Using Psychophysics Methods to Investigate Sensory Dominance After Cataract Surgery

December 20, 2024 updated by: Yune Zhao, Wenzhou Medical University
Using Psychophysics Methods for Quantitative Assessment of Sensory Binocular Imbalance After Cataract Surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

Using binocular phase combination paradigms and binocular rivalry paradigms to quantitatively assess the degree of sensory binocular imbalance in patients following cataract surgery, investigating the relationship between unilateral and bilateral cataracts in children and varying severities of cataracts in adults with respect to sensory ocular dominance, and forecasting the postoperative quality of life for patients.

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 (Estimated)

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.
96

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

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Ophthalmology and Optometry Hospital, Wenzhou

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"

Description

Inclusion Criteria:

  1. Ages between 6 and 90 years old, and the individual or legal guardian is capable of understanding and voluntarily signing an informed consent form;
  2. No history of ocular trauma or intraocular surgery, no physical or medical treatments have been undergone, and the clinical diagnosis in the medical records is age-related, congenital, or developmental cataract patients;
  3. Best-corrected visual acuity in both eyes is greater than 0.8 before the study, fusion ability is normal as checked by Worth's 4-dot test, and at least 1 month has passed since the last surgery;
  4. Good communication skills and the ability to understand and grasp the trial;
  5. No significant contraindications to surgery found in preoperative systemic and ocular examinations.

Exclusion Criteria:

  1. Patients with traumatic or complex cataracts;
  2. Those diagnosed with glaucoma before or after surgery;
  3. Individuals with a history of intraocular surgery (such as vitrectomy) or laser treatment;
  4. Exclude those with severe ocular comorbidities (including microphthalmia, aphakia, anterior segment dysgenesis, uveitis, optic nerve dysplasia, retinopathy of prematurity, congenital glaucoma, etc.) and severe systemic comorbidities (including syndromes affecting connective tissue function, such as Marfan syndrome, homocystinuria, or Down syndrome, severe birth defects, and epilepsy);
  5. Any systemic diseases related to the eyes, such as rheumatic immune diseases;
  6. Those with surgical records indicating any severe intraoperative complications during cataract surgery;
  7. Individuals who cannot cooperate with the examination.

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

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.
Subjects with Unilateral Congenital Cataract Undergoing Surgery
Subjects with Bilateral Congenital Cataract Undergoing Surgery
Control Group of Children
Subjects with Comparable Degrees of Bilateral Age-Related Cataract
Subjects with Different Degrees of Bilateral Age-Related Cataracts
Subjects with Shallow Anterior Chambers in Both Eyes

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
Perceptual Phase
Time Frame: Each subject undergoes a one-time examination, which lasts for about a year. Each subject's participation in this clinical study will take approximately 0.5 hour.
The perceptual phase when the interocular contrast between the two eyes is 1.
Each subject undergoes a one-time examination, which lasts for about a year. Each subject's participation in this clinical study will take approximately 0.5 hour.
Ocular Dominance Index (ODI)
Time Frame: Each subject undergoes a one-time examination, which lasts for about a year. Each subject's participation in this clinical study will take approximately 0.5 hour.
The ratio of the total time spent by the observer reporting complete dominance of visual stimuli presented to the dominant or non-dominant eye.
Each subject undergoes a one-time examination, which lasts for about a year. Each subject's participation in this clinical study will take approximately 0.5 hour.

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.
Wenzhou Medical University

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.
December 1, 2024

Primary Completion (Estimated)

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.
December 30, 2025

Study Completion (Estimated)

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.
December 30, 2025

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).
December 20, 2024

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.
December 20, 2024

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.
March 25, 2025

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.
March 25, 2025

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 20, 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.
December 1, 2024

More Information

Terms related to this study

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.
  • psychophysical methods

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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