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

Completed

• Conditions: Cataract; Myopia

• Registration Number: NCT05905237
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Status Verified: 2023-07
• Primary Completion: 2023-07-28
• Study Completion: 2023-07-28
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Ascorbic Acid (AA) in tears from Baseline to 1 month after surgery.	Before the operation and 1 month after surgery.
Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery.	During the operation and one day after surgery.
Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 3 months after surgery.	Before the operation and 3 months after surgery.
Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 week after surgery.	Before the operation and 1 week after surgery.
Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 month after surgery.	Before the operation and 1 month after surgery.
Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 6 months after surgery.	Before the operation and 6 months after surgery.
Change of Ascorbic Acid (AA) in tears from Baseline to 6 months after surgery.	Before the operation and 6 months after surgery.
Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery.	During the operation and one day after surgery.
Change of Ascorbic Acid (AA) in tears from Baseline to 1 week after surgery.	Before the operation and 1 week after surgery.
Change of Ascorbic Acid (AA) in tears from Baseline to 3 months after surgery.	Before the operation and 3 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Examination of axial length (AXL).	Before the operation.
Examination of manifest refraction.	One month after surgery.
Examination of anterior chamber depth (ACD).	Before the operation.
Examination of corneal curvature.	One month after surgery.
Examination of uncorrected visual acuity (UCVA).	One month after surgery.
Examination of central corneal thickness (CCT).	One month after surgery.
Examination of lens thickness (LT).	Before the operation.
Examination of best corrected visual acuity (BCVA).	Before the operation.
Examination of intraocular pressure (IOP).	One month after surgery.

Trial Locations

Locations (2)

ChangGungMH; 🇨🇳 Taoyuan, Taoyuan City, Taiwan

Nobel Eye Institute; 🇨🇳 Taipei, Taiwan