跳至主要内容
临床试验/NCT06748534
NCT06748534进行中(未招募)不适用

Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility

Superior University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年3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
38
试验地点
1
主要终点
Monocular and Binocular Accommodative Facility (MAF/BAF)

研究概览

简要总结

This Randomized Control Trials Study , conducted in Lahore, Pakistan, investigates the comparative efficacy of two approaches-plus lens addition of +0.75 diopters (D) and vision therapy using the HART chart-for managing accommodative infacility. Accommodative infacility, a condition characterized by the eye's reduced ability to adjust focus between distant and near objects, impacts both visual comfort and performance, particularly during prolonged near work.

详细描述

The study sample comprises 38 participants, aged 15 to 35 years, divided into two groups: one group receiving plus lens addition of +0.75 D and the other undergoing structured vision therapy with the HART chart. Findings revealed that vision therapy was significantly more effective than plus lens addition, with results showing statistical significance at P < 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

入选标准

  • Participants aged 15 to 35 years.
  • Diagnosed with accommodative infacility.
  • Capable of adhering to the full study duration of 6 weeks.
  • Measurable accommodative dysfunction confirmed through baseline eye examinations.
  • Written informed consent from participants or guardians.

排除标准

  • Presence of other significant ocular or neurological conditions.
  • Inability or unwillingness to adhere to the prescribed treatment.
  • Prior treatment for accommodative infacility within the past 6 months.
  • Significant uncorrected refractive errors.
  • Medical contraindications for using plus lenses or vision therapy.

结局指标

主要结局

Monocular and Binocular Accommodative Facility (MAF/BAF)

时间窗: 12 Months

Improvement in accommodative facility measured using Monocular and Binocular Accommodative Facility (MAF/BAF) tests with ±2.00 D flipper lenses. Measurement is recorded in cycles per minute (cpm).

subjective measures of visual comfort

时间窗: 12 Months

Reduction in symptoms of accommodative infacility assessed using a customized performa. Measurement is based on a symptom severity score recorded pre- and post-intervention.

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

Muhammad Naveed Babur

Principal Investigator

Superior University

研究点 (1)

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