Empirical Versus Trial Set Fitting Systems for
Accelerated Orthokeratology
Carole Maldonado-Codina, PH.D., M.C.OPTOM., F.A.A.O.,
Suzanne Efron, B.SC.(HONS.), M.C.OPTOM.,
Philip Morgan, PH.D., M.C.OPTOM., F.A.A.O.,
Tony Hough, B.A., M.B.A., and Nathan Efron, D.SC., PH.D., M.C.OPTOM.
Purpose. To compare the short-term clinical performance of two
reverse-geometry rigid contact lens systems for accelerated ortho-
keratology with different fitting approaches and designs: an experi-
mental lens that was fitted empirically (No. 7 Contact Lens Labora-
tory, Ltd.) and a more established lens using a trial set system, the BE
lens (NKL). Methods. Twenty-four subjects were enrolled in a
clinical study in which the two reverse-geometry lenses were worn
contralaterally for seven nights. The No. 7 lens was manufactured
based on subject keratometric readings, refraction, and horizontal
visible iris diameter. The BE lens was fitted in accordance with
fitting guidelines provided by the manufacturer and included the
use of proprietary computer software in addition to an overnight
trial before lens ordering. Data were collected at baseline, day 1,
and day 7 (morning and afternoon). Unaided visual acuity, best-
corrected visual acuity, subjective refraction, corneal topography,
biomicroscopy (corneal staining), and subjective reaction were
recorded at each visit. Results. Nine subjects (18 eyes) completed
the study. All eyes fitted with the No. 7 lens and 67% of the eyes
fitted with the BE lens were within 1.00 diopter of the attempted
correction after seven nights of lens wear. There was more myopic
reduction (F = 16.2, P=0.0002), better unaided high-contrast
visual acuity (F = 8.7, P=0.005) and low-contrast visual acuity
(F = 9.5, P=0.003), and more change in corneal numerical
eccentricity (F = 8.6, P=0.005) with the BE lens than with the No.
7 lens. There were no significant differences between the lenses for
best-corrected visual acuity, change in apical radius, corneal stain-
ing, and subjective reaction. Discussion. Both lens types investi-
gated in this study were effective in temporarily reducing myopia
and in providing good unaided visual acuity during the day
(without lenses) in subjects with low levels of myopia. Subjective
reaction showed that the lenses were perceived as being equally
effective, but clinical data showed that the BE lens effected more
myopic reduction and better unaided visual acuity than did the No.
7 lens during the 7-day period investigated.
Key Words: Corneal topography—Empirical—Orthokeratol-
ogy—Reverse-geometry—Rigid gas permeable contact lenses.
Orthokeratology has been defined as the temporary reduction,
modification, or elimination of myopia by the programmed appli-
cation of rigid contact lenses.
1
The developmental history of
orthokeratology from the original Orthofocus technique of Jessen
2
to present-day accelerated orthokeratology has been well docu-
mented elsewhere.
3–5
The renewed interest in orthokeratology in
recent years has been facilitated mainly by advances in lens
materials, manufacturing technology, and corneal topography
measurement systems. The improved oxygen transmissibility of
current-generation reverse-geometry
6,7
lenses, in which the first
back peripheral radius is steeper than the back central optic radius,
allows safe overnight wear and gives patients freedom from lenses
during waking hours. Improvements in manufacturing technology
have allowed more complex lens designs to be fabricated and have
ensured credible and consistent lens parameters. Current video-
keratoscopes allow enhanced measurement of corneal shape versus
standard keratometry, thereby aiding more accurate lens fitting and
improved patient treatment after the fit.
Currently, more than 20 different reverse-geometry lenses have
been purposefully designed for accelerated orthokeratology. These
lenses incorporate different fitting methods, including fitting the
lenses empirically and using trial lenses and accompanying spe-
cialized computer software. This situation makes it potentially
difficult for a practitioner new to orthokeratology to choose which
design will be most successful or suitable. A practitioner may
prefer the design that appears the simplest and easiest to use, but
it is not obvious if this is achieved by empirical fitting, using
diagnostic lenses, or following the guidelines from computer
programs. It may be preferable to select a fitting system that gives
a higher first-fit success rate, even if this system is more compli-
cated. Additionally, the amount of myopic correction obtainable
and how quickly it is achieved are important factors to consider
when choosing a lens. These questions were addressed in a recent
investigation that showed similar efficacy with each of four lens
designs incorporating different fitting philosophies.
8
Although
results such as these are positive for orthokeratology in general,
they make it difficult for a manufacturer wishing to compete in the
orthokeratology market to design a fitting system.
The aim of this investigation was to compare the clinical
performance of two reverse-geometry lens systems consisting of
mutually exclusive integrated fitting approaches and lens designs,
whereby one system was based on an empirically fitted system and
the other system used a system with a trial set. Additionally, it was
This work was sponsored by No. 7 Contact Lens Laboratory, Ltd.
From Eurolens Research (C.M-C., S.E., P.M., N.E.), Department of
Optometry, University of Manchester, Manchester, United Kingdom; and
CLS Software, Ltd. (T.H.), St. Neots, Cambridgeshire, United Kingdom.
Address correspondence and reprint requests to Dr. C. Maldonado-Codina,
Department of Optometry, University of Manchester, PO Box 88, Manchester,
M60 1QD, United Kingdom; e-mail: c.m-codina@manchester.ac.uk
Accepted August 9, 2004.
DOI: 10.1097/01.ICL.0000146170.27288.A3
Eye & Contact Lens 31(4): 137–147, 2005 © 2005 Contact Lens Association of Ophthalmologists, Inc.
137