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Clinical Trials/NCT02429609
NCT02429609CompletedNot Applicable

Exploring the Psychophysics of Keratoconus Using the Moorfields Acuity Chart

Moorfields Eye Hospital NHS Foundation Trust0 sites80 target enrollmentStarted: April 15, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Primary Endpoint
The relative difference in visual acuity measurement between subjects with and without keratoconus when examined with different types of visual acuity chart.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • Not provided

Arms & Interventions

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)

Intervention: 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)

Intervention: Moorfields Acuity Chart (Device)

Outcomes

Primary Outcomes

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

Time Frame: 9 months

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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