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临床试验/NCT06622044
NCT06622044招募中不适用

Accommodation and Vergence Exercises Versus Prism Treatment for Small-angle Acute Acquired Concomitant Esotropia

Eye & ENT Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Change in deviation angle at distance and near

研究概览

简要总结

This prospective, single-center, nonrandomized comparative study evaluates 6-month ocular alignment and binocular visual function outcomes following combined accommodation and fusional training or prism correction in patients with small-angle acute acquired comitant esotropia. Treatment was selected through shared decision-making between the patient and the treating clinician according to the clinical presentation and patient preference.

详细描述

Acute acquired concomitant esotropia (AACE) belongs to the category of concomitant strabismus. It is characterized by sudden onset, often accompanied by diplopia, and no change in the strabismus angle of each eye position. In recent years, with the increase in the use of smartphones and other screen devices, the incidence of AACE has been on the rise. Commonly used treatments in clinical practice include surgical treatment, botulinum toxin injection into the medial rectus muscle, and prism treatment. Patients with large-angle esotropia generally require surgical intervention to fundamentally correct patients eye positions and eliminate diplopia. However, surgical treatment requires waiting for six months in order to performed after the strabismus degree is stable. There are also risks of intraoperative trauma and secondary surgery. Patients with early and small-angle esotropia often choose prism treatment.

The principle of prism treatment is light refraction. After light is refracted through a prism, it falls on the fovea of the strabismic eye, eliminating diplopia. In the treatment of AACE, the main target population of prisms is patients with mild strabismus (the strabismus angle is usually less than 25 PD). Wearing prisms can eliminate diplopia and relieve related symptoms, but it does not really correct the strabismus problem.

The high incidence of AACE is related to excessive close work and use of electronic products. Excessive close eye use can lead to accommodative dysfunction. Studies have found that AACE patients have abnormal accommodative function. The accommodative function of AACE patients is weaker than normal, and the accommodation convergence to accommodation (AC/A) ratio is higher than normal. During clinical diagnosis and treatment, the accommodative function of AACE patients was examined and it was found that there was indeed abnormal accommodative function. Based on scientific research findings and the actual basis of clinical practice, improving accommodative function through accommodative training may be a good treatment option for early and small-angle AACE patients. However, existing studies have not fully explored the effectiveness and safety of accommodative exercise in the treatment of small-angle AACE, and there has been no study comparing the therapeutic outcomes of accommodative training and prism treatment on small-angle AACE.

In order to better guide clinical practice, we conducted a prospective, single-center, nonrandomized comparative study to objectively evaluate and compare the therapeutic effects of accommodative training and prism therapy on AACE. It is expected that the research results will provide more treatment options for AACE patients and provide important guidance for clinical selection of appropriate methods to treat small-angle AACE.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 10-40 years (including 10 years and 40 years);
  • Best-corrected visual acuity no worse than 20/20 for both eyes;
  • Deviation angle less than 15 prism diopters (including 15 prism diopters);

排除标准

  • Organic eye diseases;
  • Lesions of the brain;
  • Receiving esotropia therapy(including surgery and prism treatment)
  • Devation angle reducing more than 10 prism diopters after refractive correction

研究组 & 干预措施

Vision therapy group

Experimental

Accommodation facility exercises and divergence exercises

干预措施: Vision therapy group (Other)

Prism group

Active Comparator

wearing prism glasses

干预措施: Prism (Other)

结局指标

主要结局

Change in deviation angle at distance and near

时间窗: 1 weeks, 4weeks, 12 weeks, 24 weeks

the deviation angle measured using the alternate prism cover test

次要结局

  • Changes in stereopsis(1 weeks, 4weeks, 12 weeks, 24 weeks)
  • Changes in accommodation facility(1 weeks, 4weeks, 12 weeks, 24 weeks)
  • Changes in accommodation function(1 weeks, 4weeks, 12 weeks, 24 weeks)
  • Change in accommodation convergence to accommodation(AC/A) ratio(1 weeks, 4weeks, 12 weeks, 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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