Clinical trial NCT06743594: Measurement of Antioxidant Activity and Oxidative Stress in Patients Undergoing Ophthalmic Surgery.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Myopia
Keywords: antioxidants
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Nobel Eye Clinic
First posted: 2024-12-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: TAC in tears at 1 week
timeFrame: Before the operation and 1 week after surgery.
measure: TAC in tears at 1 month
timeFrame: Before the operation and 1 month after surgery.
measure: TAC in tears at 2 months
timeFrame: Before the operation and 2 months after surgery.
measure: TAC in tears at 3 months
timeFrame: Before the operation and 3 months after surgery.
measure: AA in tears at 1 week
timeFrame: Before the operation and 1 week after surgery.
measure: AA in tears at 1 month
timeFrame: Before the operation and 1 month after surgery.
measure: AA in tears at 2 months
timeFrame: Before the operation and 2 months after surgery.
measure: AA in tears at 3 months
timeFrame: Before the operation and 3 months after surgery.
measure: ROS in tears at 1 week
timeFrame: Before the operation and 1 week after surgery.
measure: ROS in tears at 1 month
timeFrame: Before the operation and 1 month after surgery.
measure: ROS in tears at 2 months
timeFrame: Before the operation and 2 months after surgery.
measure: ROS in tears at 3 months
timeFrame: Before the operation and 3 months after surgery.
measure: TAC in aqueous humor at the next day
timeFrame: Before the operation and one day after surgery.
measure: AA in aqueous humor at the next day
timeFrame: Before the operation and one day after surgery.
measure: ROS in aqueous humor at the next day
timeFrame: Before the operation and one day after surgery.
Secondary outcomes:
measure: BCVA
timeFrame: Before surgery
measure: UCVA at 1 week
timeFrame: 1 week after surgery
measure: UCVA at 1 month
timeFrame: 1 month after surgery
measure: UCVA at 2 months
timeFrame: 2 months after surgery
measure: UCVA at 3 months
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Nobel Eye Clinic
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
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citation: 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.
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