Measurement of Antioxidant Activity and Oxidative Stress in Patients Undergoing Ophthalmic Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cataract, Myopia. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Laser Species and Ocular Antioxidant Activity on Postoperative Inflammation, Oxidative Stress and Visual Prognosis in Patients Undergoing Ophthalmic Surgery - a Comparative Study.
Overview
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.
Detailed description
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.
Primary outcome measures
- TAC in tears at 1 week [Time frame: Before the operation and 1 week after surgery.]
- TAC in tears at 1 month [Time frame: Before the operation and 1 month after surgery.]
- TAC in tears at 2 months [Time frame: Before the operation and 2 months after surgery.]
- TAC in tears at 3 months [Time frame: Before the operation and 3 months after surgery.]
- AA in tears at 1 week [Time frame: Before the operation and 1 week after surgery.]
- AA in tears at 1 month [Time frame: Before the operation and 1 month after surgery.]
- AA in tears at 2 months [Time frame: Before the operation and 2 months after surgery.]
- AA in tears at 3 months [Time frame: Before the operation and 3 months after surgery.]
- ROS in tears at 1 week [Time frame: Before the operation and 1 week after surgery.]
- ROS in tears at 1 month [Time frame: Before the operation and 1 month after surgery.]
Secondary outcome measures (5)
- BCVA [Time frame: Before surgery]
- UCVA at 1 week [Time frame: 1 week after surgery]
- UCVA at 1 month [Time frame: 1 month after surgery]
- UCVA at 2 months [Time frame: 2 months after surgery]
- UCVA at 3 months [Time frame: 3 months after surgery]
Eligibility criteria
Inclusion criteria
- at least 20 years old
- corneal refractive surgery or cataract surgery patients
Exclusion criteria
- patients with eye infections
- presence of severe retinal disease
- presence of severe eye injury or severe ptosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 2 centers
- Taipei Nobel Eye Clinic — Taipei
- Chang Gung Memorial Hospital — Taoyuan
Publications
- 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 24187660
- 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 32477165
- 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 35204279
- 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 31498249
- 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 34656060
- 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 24227802
- 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 28834388
- 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 28549842
Identifiers
NCT: NCT06743594 · 202401405A3