Contact information
Type
Scientific
Primary contact
Prof Irene Gottlob
ORCID ID
Contact details
Ophthalmology Group
University of Leicester
Robert Kilpatrick Clinical Sciences Building (RKCSB)
Leicester
LE2 7LX
United Kingdom
+44 (0)116 258 6291
ig15@le.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1
Study information
Scientific title
A quantitative study comparing hard and soft contact lenses to spectacles on changes in nystagmus oscillations
Acronym
Study hypothesis
Our hypothesis is that nystagmus can be improved with contact lens wearing. The specific research questions are:
1. Do contact lenses reduce nystagmus and improve vision compared to spectacle wearing?
2. Are hard contact lenses better than soft contact lenses for reducing nystagmus and improving vision in nystagmus?
Ethics approval
Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 06/07/2010, ref: 10/H0406/40
Study design
Randomised single-centre unmasked cross-over study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nystagmus
Intervention
Patients will take part in the trial for a total duration of 8 weeks. This will comprise of 2 weeks of spectacle wear followed by 2 weeks of hard or soft contact lens wear. The next 2 weeks the patients will be wearing the opposite type of contact lens to those prescribed previously and then finally 2 weeks of spectacle wear again. Details of each visit are below:
Visit 1: Optimal refraction determined and glasses prescribed and contact lenses fitted and ordered followed by EXAMINATION 1
Day 1 - 14: Spectacle wearing (minimum of 14 days)
Visit 2 (day 14): EXAMINATION 2 followed by contact lens type 1
Day 15 - 28: Contact lens type 1 wearing
Visit 3 (day 28): EXAMINATION 3 followed by contact lens type 2
Day 29 - 42: Contact lens type 2 wearing
Visit 4 (day 42): EXAMINATION 4 followed by spectacle wearing
Day 43 - 56: Spectacle wearing
Visit 5 (day 56): EXAMINATION 5
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Changes in nysatgmus intensity measured with eye movement recordings, measured at baseline, day 14, day 28, day 42 and day 56.
Secondary outcome measures
Measured at baseline, day 14, day 28, day 42 and day 56:
1. Changes in LogMAR (chart) visual acuity at 4M (with head free)
2. Changes in LogMAR (chart) visual acuity at 0.4M (with head free)
3. Change in gaze dependant visual acuity at 4M
4. Change in nystgamus intensity, NAFX function and reading speed will be evaluated from the eye movement recordings at different fixation points across the horizontal plane
5. Subjective changes in visual function evaluated with the VFQ25
Overall trial start date
01/09/2010
Overall trial end date
01/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infantile nystagmus over the age of 16 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
28
Participant exclusion criteria
1. Currently involved in surgical or pharmacological trials for the treatment of nystagmus
2. Previous corneal trauma or intolerence to contact lens wearing
Recruitment start date
01/09/2010
Recruitment end date
01/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leicester
Leicester
LE2 7LX
United Kingdom
Sponsor information
Organisation
University of Leicester (UK)
Sponsor details
Faculty of Medicine and Biological Sciences (MSB)
University Road
Leicester
LE2 7LX
United Kingdom
+44 (0)116 223 1262
gjh13@leicester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Leicester (UK)
Alternative name(s)
UoL
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24811959