Using Psychophysics Methods to Investigate Sensory Dominance After Cataract Surgery

Active, not recruiting

• Conditions: Cataract

• Registration Number: NCT06751342
• Lead Sponsor: Wenzhou Medical University

Brief Summary

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular Dominance Index (ODI)	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.
Perceptual Phase	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.

Trial Locations

Locations (1)

Ophthalmology and Optometry Hospital, Wenzhou; 🇨🇳 Wenzhou, Zhejiang, China