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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02429609
Other study ID # ANDO1009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2015
Est. completion date April 30, 2016

Study information

Verified date April 2022
Source Moorfields Eye Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 30, 2016
Est. primary completion date April 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Moorfields Acuity Chart


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary The relative difference in visual acuity measurement between subjects with and without keratoconus when examined with different types of visual acuity chart. 9 months
Secondary The relationship (if any) between optical imperfections (high order aberrations) and measurements of visual acuity when measured using different test chart designs. 9 months