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Completed

NCT Number: NCT05905237

Measurement of Antioxidant Activity on Postoperative Inflammation in Patients Undergoing Ophthalmic Surgery

This trial hypothesized that novel laser refractive surgery techniques (PRK, LASIK, SMILE) 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

ChangGungMH, Taoyuan, Taoyuan City, Taiwan

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • over 20 years old (included)
  • 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

Cataract surgery, Femtosecond-LASIK, SMILE

Procedure

Cataract surgery includes both conventional and femtosecond laser assisted. Femtosecond-LASIK and SMILE are options for patients to correct myopia.

Primary outcomes

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

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

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

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

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

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

  4. Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 6 months after surgery.

    Time frame: Before the operation and 6 months after surgery.

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

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

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

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

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

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

  8. Change of Ascorbic Acid (AA) in tears from Baseline to 6 months after surgery.

    Time frame: Before the operation and 6 months after surgery.

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

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

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

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

Secondary outcomes

  1. Examination of best corrected visual acuity (BCVA).

    Time frame: Before the operation.

  2. Examination of uncorrected visual acuity (UCVA).

    Time frame: Before the operation.

  3. Examination of uncorrected visual acuity (UCVA).

    Time frame: One week after surgery.

  4. Examination of uncorrected visual acuity (UCVA).

    Time frame: One month after surgery.

  5. Examination of intraocular pressure (IOP).

    Time frame: Before the operation.

  6. Examination of intraocular pressure (IOP).

    Time frame: One week after surgery.

  7. Examination of intraocular pressure (IOP).

    Time frame: One month after surgery.

  8. Examination of central corneal thickness (CCT).

    Time frame: Before the operation.

  9. Examination of central corneal thickness (CCT).

    Time frame: One week after surgery.

  10. Examination of central corneal thickness (CCT).

    Time frame: One month after surgery.

  11. Examination of axial length (AXL).

    Time frame: Before the operation.

  12. Examination of anterior chamber depth (ACD).

    Time frame: Before the operation.

  13. Examination of lens thickness (LT).

    Time frame: Before the operation.

  14. Examination of manifest refraction.

    Time frame: Before the operation.

  15. Examination of manifest refraction.

    Time frame: One week after surgery.

  16. Examination of manifest refraction.

    Time frame: One month after surgery.

  17. Examination of corneal curvature.

    Time frame: Before the operation.

  18. Examination of corneal curvature.

    Time frame: One week after surgery.

  19. Examination of corneal curvature.

    Time frame: One month after surgery.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Nobel Eye Institute

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Dec 4, 2024

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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