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NCT Number: NCT06743594

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Myopia Refractive Errors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Nobel Eye Clinic, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. TAC in tears at 1 week

    Time frame: Before the operation and 1 week after surgery.

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

  2. TAC in tears at 1 month

    Time frame: Before the operation and 1 month after surgery.

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

  3. TAC in tears at 2 months

    Time frame: Before the operation and 2 months after surgery.

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

  4. TAC in tears at 3 months

    Time frame: Before the operation and 3 months after surgery.

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

  5. AA in tears at 1 week

    Time frame: Before the operation and 1 week after surgery.

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

  6. AA in tears at 1 month

    Time frame: Before the operation and 1 month after surgery.

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

  7. AA in tears at 2 months

    Time frame: Before the operation and 2 months after surgery.

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

  8. AA in tears at 3 months

    Time frame: Before the operation and 3 months after surgery.

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

  9. ROS in tears at 1 week

    Time frame: Before the operation and 1 week after surgery.

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

  10. ROS in tears at 1 month

    Time frame: Before the operation and 1 month after surgery.

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

  11. ROS in tears at 2 months

    Time frame: Before the operation and 2 months after surgery.

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

  12. ROS in tears at 3 months

    Time frame: Before the operation and 3 months after surgery.

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

  13. TAC in aqueous humor at the next day

    Time frame: Before the operation and one day after surgery.

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

  14. AA in aqueous humor at the next day

    Time frame: Before the operation and one day after surgery.

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

  15. ROS in aqueous humor at the next day

    Time frame: Before the operation and one day after surgery.

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

Secondary outcomes

  1. BCVA

    Time frame: Before surgery

    Examination of best corrected visual acuity (BCVA)

  2. UCVA at 1 week

    Time frame: 1 week after surgery

    Examination of uncorrected visual acuity (UCVA)

  3. UCVA at 1 month

    Time frame: 1 month after surgery

    Examination of uncorrected visual acuity (UCVA)

  4. UCVA at 2 months

    Time frame: 2 months after surgery

    Examination of uncorrected visual acuity (UCVA)

  5. UCVA at 3 months

    Time frame: 3 months after surgery

    Examination of uncorrected visual acuity (UCVA)

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Yi Li, MD

CONTACT

[email protected]

+886-2-27400058 ext. 556

Hung-Chi Chen, PhD

CONTACT

[email protected]

+886-975365859

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Taipei Nobel Eye Clinic

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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