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临床试验/NCT02429609
NCT02429609已完成不适用

Exploring the Psychophysics of Keratoconus Using the Moorfields Acuity Chart

Moorfields Eye Hospital NHS Foundation Trust0 个研究点目标入组 80 人开始时间: 2015年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
The relative difference in visual acuity measurement between subjects with and without keratoconus when examined with different types of visual acuity chart.

研究概览

简要总结

The measurement of visual acuity is made using black letters of varying size superimposed on a uniform white background. The objective is to determine the smallest letter, or optotype, that can be correctly identified. One limitation of current tests is the variability of measurements, this making it difficult for clinicians to determine if changes in visual acuity are related to ocular disease. This variability has been attributed to the design of current optotypes, in particular their differing legibilities. Our group has recently demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters with a black core and a white border presented on a grey background, reduces the variability of visual acuity measurements. In this study the investigators wish to determine if changes in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape, may be detected more easily using the Moorfields Acuity Chart compared with conventional letter charts.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Keratoconic subjects (50):
  • •Age 18-40 years.
  • •The presence of keratoconus in at least one eye.
  • •The absence of significant media opacities (e.g. cataract, corneal scarring).
  • •The absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis).
  • •The absence of amblyopia in the test eye.
  • •No previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.)
  • •Best corrected visual acuity better than or equal to 6/60 (1.0 logMAR).
  • •Pupil diameter ≥3 mm and ≤7 mm in normal room illumination.
  • •Healthy subjects (30):
  • •Age 18-35 years.
  • •The absence of clinically significant keratoconus.
  • •The absence of significant media opacities. (e.g. cataract, corneal scarring).
  • •The absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis).
  • •The absence of amblyopia in the test eye.
  • •No previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.)
  • •Best corrected visual acuity better than or equal to 6/9 (0.1 logMAR).
  • •Pupil diameter ≥3 mm and ≤7 mm in normal room illumination.

排除标准

  • 未提供

研究组 & 干预措施

Keratoconic subjects

Experimental
  1. Short clinical interview (Questions pertaining to ocular and systemic health, medications, family history and date of birth). (approx. 2 minutes)
  2. Visual acuity measurement using EDTRS chart at 4 m (approx. 4 minutes)
  3. Refraction: retinoscopy and subjective, at 4m (approx. 10 minutes)
  4. Anterior eye examination (approx. 4 minutes)
  5. Fundus examination using binocular indirect ophthalmoscopy or a standard ophthalmoscope - to screen for eye disease that is likely to affect visual ability in this study. (approx. 5 minutes)
  6. Corneal topography measurement with an Oculus Pentacam (Oculus Gmbh., Germany). (approx. 5 minutes)

Two measurements of visual acuity will be made:

  1. Standard ETDRS logMAR acuity measurement (5 minutes)
  2. Vanishing Optotype logMAR acuity measurement (5 minutes)

干预措施: Moorfields Acuity Chart (Device)

Healthy subjects

Experimental
  1. Short clinical interview (Questions pertaining to ocular and systemic health, medications, family history and date of birth). (approx. 2 minutes)
  2. Visual acuity measurement using EDTRS chart at 4 m (approx. 4 minutes)
  3. Refraction: retinoscopy and subjective, at 4m (approx. 10 minutes)
  4. Anterior eye examination (approx. 4 minutes)
  5. Fundus examination using binocular indirect ophthalmoscopy or a standard ophthalmoscope - to screen for eye disease that is likely to affect visual ability in this study. (approx. 5 minutes)
  6. Corneal topography measurement with an Oculus Pentacam (Oculus Gmbh., Germany). (approx. 5 minutes)

Two measurements of visual acuity will be made:

  1. Standard ETDRS logMAR acuity measurement (5 minutes)
  2. Vanishing Optotype logMAR acuity measurement (5 minutes)

干预措施: Moorfields Acuity Chart (Device)

结局指标

主要结局

The relative difference in visual acuity measurement between subjects with and without keratoconus when examined with different types of visual acuity chart.

时间窗: 9 months

次要结局

  • The relationship (if any) between optical imperfections (high order aberrations) and measurements of visual acuity when measured using different test chart designs.(9 months)

研究者

申办方类型
Other
责任方
Sponsor

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