跳至主要内容
临床试验/NCT03952702
NCT03952702Unknown不适用

The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia

Ege University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
65
试验地点
1
主要终点
The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.

研究概览

简要总结

In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.

详细描述

Purpose: To evaluate the long-term impact of overminus lenses in intermittent exotropia (IXT), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia.

Materials and Method: Sixty-five consecutive cases of IXT followed for at least 48 months were included. Patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (>-5.0 D), severe hyperopia (>+5.0 D), moderate or severe amblyopia and poor compliance with spectacles were excluded. Data was collected including near stereoacuity, AC/A ratio, control of IXT measured with Newcastle Control Score (NCS) at baseline and in all follow-up visits. Baseline values without overminus threapy were compared with postintervention values at every visit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with IXT
  • prescribed overminus lenses

排除标准

  • a history of previous surgery, ocular pathology
  • convergence insufficiency type IXT
  • presence of any type of ocular deviation except IXT
  • presence of severe myopia (greater than -5.0 D)
  • presence of severe hyperopia (greater than +5.0 D)
  • presence of moderate or severe amblyopia
  • poor compliance with overminus spectacles
  • follow up period of <48 months after intervention.

结局指标

主要结局

The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.

时间窗: 4 years

Overminus lenses were prescribed on the treatment of intermittent exotropia as the first choice. To investigate the effect of overminus lenses on treatment, progress in fusional capability of the patients evaluated with Newcastle control score system were investigated.

The long-term effect of overminus lenses on stereopsis of patients with intermittent exotropia.

时间窗: 4 years

Changes in stereopsis values (arcsec) evaluated with TNO test were observed.

The long-term effect of prescribing overminus lenses on refractive changes.

时间窗: 4 years

Refractive data of the patients in terms of dioptri were measured with autorefractometer during the long-term follow-up period to observe presence of any myopic shift.

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

Elif Demirkilinc Biler

Assoc. Prof., M.D.

Ege University

研究点 (1)

Loading locations...

相似试验

Overminus Lens Therapy in Intermittent | 临床试验