Measurement of Antioxidant Activity and Oxidative Stress in Patients Undergoing Ophthalmic Surgery.

Effects of Laser Species and Ocular Antioxidant Activity on Postoperative Inflammation, Oxidative Stress and Visual Prognosis in Patients Undergoing Ophthalmic Surgery - a Comparative Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Myopia

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Hung-Chi Chen, PhD; Phone Number: +886-975365859; Email: mr3756@cgmh.org.tw
• Study Contact Backup: Name: Chia-Yi Li, MD; Phone Number: 556 +886-2-27400058; Email: ao6u.3msn@hotmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • Taipei Nobel Eye Clinic
    • Contact: Chia-Yi Li, MD; Phone Number: 556 +886-2-27400058; Email: ao6u.3msn@hotmail.com
  • Taoyuan District, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Hung-Chi Chen, PhD; Phone Number: +886-975365859; Email: mr3756@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study included patients with the following conditions: (1) at least 20 years old, (2) expected to undergo corneal refractive surgery or cataract surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
LASIK; Femtosecond-LASIK in myopia
KLEx; Kerato-lenticule Extraction in myopia
Traditional Cataract Surgery; Cataract Surgery with Phacoemulsification
Laser-Assisted Cataract Surgery; Cataract Surgery with LenSx Femtosecond Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAC in tears at 1 week	Change of Total Antioxidant Capacity (TAC) from Baseline to 1 week after surgery.	Before the operation and 1 week after surgery.
TAC in tears at 1 month	Change of Total Antioxidant Capacity (TAC) from Baseline to 1 month after surgery.	Before the operation and 1 month after surgery.
TAC in tears at 2 months	Change of Total Antioxidant Capacity (TAC) from Baseline to 2 months after surgery.	Before the operation and 2 months after surgery.
TAC in tears at 3 months	Change of Total Antioxidant Capacity (TAC) from Baseline to 3 months after surgery.	Before the operation and 3 months after surgery.
AA in tears at 1 week	Change of Ascorbic Acid (AA) from Baseline to 1 week after surgery.	Before the operation and 1 week after surgery.
AA in tears at 1 month	Change of Ascorbic Acid (AA) from Baseline to 1 month after surgery.	Before the operation and 1 month after surgery.
AA in tears at 2 months	Change of Ascorbic Acid (AA) from Baseline to 2 months after surgery.	Before the operation and 2 months after surgery.
AA in tears at 3 months	Change of Ascorbic Acid (AA) from Baseline to 3 months after surgery.	Before the operation and 3 months after surgery.
ROS in tears at 1 week	Change of Reactive Oxygen Species (ROS) from Baseline to 1 week after surgery.	Before the operation and 1 week after surgery.
ROS in tears at 1 month	Change of Reactive Oxygen Species (ROS) from Baseline to 1 month after surgery.	Before the operation and 1 month after surgery.
ROS in tears at 2 months	Change of Reactive Oxygen Species (ROS) from Baseline to 2 moths after surgery.	Before the operation and 2 months after surgery.
ROS in tears at 3 months	Change of Reactive Oxygen Species (ROS) from Baseline to 3 months after surgery.	Before the operation and 3 months after surgery.
TAC in aqueous humor at the next day	Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery	Before the operation and one day after surgery.
AA in aqueous humor at the next day	Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery	Before the operation and one day after surgery.
ROS in aqueous humor at the next day	Change of Reactive Oxygen Species (ROS) in aqueous humor from Baseline to one day after surgery	Before the operation and one day after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA	Examination of best corrected visual acuity (BCVA)	Before surgery
UCVA at 1 week	Examination of uncorrected visual acuity (UCVA)	1 week after surgery
UCVA at 1 month	Examination of uncorrected visual acuity (UCVA)	1 month after surgery
UCVA at 2 months	Examination of uncorrected visual acuity (UCVA)	2 months after surgery
UCVA at 3 months	Examination of uncorrected visual acuity (UCVA)	3 months after surgery

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Taipei Nobel Eye Clinic

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: antioxidants
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Myopia; Cataract
• Other Study ID Numbers: 202401405A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No