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临床试验/NCT03431454
NCT03431454Unknown2 期

Comparison of Three Vision Therapy Approaches for Convergence Insufficiency

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
48
试验地点
1
主要终点
symptomatic convergence insufficiency

研究概览

简要总结

We compared the effectiveness of three active vision therapy approaches for convergence insufficiency (CI). Patients with eligible criteria and symptomatic CI were included in a prospective study and randomly allocated into three groups. In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week. In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed. For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients between 15 and 35 years of age who have symptomatic CI using the Convergence Insufficiency Symptom Survey (CISS) scoring system.
  • •best-corrected visual acuity ≥ 20/25
  • •exophoria at near at least 4 prism diopters (△) greater than at distance
  • •near point of convergence more than 6.0 cm break
  • •insufficient positive fusional vergence (PFV) (failing Sheard's criterion or PFV ≤ 15 △ base-out) at near distance.

排除标准

  • •amblyopia (VA worse than 20/30 in each eye), presence of manifest strabismus, history of ocular surgery, any systemic disorder, anisometropia of more than 1.5 diopter of myopia or hyperopia or significant refractive error, and nystagmus and usage of medications that may impair accommodation or convergence. ,ocular surface abnormalities or history of ocular allergy or those who had previously been treated for CI

研究组 & 干预措施

home-based vision orthoptic therapy (HBVOT) group

Active Comparator

In the home-based vision orthoptic therapy (HBVOT) group, patients were trained to do the pencil push-ups procedure 15 minutes per day, five days a week

干预措施: trained to do the pencil push-ups procedure (Procedure)

office-based vision orthoptic therapy (OBVOT) group

Active Comparator

In the office-based vision orthoptic therapy (OBVOT) group, 60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed

干预措施: using a major amblyoscope twice weekly with additional home orthoptic therapy (Procedure)

augmented office-based vision orthoptic therapy (AOBVOT) group

Active Comparator

For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.

干预措施: using three diopter over-minus lenses and a base out prism (Procedure)

结局指标

主要结局

symptomatic convergence insufficiency

时间窗: one month

A symptomatic score was an average score of 16 or higher on the CISS(conv-insuff-sympt-scove)

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

Zahra Rabbani Khah

Shahid Beheshti University of Medical Sciences

Shahid Beheshti University of Medical Sciences

研究点 (1)

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