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AzTrials

CataractNCT06743594

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

An observational study of Cataract and Myopia, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Cataract, Myopia
How many people
60 participants
Where
2 sitesTaiwan
Study dates
14 Mar 2025to 29 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Taipei Nobel Eye Clinic

    Taipei, 100

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

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.

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.

Read the 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.

Conditions
Cataract, Myopia
Keywords
antioxidants
Medical subject headings
Cataract, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06743594
Study groupRoleWhat they receive
LASIKFemtosecond-LASIK in myopia
KLExKerato-lenticule Extraction in myopia
Traditional Cataract SurgeryCataract Surgery with Phacoemulsification
Laser-Assisted Cataract SurgeryCataract Surgery with LenSx Femtosecond Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TAC in tears at 1 week

    Change of Total Antioxidant Capacity (TAC) from Baseline to 1 week after surgery.

    Measured: Before the operation and 1 week after surgery.

  2. TAC in tears at 1 month

    Change of Total Antioxidant Capacity (TAC) from Baseline to 1 month after surgery.

    Measured: Before the operation and 1 month after surgery.

  3. TAC in tears at 2 months

    Change of Total Antioxidant Capacity (TAC) from Baseline to 2 months after surgery.

    Measured: Before the operation and 2 months after surgery.

  4. TAC in tears at 3 months

    Change of Total Antioxidant Capacity (TAC) from Baseline to 3 months after surgery.

    Measured: Before the operation and 3 months after surgery.

  5. AA in tears at 1 week

    Change of Ascorbic Acid (AA) from Baseline to 1 week after surgery.

    Measured: Before the operation and 1 week after surgery.

  6. AA in tears at 1 month

    Change of Ascorbic Acid (AA) from Baseline to 1 month after surgery.

    Measured: Before the operation and 1 month after surgery.

  7. AA in tears at 2 months

    Change of Ascorbic Acid (AA) from Baseline to 2 months after surgery.

    Measured: Before the operation and 2 months after surgery.

  8. AA in tears at 3 months

    Change of Ascorbic Acid (AA) from Baseline to 3 months after surgery.

    Measured: Before the operation and 3 months after surgery.

  9. ROS in tears at 1 week

    Change of Reactive Oxygen Species (ROS) from Baseline to 1 week after surgery.

    Measured: Before the operation and 1 week after surgery.

  10. ROS in tears at 1 month

    Change of Reactive Oxygen Species (ROS) from Baseline to 1 month after surgery.

    Measured: Before the operation and 1 month after surgery.

  11. ROS in tears at 2 months

    Change of Reactive Oxygen Species (ROS) from Baseline to 2 moths after surgery.

    Measured: Before the operation and 2 months after surgery.

  12. ROS in tears at 3 months

    Change of Reactive Oxygen Species (ROS) from Baseline to 3 months after surgery.

    Measured: Before the operation and 3 months after surgery.

  13. TAC in aqueous humor at the next day

    Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery

    Measured: Before the operation and one day after surgery.

  14. AA in aqueous humor at the next day

    Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery

    Measured: Before the operation and one day after surgery.

  15. ROS in aqueous humor at the next day

    Change of Reactive Oxygen Species (ROS) in aqueous humor from Baseline to one day after surgery

    Measured: Before the operation and one day after surgery.

Secondary outcomes (5)

  1. BCVA

    Examination of best corrected visual acuity (BCVA)

    Measured: Before surgery

  2. UCVA at 1 week

    Examination of uncorrected visual acuity (UCVA)

    Measured: 1 week after surgery

  3. UCVA at 1 month

    Examination of uncorrected visual acuity (UCVA)

    Measured: 1 month after surgery

  4. UCVA at 2 months

    Examination of uncorrected visual acuity (UCVA)

    Measured: 2 months after surgery

  5. UCVA at 3 months

    Examination of uncorrected visual acuity (UCVA)

    Measured: 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start14 Mar 2025
  3. Primary completion13 Oct 2025
  4. Study completion29 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06743594
Sponsor's protocol ID
202401405A3
Status last verified
Mar 2026
First submitted
17 Dec 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28549842

  • 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.

    PubMed 31490199

  • 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.

    PubMed 37026241

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Myopia, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TAC in tears at 1 week (time frame: Before the operation and 1 week after surgery.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06743594, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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