Objective Visual Quality Analysis System is Used in Cataract

February 13, 2021 updated by: Yukan Huang, Wuhan Union Hospital, China

Objective Visual Quality Analysis System is Used to Evaluate the Effect of Cataract Surgery and Manage Postoperative Complications

The Objective Visual Quality Analysis System (OQAS) is a new inspection technology used to objectively assess the visual quality of the human eye. The investigators use this advanced technology to evaluate and follow up cataract patients before and after surgery, and observe the incidence, severity, and treatment effects of postoperative complications such as postoperative complications, and analyze the severity and artificial The influence of lens type, postoperative time, systemic diseases and other factors on the effect of cataract surgery, in order to discover the key factors that affect the effect of cataract surgery and the management of complications, and provide a useful reference for improving the level of cataract prevention and treatment in China

Study Overview

Status

Status

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

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.

Detailed Description

The Objective Visual Quality Analysis System (OQAS) is a new inspection technology used to objectively assess the visual quality of the human eye. It can detect the impact of ocular refractive system diseases on the objective visual quality of patients. It is currently mainly used to assess the progress of cataracts and help selection the timing of surgery has achieved good clinical results. Before the emergence of OQAS, the rating of cataracts largely relied on the subjective experience of physicians, and OQAS could accurately assess the effects of cataracts on the visual quality of the human eye by quantitatively detecting the light scattering index (OSI) of the refractive medium of the human eye. The impact provides a quantitative evaluation basis for the diagnosis and treatment of cataract and research. However, the application of OQAS in cataract surgery effect evaluation and postoperative complications management is still lacking. After cataract surgery, although the cloudy lens nucleus and cortex have been removed, the original refractive error, vitreous opacity, postoperative posterior capsule folds, posterior dysfunction and many other factors may still affect the objective of the human eye visual quality, and ordinary visual inspection is difficult to find this effect . In addition, preoperative OSI and other indicators of cataract, as an exposure factor, may affect the incidence of postoperative complications, such as after-cataract, macular edema, etc. It is worthy of further study. The application of OQAS can accurately assess the improvement of objective visual quality after cataract surgery, and find and remove other factors that affect OSI. In addition, for one of the most common complications after cataract surgery-after-onset disorder, there is no uniform rating standard in the academic circles, and OQAS can provide objective data for the rating of after-onset disorder, so as to provide information on the postoperative complications such as late-onset disorder. Provide reference for the management of . The research team intends to use OQAS to evaluate and follow up cataract patients before and after surgery, and observe the incidence, severity, and treatment effects of postoperative complications such as after-cataract, analyze the severity of cataract or after-cataract, and intraocular lens The influence of factors such as type, postoperative time, systemic disease on the effect of cataract surgery. We will also rate the posterior disorder based on OSI, and examine the effects and risks of different grades of posterior disorder after laser capsulotomy and other treatments, in order to use OQAS to better guide cataract surgery and postoperative complications management.

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 (Anticipated)

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.
100

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital
        • Contact:
        • Contact:

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Union Hospital Eye Clinic

Description

Inclusion Criteria:

  1. Cataract patients aged 18-90 or patients after cataract surgery；
  2. Signed and dated informed consent；
  3. Commit to abide by the research procedures and cooperate with the implementation of the whole process research

Exclusion Criteria:

  1. Obvious conjunctivitis；
  2. Obvious corneal epithelial punctate staining, corneal epithelial shedding；
  3. Keratitis；
  4. Uveitis；
  5. Corneal scar；
  6. Severe vitreous opacity or hemorrhage；
  7. Other situations deemed unsuitable for inclusion in this study after evaluation by ophthalmologists.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
cataract
Research subjects should meet the following criteria: Signed and dated informed consent form Commitment to abide by the research procedures and cooperate with the implementation of the whole process of research 18-90-year-old cataract patients or patients after cataract surgery
Other: Observational research, not applicable
Observational research, not applicable

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
Measure Description
Time Frame
Change from visual acuity at 6 months
Time Frame: 6 months
VA after cataract surgery 1 week、1month、3month、6month
6 months
Change from Objective Scatter Index at 6 months
Time Frame: 6 months
OSI after cataract surgery 1 week、1month、3month、6month
6 months
Change from Contrast Sensitivity at 6 months
Time Frame: 6 months
CS after cataract surgery 1 week、1month、3month、6month
6 months
Change from Patient Satisfaction Scale at 6 months
Time Frame: 6 months
Patient Satisfaction Scale after cataract surgery 1 week、1month、3month、6month.The minimum values is 0 and maximum values is 100.100 points mean the best outcome.
6 months

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.
Wuhan Union Hospital, China

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: yukan huang, professor, Wuhan Union Hospital, China

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.
February 1, 2021

Primary Completion (Anticipated)

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.
January 1, 2022

Study Completion (Anticipated)

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.
June 1, 2022

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).
February 9, 2021

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.
February 13, 2021

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.
February 17, 2021

Study Record Updates

Last Update Posted (Actual)

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.
February 17, 2021

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.
February 13, 2021

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.
February 1, 2021

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.
  • YKHYK2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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