', 'description': 'Change of Total Antioxidant Capacity (TAC) from Baseline to 1 week after surgery.'}, {'measure': 'TAC in tears at 1 month', 'timeFrame': 'Before the operation and 1 month after surgery.', 'description': 'Change of Total Antioxidant Capacity (TAC) from Baseline to 1 month after surgery.'}, {'measure': 'TAC in tears at 2 months', 'timeFrame': 'Before the operation and 2 months after surgery.', 'description': 'Change of Total Antioxidant Capacity (TAC) from Baseline to 2 months after surgery.'}, {'measure': 'TAC in tears at 3 months', 'timeFrame': 'Before the operation and 3 months after surgery.', 'description': 'Change of Total Antioxidant Capacity (TAC) from Baseline to 3 months after surgery.'}, {'measure': 'AA in tears at 1 week', 'timeFrame': 'Before the operation and 1 week after surgery.', 'description': 'Change of Ascorbic Acid (AA) from Baseline to 1 week after surgery.'}, {'measure': 'AA in tears at 1 month', 'timeFrame': 'Before the operation and 1 month after surgery.', 'description': 'Change of Ascorbic Acid (AA) from Baseline to 1 month after surgery.'}, {'measure': 'AA in tears at 2 months', 'timeFrame': 'Before the operation and 2 months after surgery.', 'description': 'Change of Ascorbic Acid (AA) from Baseline to 2 months after surgery.'}, {'measure': 'AA in tears at 3 months', 'timeFrame': 'Before the operation and 3 months after surgery.', 'description': 'Change of Ascorbic Acid (AA) from Baseline to 3 months after surgery.'}, {'measure': 'ROS in tears at 1 week', 'timeFrame': 'Before the operation and 1 week after surgery.', 'description': 'Change of Reactive Oxygen Species (ROS) from Baseline to 1 week after surgery.'}, {'measure': 'ROS in tears at 1 month', 'timeFrame': 'Before the operation and 1 month after surgery.', 'description': 'Change of Reactive Oxygen Species (ROS) from Baseline to 1 month after surgery.'}, {'measure': 'ROS in tears at 2 months', 'timeFrame': 'Before the operation and 2 months after surgery.', 'description': 'Change of Reactive Oxygen Species (ROS) from Baseline to 2 moths after surgery.'}, {'measure': 'ROS in tears at 3 months', 'timeFrame': 'Before the operation and 3 months after surgery.', 'description': 'Change of Reactive Oxygen Species (ROS) from Baseline to 3 months after surgery.'}, {'measure': 'TAC in aqueous humor at the next day', 'timeFrame': 'Before the operation and one day after surgery.', 'description': 'Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery'}, {'measure': 'AA in aqueous humor at the next day', 'timeFrame': 'Before the operation and one day after surgery.', 'description': 'Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery'}, {'measure': 'ROS in aqueous humor at the next day', 'timeFrame': 'Before the operation and one day after surgery.', 'description': 'Change of Reactive Oxygen Species (ROS) in aqueous humor from Baseline to one day after surgery'}], 'secondaryOutcomes': [{'measure': 'BCVA', 'timeFrame': 'Before surgery', 'description': 'Examination of best corrected visual acuity (BCVA)'}, {'measure': 'UCVA at 1 week', 'timeFrame': '1 week after surgery', 'description': 'Examination of uncorrected visual acuity (UCVA)'}, {'measure': 'UCVA at 1 month', 'timeFrame': '1 month after surgery', 'description': 'Examination of uncorrected visual acuity (UCVA)'}, {'measure': 'UCVA at 2 months', 'timeFrame': '2 months after surgery', 'description': 'Examination of uncorrected visual acuity (UCVA)'}, {'measure': 'UCVA at 3 months', 'timeFrame': '3 months after surgery', 'description': 'Examination of uncorrected visual acuity (UCVA)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antioxidants'], 'conditions': ['Cataract', 'Myopia']}, 'referencesModule': {'references': [{'pmid': '24187660', 'type': 'BACKGROUND', 'citation': 'Umapathy A, Donaldson P, Lim J. Antioxidant delivery pathways in the anterior eye. Biomed Res Int. 2013;2013:207250. doi: 10.1155/2013/207250. Epub 2013 Sep 26.'}, {'pmid': '32477165', 'type': 'BACKGROUND', 'citation': 'Merida S, Villar VM, Navea A, Desco C, Sancho-Tello M, Peris C, Bosch-Morell F. Imbalance Between Oxidative Stress and Growth Factors in Human High Myopia. Front Physiol. 2020 May 14;11:463. doi: 10.3389/fphys.2020.00463. eCollection 2020.'}, {'pmid': '35204279', 'type': 'BACKGROUND', 'citation': 'Tsao YT, Wu WC, Chen KJ, Liu CF, Hsueh YJ, Cheng CM, Chen HC. An Assessment of Cataract Severity Based on Antioxidant Status and Ascorbic Acid Levels in Aqueous Humor. Antioxidants (Basel). 2022 Feb 16;11(2):397. doi: 10.3390/antiox11020397.'}, {'pmid': '31498249', 'type': 'BACKGROUND', 'citation': 'Kato K, Miyake K, Hirano K, Kondo M. Management of Postoperative Inflammation and Dry Eye After Cataract Surgery. Cornea. 2019 Nov;38 Suppl 1:S25-S33. doi: 10.1097/ICO.0000000000002125.'