CLINICAL SCIENCE
Randomized Controlled Study of Ocular Lubrication
Versus Bandage Contact Lens in the Primary Treatment
of Recurrent Corneal Erosion Syndrome
Muhammad A. Ahad, MBBS, FRCS, PhD,*† Maghizh Anandan, MBBS, FRCOphth,* Vikas Tah, MBBS,†
Sumit Dhingra, MBBS, FRCOphth, PhD,† and Martin Leyland, BSc, MB, ChB, MD, FRCOphth*†
Purpose: To investigate the efficacy of bandage contact lenses (BCLs)
in comparison with that of ocular lubricants (OLs) in the initial
management of recurrent corneal erosion syndrome.
Methods: A randomized controlled trial of 29 patients with recurrent
corneal erosion syndrome presenting to the ophthalmol-ogy
departments of the Oxford Eye Hospital and the Royal Berkshire
Hospital, United Kingdom. The patients were random-ized to wear
either BCLs (for a 3-month duration, replaced every 30 days) or use
OLs (4 times a day, with Lacri-Lube ointment at night for 3 months).
The patients were assessed monthly for 4 months, and their symptoms
were graded by visual analog scores. The main outcome measure was
the complete resolution of symptoms with no noticeable corneal surface
abnormality. Patients with a complete resolution were followed up for
another 3 months to check for recurrence.
Results: Fourteen patients were randomized to the BCL arm, and 15
were randomized to the OL arm. After 3 months, a complete resolution
was achieved in 71% of the patients (10/14) with BCLs compared with
that achieved in 73% of the patients (11/15) on OLs (P . 0.05). Partial
resolution was noted in 7% of the patients with BCLs versus 13% of
the patients on OLs. Twenty-one percent of the patients in the BCL
group and 13% of the patients in the OL group failed to respond to the
treatment. Patients on BCLs had earlier resolution of symptoms, with a
mean time of 5 weeks compared with 9 weeks for OLs (P = 0.02). None
of the patients with BCLs developed adverse side effects.
Conclusions: BCLs do not increase the likelihood of complete
resolution when compared with OLs in the initial management of
RCES. However, BCL treatment seems safe, and some patients
experience earlier relief from symptoms.
Key Words: recurrent corneal erosion, bandage contact lens
(Cornea 2013;32:1311–1314)
Received for publication January 25, 2013; revision received May 27, 2013;
accepted May 28, 2013.
From the *Oxford Eye Hospital, Oxford, United Kingdom; and †Department of
Ophthalmology, Royal Berkshire Hospital, Reading, United Kingdom.
The authors have no funding or conflicts of interest to disclose.
Reprints: Muhammad A. Ahad, Oxford Eye Hospital, Headley Way,
Headington, Oxford OX3 9DU, United Kingdom (e-mail:
ahad.muhammad@ gmail.com).
Copyright © 2013 by Lippincott Williams & Wilkins
Cornea Volume 32, Number 10, October 2013
R ecurrent corneal erosion syndrome (RCES) is a relatively
common clinical disorder characterized by repeated epi-sodes of
the breakdown of the corneal epithelium.1 Patients experience
episodes of a sudden onset of pain usually at night or upon waking
up, accompanied by blurred vision, photo-phobia, and watering of
the eyes. Erosions can occur sponta-neously, after a superficial
corneal injury is sustained, in certain corneal dystrophies [such as
epithelial basement mem-brane dystrophy (EBMD) or lattice
dystrophy], and in sys-
temic illnesses such as diabetes.
Abnormal formation of hemidesmosomes or anchoring
filaments at the basal layer of the corneal epithelium is
believed to play an important role in the pathogenesis of
recurrent corneal erosion.2 Bernauer et al3 proposed that the
lids may adhere to the cornea overnight because of the thin-
ning of the tear film. A shearing force on the corneal epithe-
lium may then occur because of the movement of the lid on
waking up or of the eye during rapid eye movement sleep
thus producing corneal erosion.4
Simple medical therapy for recurrent corneal erosion
(prophylaxis or treatment) has been termed “standard therapy”
in some trials. This includes the application of topical oint-
ments, patching of the eye, dilation of the pupil, and adminis-
tration of topical antibiotics, used alone or in combination. 5,6
The effectiveness and safety of this empirical therapy have not
been established in clinical trials. Therapeutic contact lenses or
bandage contact lenses (BCLs) have been used for recalcitrant
recurrent erosion involving the visual axis; the lens may protect
the epithelium from the shearing force of the lids, but it requires
monitoring of the patient for microbial keratitis. 7,8 Williams and
Buckley8 showed that BCLs were inferior to ocular lubricants
(OLs) in abolishing the symptoms of recur-rent erosion and had
a high complication rate. Newer lenses with a higher oxygen
transmission are now available and may have much reduced
complication rates as initially reported.9 Nevertheless, there
exists a small but significant risk of micro-bial keratitis with the
use of extended-wear BCLs.
