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ISRCTN
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ISRCTN80219391
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ClinicalTrials.gov identifier
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Public title
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Optical treatment of nystagmus
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Scientific title
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A quantitative study comparing hard and soft contact lenses to spectacles on changes in nystagmus oscillations
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Acronym
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N/A
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Serial number at source
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Version 1
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Study hypothesis
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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?
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Lay summary
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Ethics approval
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Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1 approved on the 6th July 2010 (ref: 10/H0406/40)
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Study design
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Randomised single centre unmasked cross-over study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nystagmus
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Participants - inclusion criteria
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Infantile nystagmus over the age of 16 years, either sex
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Participants - exclusion criteria
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1. Currently involved in surgical or pharmacological trials for the treatment of nystagmus
2. Previous corneal trauma or intolerence to contact lens wearing
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Anticipated start date
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01/09/2010
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Anticipated end date
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01/09/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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28
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Interventions
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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
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Primary outcome measure(s)
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Changes in nysatgmus intensity measured with eye movement recordings, measured at baseline, day 14, day 28, day 42 and day 56.
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Secondary outcome measure(s)
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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
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Sources of funding
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University of Leicester (UK)
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Trial website
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Publications
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Contact name
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Prof
Irene
Gottlob
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Address
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Ophthalmology Group
University of Leicester
Robert Kilpatrick Clinical Sciences Building (RKCSB)
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City/town
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Leicester
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Zip/Postcode
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LE2 7LX
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Country
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United Kingdom
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Tel
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+44 (0)116 258 6291
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Fax
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+44 (0)116 255 8810
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Email
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ig15@le.ac.uk
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Sponsor
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University of Leicester (UK)
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Address
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Faculty of Medicine and Biological Sciences (MSB)
University Road
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City/town
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Leicester
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Zip/Postcode
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LE2 7LX
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Country
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United Kingdom
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Tel
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+44 (0)116 223 1262
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Fax
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+44 (0)116 252 3031
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Email
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gjh13@leicester.ac.uk
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Sponsor website:
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http://www.le.ac.uk/sm/le
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Date applied
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08/07/2010
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Last edited
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11/08/2010
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Date ISRCTN assigned
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11/08/2010
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