Keratoconus Clinical Trial
Official title:
A Randomised Controlled Research to Asses the Clinical Performance and Effect on Vision Related Quality of Life of Rigid Gas Permeable Scleral Versus Corneal Contact Lenses for Keratoconus and Other Irregular Cornea Disorders
Verified date | August 2019 |
Source | London South Bank University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The most common causes for irregular cornea (IC) in hospital contact lens practice are
Keratoconus (KC) and related cornea thinning disorders. These conditions cause mild to marked
impairment of vision and cannot be effectively corrected by spectacles and soft contact
lenses. The gold standard in the management of KC is Corneal Rigid Gas Permeable contact
lenses (corneal lenses), which correct approximately 90% of the corneal irregularity.
Compared with a normal cornea, the cornea in KC is irregular and this results in a compromise
to the fit of rigid corneal lenses. Specifically, they bear on the cornea and this, together
with the vulnerability of the cornea in KC, are implicated in corneal scarring, and disease
progression as well as a significantly reduced vision related quality of life (QoL) in KC
compared with corneal lens wearers who have no KC.
In cases where the compromise fit of corneal lenses proves problematic, large diameter
Scleral RGP contact lenses (scleral lenses) may be used as a problem solver. Unlike the
smaller corneal lenses which bear on the cornea, the scleral lenses completely bridge over
the cornea and bear on the sclera.
The aim of this research is to investigate the performance of scleral lenses in KC
participants who habitually wear corneal lenses.
The research question: is there a measurable difference in the visual performance and visual
quality of life in participants with Irregular cornea disorders like keratoconus and other
related conditions, who habitually wear corneal lenses in comparison with scleral lenses.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 29, 2019 |
Est. primary completion date | January 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of keratoconus or related corneal irregularity - Age 18 years to 69 years. Exclusion Criteria: - Good visual quality with soft contact lenses and or spectacles |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Central Middlesex Hospital | London |
Lead Sponsor | Collaborator |
---|---|
London South Bank University |
United Kingdom,
Visser ES, Van der Linden BJ, Otten HM, Van der Lelij A, Visser R. Medical applications and outcomes of bitangential scleral lenses. Optom Vis Sci. 2013 Oct;90(10):1078-85. doi: 10.1097/OPX.0000000000000018. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Monocular Best Corrected Visual Acuity (BCVA) | High contrast BCVA will be measured by the specially constructed crowded, Logarithmic Minimum Angle of Resolution (LogMAR), Early Treatment Diabetic Retinopathy Survey (ETDRS) letter charts. An average score of 3 different, randomly presented charts will be taken as the final acuity score. It will be performed utilising the CSV1000E, under the established recommended standardised testing conditions utilised in a multitude of research protocols. | Baseline and after a minimum of 6 weeks of wear of each contact lens type, report at study completion | |
Secondary | Contrast Sensitivity Function | The Contrast Sensitivity Function (CSF) will be assessed at each of the four spatial frequencies 3, 6, 12 and 18 Cycles Per Degree (CPD) averaging the results from 2 different charts with sinusoidal grating patterns. This will be performed utilising the CSV1000E, under the established recommended standardised testing conditions utilised in a multitude of research protocols. | Measure at recruitment (Baseline), subsequent measurement after 6 weeks of wear, of lens 1 and 6 weeks of wear of lens 2. Study completion after 6-12 months. | |
Secondary | The National Eye Institute-Visual Function Questionnaire (NEI-VFQ) | The National Eye Institute-Visual Function Questionnaire (NEI-VFQ) (Mangione 2000) is a vision-related quality of life instrument designed to assess patients' perception of visual function and quality of life. The measurements include general health, general vision, ocular pain, near and distance activities, driving, colour vision, and peripheral vision. There are four components of psychological well being, these are; social function, mental health, role difficulties, and dependency function. It has been used to characterize the quality of life for patients with uveitis, diabetic retinopathy, glaucoma, and age-related macular degeneration (Mangione, Lee et al. 2001) | Measure at recruitment (Baseline), subsequent measurement after 6 weeks of wear, of lens 1 and 6 weeks of wear of lens 2. Study completion after 6-12 months. | |
Secondary | The Levit Subjective Comfort and Vision Scales | The Levit Subjective Comfort Scale (LSCS) and The Levit Subjective Vision Scale (LSVS) are Likert like scales which grade the participants' perception of their comfort and vision in contact lenses, on a scale from 1( worse) to 10 (best). | Measure at recruitment (Baseline), subsequent measurement after 6 weeks of wear, of lens 1 and 6 weeks of wear of lens 2. Study completion after 6-12 months. | |
Secondary | The final lens choice | Each participant chose one of the two experimental lenses they wished to keep for future habitual use | At study completion after 6-12 months |
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