There is no firm evidence from the trials to suggest the
best initial management and prophylactic regimen in patients
with recurrent corneal erosion. The current clinical practice is to
treat an episode of recurrent corneal erosion with anti-biotics
and lubricating ointments and/or drops, which may be
continued once the episode has resolved to prevent further
episodes of recurrent corneal erosion. Therapeutic contact
lenses may be used if this fails; however, there is no evidence
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Ahad et al
to suggest that BCL treatment is superior to OL treatment in
the primary management of RCES. This study was carried
out to see whether the early usage of a modern BCL in the
treatment of RCES is any better than the use of the standard
lubricant therapy in improving healing and in controlling
symptoms.
METHODS
The study was approved by the local ethics committee
and conformed to the tenets of the Declaration of Helsinki.
Patients presenting to eye clinics in the Royal Berkshire
Hospital, Reading and Oxford Eye Hospital, Oxford (United
Kingdom) were recruited in the study. Patients presenting with
RCES and not having undergone any treatment other than
lubricants or antibiotics in that or previous episodes were
included. Patients with previous episodes who underwent
surgical or laser treatment for RCES were excluded from the
study. Patients with moderate or severe dry eyes, meibomian
gland dysfunction, ocular surface diseases, history of refrac-tive
surgery, or any history of corneal infection or corneal operations
were also excluded from the study. Characteristic symptoms,
history of ocular trauma, and signs of EBMD were employed to
classify patients into 3 categories, namely (1) posttraumatic, (2)
EBMD, and (3) idiopathic.
Idiopathic RCES was defined as the condition in which
patients have classical signs and symptoms with no history
of trauma and no signs of EBMD.
After informed consent was given, all the patients
underwent a complete ocular examination, which included that
for determining the visual acuity; the size and site of erosions;
the presence of microcysts in the epithelium, loose epithelium,
focal basement membrane abnormalities; and the presence of
EBMD. The patients were asked to grade their pain symptoms
using a visual analog score. The patients were then randomized
to either the BCL arm or the OL arm. Randomization was
performed by the random number allocation method, using
SPSS version 13.0. The trial was unmasked because of the
evident nature of BCLs. The patients were followed up for a
total of 7 months. All the patients were examined monthly for 4
months. Those found to have a complete resolution of
symptoms and signs were reviewed for the final time 3 months
later. The patients were asked to keep a record of the number of
episodes of RCES they had suffered in the intervening period.
At each visit, they were asked about the number of
episodes and grading of pain, and then they underwent a slit-
lamp examination. The same clinician who recruited the patient
followed him/her up throughout the whole trial period, thus
eliminating interobserver bias. Patients with macroerosions or
epithelial defects were additionally given chloramphenicol
0.5% eye drops 4 times a day for 5 days and were seen 1 week
later as well. The topical antibiotics were continued till the
epithelial defects were healed and then discontinued.
The patients randomized to OLs used carbomer
(Celluvisc) 0.5% 4 times a day and Lacri-Lube ointment at
night for 3 months. The patients randomized to wear BCLs
were fitted with Air Optix Night and Day lenses (silicone
hydrogel with 24% water; CIBA Vision). The BCLs were
replaced every 30 days for 3 months.
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Cornea Volume 32, Number 10, October 2013
The main outcome measure was the complete resolu-
tion of symptoms after 3 months of treatment. This was
combined with the absence of erosions or loose epithelium
on slit-lamp examination. Trial outcomes were assessed at 4
months, and those with a complete recovery were assessed
again after 3 months.
At 4 months, the subjects were categorized as per the
following conditions:
1. Complete resolution of symptoms with no visible cor-
neal surface abnormality.
2. Partial resolution.
3. No resolution.
“No resolution” was defined as the recurrence of ero-
sions and no change in the frequency or amplitude of symp-
toms during the 3-month trial. “Partial resolution” was
defined as a decrease in the frequency and pain scores com-
bined with either none or fewer ocular surface signs on slit-
lamp examination.
Statistical Methods
Randomization was performed using SPSS version
13.0. Sealed numbered containers were used for allocation
concealment. In the case of bilateral disease, the most
severely affected eye was recruited for the trial, and the
fellow eye was treated as in standard practice. Because
EBMD and posttraumatic RCES have different pathogeneses
and potentially different outcomes, the groups were random-
ized separately to prevent any selection bias.
2
Categorical variables were compared using the x test,
and continuous variables were compared using the t test. A P
value of ,0.05 was considered significant. Priori alpha levels
were set at 0.05, and power was set at 80%. To detect a 30%
difference in the success rate between the 2 groups, a sample
size of 16 in each arm was found to be adequate.
RESULTS
Twenty-nine patients were recruited for the study, and
all completed the trial. They were randomized as shown in
Table 1. The demographic and clinical details of the patients
are shown in Table 2.
Complete Resolution
The result showed that there was no difference in the
main outcome between the 2 treatment arms (Table 3). After
TABLE 1. Categories of Patients With RCES
After Randomization to 2 Treatment Arms
Cause of RCES OLs (N = 15) BCLs (N = 14)
Traumatic 8 7
EBMD 5 6
Idiopathic 2 1
RCES, recurrent corneal erosion syndrome.
2013 Lippincott Williams & Wilkins
Cornea Volume 32, Number 10, October 2013
TABLE 2. Demographic and Clinical Details of Patients
General Features of Patients Range and Ratios
Age range (mean) 21–73 yrs (39 yrs)
Sex ratio, female:male
In traumatic RCES
In dystrophy
Time since the initial trauma, mos, range (mean)
Time since diagnosis with dystrophy, mos, range
(mean, median)
Previous number of RCES episodes treated,
range (mean)
Length of recent symptoms, days, range (mean)
Microerosions noted on the day of recruitment,
no. of patients
Microcysts noted on the day of recruitment, no.
of patients
Macroerosion noted on the day of recruitment,
no. of patients
RCES recurrent corneal erosion syndrome; mos, months.
3 months of the trial and when assessed at 4 months, a com-
plete resolution was achieved in 71.4% of the patients
(10/14) on BCLs compared with that achieved in 73.3%
among pa-tients on OLs, P = 0.61. Subgroup analysis did not
reveal any difference in the resolution rate between the
traumatic and EBMD groups in either treatment arm.
Time to Resolution
The only significant difference between the 2 arms was
seen when comparing the time taken to achieve the
resolution. Patients on BCLs achieved a complete resolution
more quickly, with a mean time of 5 weeks compared with 9
weeks in patients on OLs (P = 0.02).
Relief of Pain
There was an initial trend of better pain scores in the
BCL group compared with that in the OL group (3 vs. 5), but
this difference was not statistically significant and disap-
peared at 2 months. This is shown in detail in Table 4.
The patients who achieved a complete resolution (10
BCLs and 11 OLs) were further followed up till 7 months to
check for recurrences. During this time, the patients were on
prophylactic ointment at nighttime and not on any other
treatment. One patient in each group developed minor
symptoms of RCES with no obvious macroerosions.
TABLE 3. Comparison of Outcome of Patients at 4 Months
Between BCL and OL Arms
Complete Partial
Treatment Resolution, Resolution,
Arm Number (%) Number (%)
BCLs 10 (71) 1 (7)
OLs 11 (73) 2 (13)
2013 Lippincott Williams & Wilkins
Ocular Lubrication Versus Bandage Contact Lens
TABLE 4. Comparison of Mean Pain Scores Between BCL
and OL Treatment Arms
Duration of Treatment BCL Pain Score OL Pain Score P
13:16 At 1 mo 3 5 NS
7:8 At 2 mos 3 3 NS
6:5 At 3 mos 3 2 NS
1–28 (7)
NS, not significant; mo, month.
0–39 (11, 0)
0–5 (2)
None of the patients in the BCL group developed any
3–42 (16) complications. Two patients however felt that the contact
21 lenses were uncomfortable to wear during the first week and
were asked to use lubricating eye drops as and when needed.
25
Both the patients completed the trial, and both achieved a
6
complete resolution.
DISCUSSION
This study was conducted to see whether the use of BCLs
is a safer and better alternative to that of OLs, which is the
standard therapy in the initial management of RCES. We
hypothesized that BCL wear would help avoid the trauma from
rapid eye movement and blinking, thus allowing time for the
defective anchoring system to heal quickly and effectively
compared with the standard lubricant therapy.
BCLs have been studied in the treatment of RCES.
Williams and Buckley8 randomized patients to a conservative
treatment that comprised a topical lubrication group and a BCL
group. Eleven subjects wore a Duragel 75 plano ther-apeutic
contact lens for 8 weeks, and the results showed contact lens
therapy to be inferior to topical lubrication ther-apy with
frequent recurrences and a very high complication rate.
Fraunfelder and Cabezas9 conducted a retrospective study of
BCL use in 12 patients who failed on standard lubri-cating
treatment. They used BCLs (Focus Night & Day) for 3
continuous months with antibiotic cover and lenses replaced
every 2 weeks. Of the 12 patients studied, 9 (75%) had no
recurrence of RCES after approximately 1 year of follow-up.
Three patients had subjective complaints of recurrent erosion
during the follow-up period with one of them having objec-tive
findings of recurrent erosions. They concluded that the 3-month
BCL treatment is a safe and effective medical ther-apy with a
relatively low recurrence rate of RCES.
In our study, the use of BCLs for 3 months compared
with that of OLs alone did not result in improved healing at
the 4-month stage. This is a small-scale study; however,
there was no trend evident to suggest false negative results.
Likewise, there was no significant decrease in pain
scores, but there was a faster resolution of symptoms and
signs. Both methods had an acceptable efficacy, achieving a
complete resolution in .70% of the cases. BCLs in this study
were safe, in contrast to those in the study by Williams and
No Buckley.8 This may reflect better BCL materials with a
Improvement,
Number (%) higher oxygen permeability.10
3 (21)
In this study of the primary management of RCES, 72%
2 (13) of all the patients achieved a complete resolution of signs and
symptoms at 4 months. The patients achieved relief of
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Ahad et al
symptoms faster using BCLs, but there was no difference in
the severity of symptoms and no difference in the likelihood
of resolution between the BCL and OL groups. BCL use
seemed to be safe in this study, but the absence of significant
beneficial effects does not offer support for the routine use of
BCLs in the early management of RCES.
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