Clinical trial NCT05905237: Measurement of Antioxidant Activity on Postoperative Inflammation in Patients Undergoing Ophthalmic Surgery
Official title: Effects of Laser Species and Ocular Antioxidant Activity on Postoperative Inflammation and Visual Prognosis in Patients Undergoing Ophthalmic Surgery - a Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Myopia
Keywords: antioxidants
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Nobel Eye Institute
First posted: 2023-06-15
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective, non-randomized trial was conducted at the Nobel Eye Clinic. This study included patients with the following conditions: (1) older than 20 years old (inclusive), (2) expected to undergo corneal refractive surgery or cataract surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 week after surgery.
timeFrame: Before the operation and 1 week after surgery.
measure: Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 1 month after surgery.
timeFrame: Before the operation and 1 month after surgery.
measure: Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 3 months after surgery.
timeFrame: Before the operation and 3 months after surgery.
measure: Change of Total Antioxidant Capacity (TAC) in tears from Baseline to 6 months after surgery.
timeFrame: Before the operation and 6 months after surgery.
measure: Change of Ascorbic Acid (AA) in tears from Baseline to 1 week after surgery.
timeFrame: Before the operation and 1 week after surgery.
measure: Change of Ascorbic Acid (AA) in tears from Baseline to 1 month after surgery.
timeFrame: Before the operation and 1 month after surgery.
measure: Change of Ascorbic Acid (AA) in tears from Baseline to 3 months after surgery.
timeFrame: Before the operation and 3 months after surgery.
measure: Change of Ascorbic Acid (AA) in tears from Baseline to 6 months after surgery.
timeFrame: Before the operation and 6 months after surgery.
measure: Change of Total Antioxidant Capacity (TAC) in aqueous humor from Baseline to one day after surgery.
timeFrame: During the operation and one day after surgery.
measure: Change of Ascorbic Acid (AA) in aqueous humor from Baseline to one day after surgery.
timeFrame: During the operation and one day after surgery.
Secondary outcomes:
measure: Examination of best corrected visual acuity (BCVA).
timeFrame: Before the operation.
measure: Examination of uncorrected visual acuity (UCVA).
timeFrame: Before the operation.
measure: Examination of uncorrected visual acuity (UCVA).
timeFrame: One week after surgery.
measure: Examination of uncorrected visual acuity (UCVA).
timeFrame: One month after surgery.
measure: Examination of intraocular pressure (IOP).
timeFrame: Before the operation.
measure: Examination of intraocular pressure (IOP).
timeFrame: One week after surgery.
measure: Examination of intraocular pressure (IOP).
timeFrame: One month after surgery.
measure: Examination of central corneal thickness (CCT).
timeFrame: Before the operation.
measure: Examination of central corneal thickness (CCT).
timeFrame: One week after surgery.
measure: Examination of central corneal thickness (CCT).
timeFrame: One month after surgery.
measure: Examination of axial length (AXL).
timeFrame: Before the operation.
measure: Examination of anterior chamber depth (ACD).
timeFrame: Before the operation.
measure: Examination of lens thickness (LT).
timeFrame: Before the operation.
measure: Examination of manifest refraction.
timeFrame: Before the operation.
measure: Examination of manifest refraction.
timeFrame: One week after surgery.
measure: Examination of manifest refraction.
timeFrame: One month after surgery.
measure: Examination of corneal curvature.
timeFrame: Before the operation.
measure: Examination of corneal curvature.
timeFrame: One week after surgery.
measure: Examination of corneal curvature.
timeFrame: One month after surgery.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: ChangGungMH
state: Taoyuan City
city: Taipei
country: Taiwan
facility: Nobel Eye Institute
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hung-Chi Chen, PhD
role: STUDY_CHAIR
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