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

NCT06743594 | Recruiting

• 1 other identifier: 202401405A3
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cataract; Myopia

Keywords

antioxidants

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (5)

• BCVA

  Before surgery

• UCVA at 1 week

  1 week after surgery

• UCVA at 1 month

  1 month after surgery

• UCVA at 2 months

  2 months after surgery

• UCVA at 3 months

  3 months after surgery

Study Arms (4)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• at least 20 years old
• corneal refractive surgery or cataract surgery patients

You may not qualify if:

• patients with eye infections
• presence of severe retinal disease
• presence of severe eye injury or severe ptosis

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Taipei Nobel Eye Clinic: collaborator

Study Sites (2)

Taipei Nobel Eye Clinic

Taipei, 100, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 31490199 BACKGROUND

• 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.

  PMID: 37026241 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

tear, aqueous humor

MeSH Terms

Conditions

Cataract; Myopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Central Study Contacts

Hung-Chi Chen, PhD

CONTACT

+886-975365859; mr3756@cgmh.org.tw

Chia-Yi Li, MD

CONTACT

+886-2-27400058; ao6u.3msn@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: March 14, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2024-12

Locations

TW (2)