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临床试验/NCT02113709
NCT02113709Unknown不适用

Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at All Ages

Mughal Eye Trust Hospital2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
115
试验地点
2
主要终点
Visual Acuity improvement

研究概览

简要总结

Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age.

Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. Patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly for the next 18 months.

详细描述

Amblyopia, ('blunt vision' in Ancient Greek), also known as lazy eye, is a visual deficiency in an eye that is otherwise physically normal, or that is greater than would be expected from any structural abnormalities of the eye. There are unsubstantiated beliefs that it is more difficult to treat amblyopia in older age groups, that children that have already received failed amblyopia therapy do not respond to treatment and that full-time occlusion therapy may result in occlusion (disuse) amblyopia of the good eye. The aim of this study was to assess whether these beliefs are true. Materials and methods This was a prospective, interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia conducted at a tertiary referral center in Lahore, Pakistan, from January 2010 to October 2012. Eligibility criteria included an age of over three years, visual acuity in the amblyopic eye from 6/60 Snellen's or even counting fingers only, visual acuity in the sound eye of 6/6. A complete ophthalmic examination was performed by only one ophthalmologist (SI). This included examining the fixation pattern of both eyes, presence or absence of a phoria or a tropia by a cover-uncover test, fundus examination and color vision using Ishihara color plates. Any case with an organic cause for visual loss was excluded from the study after a thorough ophthalmological examination. Assessment of visual acuity of either eye for both near and distance acuity (Snellen's and ETDRS charts) refraction and Best Corrected Visual Acuity (BCVA) was performed by a trained optician who was masked to the study and patient's demographics.

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
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a visual acuity of 6/60 or 0.1-0.2 ETDRS in one eye and 6/6 or 1.0 ETDRS in the good eye
  • strabismic amblyopia
  • patients of any age were included.

排除标准

  • structural damage to the eye (organic amblyopia)
  • ametropic amblyopia

研究组 & 干预措施

Visual improvement

Experimental

To see how efficiently visual improvement occurs by Full-time Occlusion therapy with an eye patch in severe amblyopia.

干预措施: Occlusion therapy by Eye Patch (Device)

Visual improvement

Experimental

To see how efficiently visual improvement occurs by Full-time Occlusion therapy with an eye patch in severe amblyopia.

干预措施: Occlusion therapy (Device)

结局指标

主要结局

Visual Acuity improvement

时间窗: 3 months

Full-time occlusion therapy of good eye was performed for 2-3 months while closely monitoring the vision of both the good and the amblyopic eye. Vision was assessed by EDTRS Charts as well as Snellen's Chart.

次要结局

  • improvement in stereopsis(1 year)

研究者

发起方
Mughal Eye Trust Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sameera Irfan

Consultant Ophthalmologist

Mughal Eye Trust Hospital

研究点 (2)

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