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

NCT ID: NCT06743594

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-14

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Cataract Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LASIK

Femtosecond-LASIK in myopia

No interventions assigned to this group

KLEx

Kerato-lenticule Extraction in myopia

No interventions assigned to this group

Traditional Cataract Surgery

Cataract Surgery with Phacoemulsification

No interventions assigned to this group

Laser-Assisted Cataract Surgery

Cataract Surgery with LenSx Femtosecond Laser

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Nobel Eye Clinic

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taipei Nobel Eye Clinic

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hung-Chi Chen, PhD

Role: CONTACT

+886-975365859

Chia-Yi Li, MD

Role: CONTACT

+886-2-27400058 ext. 556

Facility Contacts

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Chia-Yi Li, MD

Role: primary

+886-2-27400058 ext. 556

Hung-Chi Chen, PhD

Role: primary

+886-975365859

References

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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.

Reference Type BACKGROUND
PMID: 24187660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32477165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35204279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31498249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34656060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24227802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28834388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28549842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31490199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37026241 (View on PubMed)

Other Identifiers

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202401405A3

Identifier Type: -

Identifier Source: org_study_id

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