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76 Original article

A pilot randomized trial evaluating overminus spectacles versus


part-time occlusion for control of intermittent exotropia among
children 2–10 years of age
Merna G. Abdelfatah, Ahmed T.I Mahmoud, Abdelrahman G. Salman,
Marwa E. Elsebaay
Ophthalmology department, Ain Shams Purpose
university, Cairo, Egypt
The aim was to compare the short-term effectiveness of overminus spectacles
Correspondence to Merna G. Abdelfatah, versus part-time occlusion (PTO) in improving control of intermittent exotropia
MBBCh, 10th Abu bakr el sediq street, [X(T)].
heliopolis, Cairo, 11384, Egypt.
Patients and methods
E-mail: mernagamalahmed@gmail.com
A total of 60 children with X(T), from 2 to 10 years of age, were included in the study.
Received 30 December 2017 Their distance office control score started from 2 or worse. This is a clinical,
Accepted 3 February 2018
randomized, prospective, pilot study. Children were randomly assigned to
Journal of the Egyptian Ophthalmological overminus spectacles, PTO therapy, and observation for 4 months followed by
Society 2018, 111:76–81 2 months without treatment.
Results
The mean distance exotropia control score after 4 months of treatment improved
significantly in the overminus spectacle and the PTO groups from 3.9 vs. 3.9 to 2.0
vs. 2.7, respectively. After stoppage of treatment for 2 months, the score
deteriorated significantly to 3.3 and 3, respectively. The observation group’s
score showed nonsignificant change all throughout the study period.
There was a significant improvement in both mean near and distance angles only in
the overminus spectacle group after 4 months of treatment and a significant
deterioration after 2 months without treatment. Both near and distance angles
showed nonsignificant change in both PTO and observation groups all throughout
the study period. There was also a significant correlation between the poor
compliance of the patients and their deterioration in the PTO group.
Conclusion
Overminus spectacle therapy has proved to be more effective in control of X(T) than
PTO therapy. Poor compliance in PTO therapy affects the treatment effectiveness.
It is suggested to work on a protocol of treatment cessation in further studies.

Keywords:
intermittent exotropia, overcorrecting minus spectacles, part-time occlusion
J Egypt Ophthalmol Soc 111:76–81
© 2018 Journal of the Egyptian Ophthalmological Society
2090-0686

temporary treatment to delay progression of X(T) or


Introduction
to improve the sensory outcome after surgery [7].
Intermittent exotropia [X(T)] is the most common
type of exodeviation in children [1,2]. It is an
Overminus spectacles are additional minus power over
exophoria (X) that intermittently breaks down to a
the cycloplegic refraction, prescribed full time with
constant exotropia (XT) of one or both eyes, mostly
eventual weaning to a point at which the X(T) is
for distance at times of fatigue or inattention [3].
well controlled in the regular refractive correction
Approximately 80% of patients with X(T) will show
[6–8]. They work by stimulating the accommodative
progressive loss of fusional control and an increase in
convergence and thus facilitating fusion [9–11].
the X(T) over several months to years [4].
It has been also reported that part-time occlusion
Although X(T) is a common condition, there is still a
(PTO) therapy has potential benefits in preservation
debate about the efficacy and timing of different
treatment options whether surgical or nonsurgical,
particularly for young children who are not This is an open access journal, and articles are distributed under the terms
of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0
cooperative for accurate measurements [5,6]. License, which allows others to remix, tweak, and build upon the work
Nonsurgical treatment options such as overminus non-commercially, as long as appropriate credit is given and the new
spectacles or occlusion are used as a primary or a creations are licensed under the identical terms.

© 2018 Journal of the Egyptian Ophthalmological Society | Published by Wolters Kluwer - Medknow DOI: 10.4103/ejos.ejos_8_18
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Overminus spectacles versus Part time occlusion for intermittent exotropia Abdelfatah et al 77

