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临床试验/NCT06751342
NCT06751342进行中(未招募)不适用

Using Psychophysics Methods to Investigate Sensory Dominance After Cataract Surgery

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
96
试验地点
1
主要终点
Perceptual Phase

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Perceptual Phase

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

研究点 (1)

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