Condition category
Eye Diseases
Date applied
08/07/2010
Date assigned
11/08/2010
Last edited
02/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.le.ac.uk/sm/le

Funders

Funder type

University/education

Funder name

University of Leicester (UK)

Alternative name(s)

UoL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24811959

Publication citations

Additional files

Editorial Notes