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

Recruiting

• Conditions: Cataract; Myopia

• Registration Number: NCT06743594
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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. 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

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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TAC in tears at 1 week	Before the operation and 1 week after surgery.	Change of Total Antioxidant Capacity (TAC) from Baseline to 1 week after surgery.
TAC in tears at 1 month	Before the operation and 1 month after surgery.	Change of Total Antioxidant Capacity (TAC) from Baseline to 1 month after surgery.
TAC in tears at 2 months	Before the operation and 2 months after surgery.	Change of Total Antioxidant Capacity (TAC) from Baseline to 2 months after surgery.
TAC in tears at 3 months	Before the operation and 3 months after surgery.	Change of Total Antioxidant Capacity (TAC) from Baseline to 3 months after surgery.
AA in tears at 1 week	Before the operation and 1 week after surgery.	Change of Ascorbic Acid (AA) from Baseline to 1 week after surgery.
AA in tears at 1 month	Before the operation and 1 month after surgery.	Change of Ascorbic Acid (AA) from Baseline to 1 month after surgery.
AA in tears at 2 months	Before the operation and 2 months after surgery.	Change of Ascorbic Acid (AA) from Baseline to 2 months after surgery.
AA in tears at 3 months	Before the operation and 3 months after surgery.	Change of Ascorbic Acid (AA) from Baseline to 3 months after surgery.
ROS in tears at 1 week	Before the operation and 1 week after surgery.	Change of Reactive Oxygen Species (ROS) from Baseline to 1 week after surgery.
ROS in tears at 1 month	Before the operation and 1 month after surgery.	Change of Reactive Oxygen Species (ROS) from Baseline to 1 month after surgery.
ROS in tears at 2 months	Before the operation and 2 months after surgery.	Change of Reactive Oxygen Species (ROS) from Baseline to 2 moths after surgery.
ROS in tears at 3 months	Before the operation and 3 months after surgery.	Change of Reactive Oxygen Species (ROS) from Baseline to 3 months after surgery.
TAC in aqueous humor at the next day	Before the operation and one day after surgery.	Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery
AA in aqueous humor at the next day	Before the operation and one day after surgery.	Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery
ROS in aqueous humor at the next day	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 Outcome Measures

Name	Time	Method
BCVA	Before surgery	Examination of best corrected visual acuity (BCVA)
UCVA at 1 week	1 week after surgery	Examination of uncorrected visual acuity (UCVA)
UCVA at 1 month	1 month after surgery	Examination of uncorrected visual acuity (UCVA)
UCVA at 2 months	2 months after surgery	Examination of uncorrected visual acuity (UCVA)
UCVA at 3 months	3 months after surgery	Examination of uncorrected visual acuity (UCVA)

Trial Locations

Locations (2)

Taipei Nobel Eye Clinic; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan