Original articleA Randomized Controlled Trial Comparing Soft Contact Lens and Rigid Gas-Permeable Lens Wearing in Infantile Nystagmus
Section snippets
Trial Design and Study Setting
An unmasked controlled crossover study was performed and stratified for type of IN with a balanced randomization (1:1). The study participants were recruited and examined at the Leicester Royal Infirmary, United Kingdom, between September 2010 and October 2011 after written informed consent was obtained from participants before commencing the trial. The study was approved by the Leicestershire, Northamptonshire, and Rutland Ethics Committees and adhered to the tenets of the Declaration of
Participant Adherence
Figure 3 illustrates the flow of participants through the study. Of the 24 participants recruited to the study, 4 dropped out. Participant 12 withdrew from the trial because of ill health (not related to the study, and data were collected for the first 2 visits), participant 6 had difficulty inserting the contact lenses (data were collected for the first 2 visits), participant 15 withdrew because of unforeseen family circumstances (data were collected for the first 2 visits), and participant 19
Eye Movement Outcomes
In the first randomized controlled trial comparing the effect of SCL and RGPL wear for those with IN, we find no significant differences in nystagmus intensity between the 2 forms of treatment. We also found no improvement in any nystagmus parameter with contact lens wear compared with the baseline of spectacle wear. This is in contrast to several case reports and case series that observed an improvement in nystagmus with contact lens wear.13, 17, 18, 19, 20 However, these previous reports all
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Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Funded by the College of Optometrists and Ulverscroft Foundation. Contact lenses were provided by Cantor and Nissel Ltd (Brackley, UK) and No 7 Contact Lenses (East Sussex, UK). The sponsor or funding organization had no role in the design or conduct of this research.
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F.A.P. is co first author.