The Cohort Study of Pediatric Cataract

September 26, 2022 updated by: Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University
This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.

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.

Detailed Description

Pediatric cataract, one of the leading causes of childhood blindness globally, is complex and of great difficulty in treatment. Pediatric patients with cataract (congenital, traumatic or complicated) are enrolled. In this study, investigators will compare ocular parameter changes, different surgical/vision timing or recovery strategies and adverse effects among young children （age < 18 yo）before and after cataract surgery. The influence on psychology and cognitive function will be taken into consideration as well. The whole blood samples of participants and parents are collected and retained in our biobank for gene sequencing, hoping to explore the genetic factors in association with pathogenesis. For children received cataract surgery, samples of partial anterior capsular tissue and 1 ml aqueous humor were collected during operation for further analysis. Multimodal artificial intelligence analyses are performed to establish accurate diagnosis/treatment scheme and disease prediction model.

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.
5000

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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center
        • 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

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a retrospective-prospective bidirectional cohort study. Patients aged < 18 yo at the 1st visit are enrolled.

Description

Inclusion Criteria:

  • aged < 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent

Exclusion Criteria:

  • adults

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
Measure Description
Time Frame
Best-corrected visual acuity changes
Time Frame: Baseline and through study completion, an average of 1 year
Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time
Baseline and through study completion, an average of 1 year
Intraocular pressure changes
Time Frame: Baseline and through study completion, an average of 1 year
Intraocular pressures are measured by NCT machine
Baseline and through study completion, an average of 1 year
Refractive power changes
Time Frame: Baseline and through study completion, an average of 1 year
Refractive power are measured at baseline and every visit at least every 1 year
Baseline and through study completion, an average of 1 year
Ocular biological measurements changes
Time Frame: Baseline and through study completion, an average of 1 year
Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance
Baseline and through study completion, an average of 1 year
Incidence changes of postoperative complications
Time Frame: Baseline and through study completion, an average of 1 year
Incidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on
Baseline and through study completion, an average of 1 year

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
Measure Description
Time Frame
Other factors changes
Time Frame: Baseline and through study completion, an average of 1 year
Sleep, depression, cognitive function are measured by questionnaires. Self-Rating Scale of Sleep: minimum value-1 point, maximum value-50, and higher scores mean worse outcome. Hamilton Depression Scale: <7 points-normal, and higher scores mean worse outcome. Loewenstein Cognitive Assessment: for every question, minimum 1 point, and maximum 4 points. Higher scores mean worse outcomes.
Baseline and through study completion, an average of 1 year
BMI changes
Time Frame: Baseline and through study completion, an average of 1 year
BMI is measured by technicians in every visit
Baseline and through study completion, an average of 1 year
Blood pressure changes
Time Frame: Baseline and through study completion, an average of 1 year
Diastolic and systolic blood pressure are measured by technicians in every visit
Baseline and through study completion, an average of 1 year
Stereopsis changes
Time Frame: Baseline and through study completion, an average of 1 year
Stereopsis is measured by Randot Stereotest
Baseline and through study completion, an average of 1 year
Optical coherence tomography (OCT) changes
Time Frame: Baseline and through study completion, an average of 1 year
Retinal thickness is measured and analyzed by OCT
Baseline and through study completion, an average of 1 year

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.
Zhongshan Ophthalmic Center, Sun Yat-sen University

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.
August 22, 2022

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, 2032

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.
February 1, 2032

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).
June 6, 2022

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.
July 20, 2022

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.
July 25, 2022

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.
September 27, 2022

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.
September 26, 2022

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.
September 1, 2022

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.
  • 2022KYPJ099

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

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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