CataractNCT06751342
Using Psychophysics Methods to Investigate Sensory Dominance After Cataract Surgery
An observational study of Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
Using Psychophysics Methods for Quantitative Assessment of Sensory Binocular Imbalance After Cataract Surgery Read more about this study
- Who is it for?
- Ages 6 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ophthalmology and Optometry Hospital, Wenzhou
Wenzhou, Zhejiang, 325027
About this study
Using Psychophysics Methods for Quantitative Assessment of Sensory Binocular Imbalance After Cataract Surgery
Read the 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.
- Conditions
- Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Unilateral Congenital Cataract Undergoing Surgery | Not described | |
| Subjects with Bilateral Congenital Cataract Undergoing Surgery | Not described | |
| Control Group of Children | Not described | |
| Subjects with Comparable Degrees of Bilateral Age-Related Cataract | Not described | |
| Subjects with Different Degrees of Bilateral Age-Related Cataracts | Not described | |
| Subjects with Shallow Anterior Chambers in Both Eyes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptual Phase
The perceptual phase when the interocular contrast between the two eyes is 1.
Measured: 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)
The ratio of the total time spent by the observer reporting complete dominance of visual stimuli presented to the dominant or non-dominant eye.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751342
- Sponsor's protocol ID
- psychophysical methods
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Psychophysics Methods to Investigate Sensory Dominance After Cataract Surgery
- ClinicalTrials.gov ID
- NCT06751342
- Acronym / sponsor ID
- psychophysical methods
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using Psychophysics Methods for Quantitative Assessment of Sensory Binocular Imbalance After Cataract Surgery
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Included in Eye Hospital of Wenzhou Medical University for "phacoemulsification combined with intraocular lens implantation"
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.