NCT05394987招募中不适用
Spectacle Correction for the Treatment of Amblyopia
Centre for Eye and Vision Research2 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2022年6月13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
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity of the amblyopic eye pre-intervention
研究概览
简要总结
Amblyopia is a developmental anomaly resulting from abnormal visual experiences in early life. Amblyopia causes reduced visual acuity in the absence of a pathology. Adult sensory systems are believed to be structurally invariant beyond early, critical periods of development. However, recent evidence suggest that visual functions in adults with amblyopia can be improved with optical correction alone. This study aims to investigate whether improvements in best corrected visual acuity and other visual functions can result following appropriate optical correction in adults with amblyopia. Functional measures relating to vision, binocular vision, and eye movements will be used to assess the efficacy of refractive correction for improving vision. This study will help us better understand the improvements in visual functions following optical correction, as well as the mechanisms underlying neuroplasticity in adults with amblyopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-39 (inclusive) years of age
- •Anisometropic amblyopia (difference of ≥0.50D spherical equivalent or ≥1.50D astigmatism between eyes) or mixed mechanism amblyopia (strabismus and anisometropia)
- •Best corrected visual acuity (BCVA) in the amblyopic eye of 0.3 logMAR to 1.0 logMAR (inclusive)
- •BCVA in the non-amblyopic eye of 0.1 logMAR or better, and an interocular VA difference of 2 logMAR lines or more
- •Difference of 1.00D or more between current refractive correction and study prescription
- •Good general health
排除标准
- •Other pathological ocular anomalies known to cause reduced visual acuity
- •Presbyopia (based on amplitude of accommodation)
- •Inability to tolerate prescribed refractive correction in spectacles (e.g., due to aniseikonia)
- •Contraindication to cycloplegic eye drops
- •Currently under amblyopia treatment/therapy
- •Inability to comprehend test instructions and/or provide consent
- •Eccentric fixation
- •>-6.00DS of myopia in either eye with spectacles
- •Bilateral amblyopia
- •Presence of amblyopia that is not due to strabismus and/or anisometropia
- •Presence of (current or previous) psychiatric, visual, or neurological disorders
研究组 & 干预措施
Optical correction
Experimental
Prescription of spectacles for full-time wear to correct refractive error
干预措施: Spectacles (Device)
结局指标
主要结局
Best corrected visual acuity of the amblyopic eye pre-intervention
时间窗: Approx. 5 mins, baseline (day 1 of spectacle wear)
The size of the smallest line of letters read accurately on an ETDRS chart.
Best corrected visual acuity of the amblyopic eye post-intervention
时间窗: Approx. 5 mins, on completion of study (week 24)
The size of the smallest line of letters read accurately on an ETDRS chart.
次要结局
- Best corrected visual acuity of the amblyopic eye during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Fellow eye distance visual acuity pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Fellow eye distance visual acuity during-intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Fellow eye distance visual acuity post-intervention(Approx. 5 mins, on completion of study (week 24))
- Binocular distance visual acuity post-intervention(Approx. 5 mins, on completion of study (week 24))
- Near visual acuity of amblyopic eye pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Near visual acuity of fellow eye during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Near binocular visual acuity during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Stereopsis pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Stereopsis during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Binocular distance visual acuity pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Binocular distance visual acuity during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Near visual acuity of amblyopic eye post-intervention(Approx. 5 mins, on completion of study (week 24))
- Near visual acuity of amblyopic eye during intervention(Approx. 5 mins,every 4 weeks from start of intervention)
- Near visual acuity of fellow eye pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Near visual acuity of fellow eye post-intervention(Approx. 5 mins, on completion of study (week 24))
- Near binocular visual acuity pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Near binocular visual acuity post-intervention(Approx. 5 mins, on completion of study (week 24))
- Amblyopic eye contrast sensitivity pre-intervention(Approx. 10 mins, baseline (day 1 of spectacle wear))
- Amblyopic eye contrast sensitivity post-intervention(Approx. 10 mins, on completion of study (week 24))
- Amblyopic eye contrast sensitivity during intervention(Approx. 10 mins, every 4 weeks from start of intervention)
- Stereopsis post-intervention(Approx. 5 mins, on completion of study (week 24))
- Angle of strabismus post-intervention(Approx. 5 mins, on completion of study (week 24))
- Interocular suppression pre-intervention(Approx. 10 mins, baseline (day 1 of spectacle wear))
- Interocular suppression post-intervention(Approx. 10 mins, on completion of study (week 24))
- Angle of strabismus during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Fellow (non-amblyopic) eye fixation stability during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Quality of life pre-intervention(Approx.15-20 mins, baseline (day 1 of spectacle wear))
- Angle of strabismus pre-intervention(Approx. 5 mins,baseline (day 1 of spectacle wear))
- Amblyopic eye fixation stability pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Amblyopic eye fixation stability post-intervention(Approx. 5 mins, on completion of study (week 24))
- Amblyopic eye fixation stability during intervention(Approx. 5 mins, every 4 weeks from start of intervention)
- Fellow (non-amblyopic) eye fixation stability pre-intervention(Approx. 5 mins, baseline (day 1 of spectacle wear))
- Fellow (non-amblyopic) eye fixation stability post-intervention(Approx. 5 mins, on completion of study (week 24))
- Interocular suppression during intervention(Approx. 10 mins, every 4 weeks from start of intervention)
- Quality of life post-intervention(Approx. 15-20 mins, on completion of study (week 24))
研究者
研究点 (2)
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