NCT06751342

Brief Summary

Using Psychophysics Methods for Quantitative Assessment of Sensory Binocular Imbalance After Cataract Surgery

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 20, 2024

Last Update Submit

December 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Perceptual Phase

    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)

    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.

Study Arms (6)

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

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology and Optometry Hospital, Wenzhou

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

December 1, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations