Optical treatment of nystagmus
| ISRCTN | ISRCTN80219391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80219391 |
| Protocol serial number | Version 1 |
| Sponsor | University of Leicester (UK) |
| Funder | University of Leicester (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-centre unmasked cross-over study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant 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(s) |
Changes in nysatgmus intensity measured with eye movement recordings, measured at baseline, day 14, day 28, day 42 and day 56. |
| Key secondary outcome measure(s) |
Measured at baseline, day 14, day 28, day 42 and day 56: |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
LE2 7LX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
