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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nobel Eye Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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