- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06751342
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
Active, not recruiting
Conditions
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
Observational
Enrollment (Estimated)
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
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Zhejiang
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Wenzhou, Zhejiang, China, 325027
- Ophthalmology and Optometry Hospital, Wenzhou
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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
- 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:
- Ages between 6 and 90 years old, and the individual or legal guardian is capable of understanding and voluntarily signing an informed consent form;
- 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;
- 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;
- Good communication skills and the ability to understand and grasp the trial;
- No significant contraindications to surgery found in preoperative systemic and ocular examinations.
Exclusion Criteria:
- Patients with traumatic or complex cataracts;
- Those diagnosed with glaucoma before or after surgery;
- Individuals with a history of intraocular surgery (such as vitrectomy) or laser treatment;
- 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);
- Any systemic diseases related to the eyes, such as rheumatic immune diseases;
- Those with surgical records indicating any severe intraoperative complications during cataract surgery;
- 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 |
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Subjects with Unilateral Congenital Cataract Undergoing Surgery
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Subjects with Bilateral Congenital Cataract Undergoing Surgery
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Control Group of Children
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Subjects with Comparable Degrees of Bilateral Age-Related Cataract
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Subjects with Different Degrees of Bilateral Age-Related Cataracts
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Subjects with Shallow Anterior Chambers in Both Eyes
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What is the study measuring?
Primary Outcome Measures
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.
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The perceptual phase when the interocular contrast between the two eyes is 1.
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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.
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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.
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The ratio of the total time spent by the observer reporting complete dominance of visual stimuli presented to the dominant or non-dominant eye.
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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
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)
December 1, 2024
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
December 20, 2024
First Submitted That Met QC Criteria
December 20, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 20, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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