Optical treatment of nystagmus
| ISRCTN | ISRCTN80219391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80219391 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 08/07/2010
- Registration date
- 11/08/2010
- Last edited
- 02/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Irene Gottlob
Scientific
Scientific
Ophthalmology Group
University of Leicester
Robert Kilpatrick Clinical Sciences Building (RKCSB)
Leicester
LE2 7LX
United Kingdom
| Phone | +44 (0)116 258 6291 |
|---|---|
| ig15@le.ac.uk |
Study information
| Study design | Randomised single-centre unmasked cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A quantitative study comparing hard and soft contact lenses to spectacles on changes in nystagmus oscillations |
| Study objectives | 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(s) | Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 06/07/2010, ref: 10/H0406/40 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2010 |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 28 |
| Key inclusion criteria | Infantile nystagmus over the age of 16 years, either sex |
| Key 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 |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leicester
Leicester
LE2 7LX
United Kingdom
LE2 7LX
United Kingdom
Sponsor information
University of Leicester (UK)
University/education
University/education
Faculty of Medicine and Biological Sciences (MSB)
University Road
Leicester
LE2 7LX
England
United Kingdom
| Phone | +44 (0)116 223 1262 |
|---|---|
| gjh13@leicester.ac.uk | |
| Website | http://www.le.ac.uk/sm/le |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
University/education
University of Leicester (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UoL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2014 | Yes | No |
