Elsevier

Ophthalmology

Volume 121, Issue 9, September 2014, Pages 1827-1836
Ophthalmology

Original article
A Randomized Controlled Trial Comparing Soft Contact Lens and Rigid Gas-Permeable Lens Wearing in Infantile Nystagmus

Meeting Presentation: Jayaramachandran P, Proudlock FA, Odedra N, Gottlob I, McLean RJ. Optical treatment of nystagmus: a randomised, controlled, cross-over study. ARVO Meeting Abstracts, March 26, 2012, Fort Lauderdale, FL, 53:513. Proudlock FA, Jayaramachandran P, Odedra N, Gottlob I, McLean RJ. Optical treatment of infantile nystagmus. 2nd World Congress of Paediatric Ophthalmology and Strabismus, Milan, Italy, September 8–9, 2012.
https://doi.org/10.1016/j.ophtha.2014.03.007Get rights and content

Objective

To perform the first randomized controlled trial comparing soft contact lens (SCL) with rigid gas-permeable lens (RGPL) wearing in infantile nystagmus (IN), using spectacle wear as a baseline.

Design

Randomized, controlled cross-over trial with an intention-to-treat design.

Participants and Controls

A total of 24 participants with IN (12 idiopathic, 12 with albinism).

Methods

Participants were randomized into 1 of 2 treatment arms receiving the following sequence of treatments (2–3 weeks for each treatment): (A) spectacles, SCL, RGPL, and spectacle wear; or (B) spectacles, RGPL, SCL, and spectacle wear.

Main Outcome Measures

The main outcome measure was mean intensity of nystagmus at the null region viewing at 1.2 m. Secondary outcome measures included the same measure at 0.4 m viewing and across the horizontal meridian (measured over a ±30° range at 3° intervals) for distance and near. The nystagmus foveation characteristics were similarly assessed over ±30° and at the null region at 1.2 m and 0.4 m viewing. Visual outcome measures included best-corrected visual acuity (BCVA) at 4 m and 0.4 m, gaze-dependent visual acuity (GDVA) (i.e., visual acuity when maintaining gaze angles over a ±30° range at 10° intervals) at 4 m, and reading performance at 0.4 m derived from the Radner reading chart.

Results

There were no significant differences between SCL and RGPL wearing for any nystagmus characteristics or compared with spectacle wearing. The BCVA, reading acuity, and critical print size were significantly worse for SCL wearing compared with RGPL and baseline spectacle wear (P<0.05), although mean differences were less than 1 logarithm of the minimum angle of resolution (logMAR) line.

Conclusions

Nystagmus was not significantly different during SCL and RGPL wearing in IN, and contact lens wearing does not significantly reduce nystagmus compared with baseline spectacle wearing. The wearing of SCL leads to a small but statistically significant deterioration in visual function compared with both RGPL and spectacle wearing at baseline, although mean effect sizes were not clinically relevant.

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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    Video and supplemental material are available at www.aaojournal.org

    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.

    F.A.P. is co first author.

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