Keratoconic Subjects Clinical Trial
— MACKOfficial title:
Exploring the Psychophysics of Keratoconus Using the Moorfields Acuity Chart
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 |
Verified date | April 2022 |
Source | Moorfields Eye Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Moorfields Eye Hospital NHS Foundation Trust |
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 |