}, {'pmid': '34656060', 'type': 'BACKGROUND', 'citation': 'Hsueh YJ, Meir YJ, Lai JY, Huang CC, Lu TT, Ma DH, Cheng CM, Wu WC, Chen HC. Ascorbic acid ameliorates corneal endothelial dysfunction and enhances cell proliferation via the noncanonical GLUT1-ERK axis. Biomed Pharmacother. 2021 Dec;144:112306. doi: 10.1016/j.biopha.2021.112306. Epub 2021 Oct 15.'}, {'pmid': '24227802', 'type': 'BACKGROUND', 'citation': 'Dong Z, Zhou X, Wu J, Zhang Z, Li T, Zhou Z, Zhang S, Li G. Small incision lenticule extraction (SMILE) and femtosecond laser LASIK: comparison of corneal wound healing and inflammation. Br J Ophthalmol. 2014 Feb;98(2):263-9. doi: 10.1136/bjophthalmol-2013-303415. Epub 2013 Nov 13.'}, {'pmid': '28834388', 'type': 'BACKGROUND', 'citation': 'Seen S, Tong L. Dry eye disease and oxidative stress. Acta Ophthalmol. 2018 Jun;96(4):e412-e420. doi: 10.1111/aos.13526. Epub 2017 Aug 21.'}, {'pmid': '28549842', 'type': 'BACKGROUND', 'citation': 'Vallabh NA, Romano V, Willoughby CE. Mitochondrial dysfunction and oxidative stress in corneal disease. Mitochondrion. 2017 Sep;36:103-113. doi: 10.1016/j.mito.2017.05.009. Epub 2017 May 23.'}, {'pmid': '31490199', 'type': 'BACKGROUND', 'citation': 'Wong AHY, Cheung RKY, Kua WN, Shih KC, Chan TCY, Wan KH. Dry Eyes After SMILE. Asia Pac J Ophthalmol (Phila). 2019 Sep-Oct;8(5):397-405. doi: 10.1097/01.APO.0000580136.80338.d0.'}, {'pmid': '37026241', 'type': 'BACKGROUND', 'citation': 'Nair S, Kaur M, Sharma N, Titiyal JS. Refractive surgery and dry eye - An update. Indian J Ophthalmol. 2023 Apr;71(4):1105-1114. doi: 10.4103/IJO.IJO_3406_22.'}]}, 'descriptionModule': {'briefSummary': 'This trial hypothesized that novel laser refractive surgery techniques (LASIK, KLEx) or laser-assisted cataract surgery (FLACAS) could suppress postoperative inflammation and improve recovery in patients by reducing oxidative stress generated by the surgical procedure. It is also intended to verify whether the new laser technology is necessary for clinical use in groups with low antioxidant activity through the detection of antioxidant activity in the eyes of patients.', 'detailedDescription': 'Simultaneously measure total reactive oxygen species (ROS), antioxidant capacity (TAC) and ascorbic acid (AA) in aqueous humor (cataract surgery only) or tears. All patients underwent the same examination at our institution, including uncorrected visual acuity (UCVA), intraocular pressure (IOP), as well as central corneal thickness (CCT) with pneumatic tonometer, apparent refraction with autorefractor, and corneal curvature with keratometer. The axial length (AXL), anterior chamber depth (ACD) and lens thickness (LT) were measured by optical biometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included patients with the following conditions: (1) at least 20 years old, (2) expected to undergo corneal refractive surgery or cataract surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 20 years old\n* corneal refractive surgery or cataract surgery patients\n\nExclusion Criteria:\n\n* patients with eye infections\n* presence of severe retinal disease\n* presence of severe eye injury or severe ptosis'}, 'identificationModule': {'nctId': 'NCT06743594', 'briefTitle': 'Measurement of Antioxidant Activity and Oxidative Stress in Patients Undergoing Ophthalmic Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Effects of Laser Species and Ocular Antioxidant Activity on Postoperative Inflammation, Oxidative Stress and Visual Prognosis in Patients Undergoing Ophthalmic Surgery - a Comparative Study.', 'orgStudyIdInfo': {'id': '202401405A3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LASIK', 'description': 'Femtosecond-LASIK in myopia'}, {'label': 'KLEx', 'description': 'Kerato-lenticule Extraction in myopia'}, {'label': 'Traditional Cataract Surgery', 'description': 'Cataract Surgery with Phacoemulsification'}, {'label': 'Laser-Assisted Cataract Surgery', 'description': 'Cataract Surgery with LenSx Femtosecond Laser'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chia-Yi Li, MD', 'role': 'CONTACT', 'email': 'ao6u.3msn@hotmail.com', 'phone': '+886-2-27400058', 'phoneExt': '556'}], 'facility': 'Taipei Nobel Eye Clinic', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hung-Chi Chen, PhD', 'role': 'CONTACT', 'email': 'mr3756@cgmh.org.tw', 'phone': '+886-975365859'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Hung-Chi Chen, PhD', 'role': 'CONTACT', 'email': 'mr3756@cgmh.org.tw', 'phone': '+886-975365859'}, {'name': 'Chia-Yi Li, MD', 'role': 'CONTACT', 'email': 'ao6u.3msn@hotmail.com', 'phone': '+886-2-27400058', 'phoneExt': '556'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taipei Nobel Eye Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}