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

December 2, 2024 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 106
        • Nobel Eye Institute
    • Taoyuan City
      • Taoyuan, Taoyuan City, Taiwan, 333
        • ChangGungMH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Before the operation and 1 week after surgery.
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.
Before the operation and 1 month after surgery.
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.
Before the operation and 3 months after surgery.
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.
Before the operation and 6 months after surgery.
Change of Ascorbic Acid (AA) in tears from Baseline to 1 week after surgery.
Time Frame: Before the operation and 1 week after surgery.
Before the operation and 1 week after surgery.
Change of Ascorbic Acid (AA) in tears from Baseline to 1 month after surgery.
Time Frame: Before the operation and 1 month after surgery.
Before the operation and 1 month after surgery.
Change of Ascorbic Acid (AA) in tears from Baseline to 3 months after surgery.
Time Frame: Before the operation and 3 months after surgery.
Before the operation and 3 months after surgery.
Change of Ascorbic Acid (AA) in tears from Baseline to 6 months after surgery.
Time Frame: Before the operation and 6 months after surgery.
Before the operation and 6 months after surgery.
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.
During the operation and one day after surgery.
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.
During the operation and one day after surgery.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Nobel Eye Institute

Investigators

  • Study Chair: Hung-Chi Chen, PhD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

July 28, 2023

Study Completion (Actual)

July 28, 2023

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200858B0A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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