of the binocularity and reduction in the frequency or The 20 participants who were assigned to the
magnitude of the exodeviation [12,13]. overminus spectacle group were all prescribed
spectacles with fixed −3.00 D added to the sphere
power of the cycloplegic refraction, which was for all
Patients and methods the waking hours for the whole 4 months, and no other
The study was carried out in the Ophthalmology X(T) treatments were allowed during this time. The
Department, Ain Shams University, according to the cylindrical values were prescribed without changing.
tenets of the Declaration of Helsinki. The protocol
was approved by the Ophthalmology Department and The power of the spectacles was fixed during the 4
Ethical Committee, Ain Shams University. Informed months of treatment and then stopped for 2 months
consents were also given by the parents. with prescription only of nonoverminus refraction
correction if needed.
The study included children from 2 to 10 years with
best-corrected visual acuity not less than 20/100 The treatment regimen for PTO was to cover the eyes
and X(T) meeting the following criteria: (a) distance alternately for 4 h daily whether continuous or
angle at least 20 prism diopters (PD) measured by separated for 4 months and guaranteed that the
prism alternate cover test for cooperative children or by patches were completely closing the eyes so that the
Krimisky test for uncooperative children; (b) near children could not see through them.
deviation should not exceed the distance deviation
by greater than 10 PD; (c) prior treatment for Participants who were assigned to the observation group
X(T) was not permitted preceding enrollment; received no treatment other than nonoverminus
and (d) normal neurological status. Patients with refractive correction if needed.
convergence insufficiency X(T), significant aniso-
metropic amblyopia more than 4 D, and significant Patients were followed-up at the first month, third
vertical deviations or patterns were excluded from our month, and fourth month, and then after stop of
study. treatment at the sixth month. In each visit, we
assessed the fusional control using the Office Control
At the enrollment visit, control of the exodeviation Score and the near and far angles of deviation with and
was assessed at distance (6 m) and near (1/3 m) using without glasses. At each visit, the clinical assessment was
the office control score, which ranges from 0 (X, best performed by a masked examiner.
control) to 5 (XT, worst control). After an initial
control assessment, the magnitude of exodeviation Compliance was assessed for participants in the PTO
was assessed at distance (6 m) whenever possible and and overminus spectacle groups at each follow-up visit.
near (1/3 m). Photographs were taken whenever It was judged to be excellent (>75%), good (51–75%),
possible after the consent of the parents. fair (26–50%), or poor (25%) based on discussions with
Monocular distance best-corrected visual acuity the parent and by reviewing study calendars on which
was measured using Snellen acuity chart for parents recorded the overall number of hours the child
cooperative children, and for younger children, patched or wore the glasses.
visual acuity(VA) was assessed by noticing the
monocular fixation to objects. In addition to the For the PTO group, the child was supposed to cover
clinical testing, the participant’s parents were the eye for 4 h daily, thus, around 480 h in the 4
consulted about the treatment regimen and were months. Any of the parents was asked to the write
instructed to observe the home control of the X down the hours of PTO each day, so we could
(T). All the clinical assessment and prism alternate calculate the percentage and thus judge the child
cover test were performed by study-certified masked compliance.
pediatric ophthalmologists.

Patients were randomly assigned using a permuted Results


block design stratified by mean distance control Between October 2016 and June 2017, 60 children
score with equal probability to overminus spectacles, with X(T) were included in our study. Overall, 55%
PTO, and observation groups. The test results were (33/60) were females and 45% (27/60) were males, and
statistically analyzed to assess the effectiveness of 48.3% (29/60) were myopic and 51.7% (31/60) were
the two treatment modalities versus observation hypermetropic. Moreover, 55% (33/60) of them were
on X(T). younger than 5 years. The demographic statistics are
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78 Journal of the Egyptian Ophthalmological Society, Vol. 111 No. 2, April-June 2018

summarized in Table 1. Most patients (66.66%, 40/60) months of treatment, 90% (18/20) of the patients in
had basic type X(T) and the minority (33.33%, 20/60) the overminus spectacle group showed improvement
had divergence excess X(T). in their control score; 30% (6/20) had one line of
improvement, 60% (12/20) of them showed
Of the 60 participants, 91.6% (55/60) of all the significant improvement, 5% (1/20) showed
participants completed until their fourth month deterioration, and 5% (1/20) showed no change in
follow-up visit. Among them were all the patients in their score. At the sixth-month follow-up after
the observation and overminus spectacle groups stoppage of the overminus spectacles, 88.8% (16/
whereas 75% (15/20) of the patients in the PTO group. 18) of the patients showed deterioration in their
control score, whereas 11% (2/18) remained with
The sixth-month follow-up after treatment stoppage the same score, but no one showed improvement
was completed by 78.3% (47/60). Among them were in the control score after removal of the overminus
70% (14/20) of the patients in the observation group, spectacles.
90% (18/20) of the patients in the overminus spectacle
group, and 75% (15/20) of the patients in the PTO At the fourth-month follow-up, 74% (11/15) in the
group. PTO group showed improvement; among them, 33%
(5/15) showed significant improvement, 20% (3/15)
Sixteen of the 20 (80%) patients in the overminus had the same score before and after treatment, and 6%
spectacle group were judged to have good (1/15) showed deterioration. After 2 months with no
compliance, whereas 27% (4/15) in the PTO therapy PTO therapy, 46.6% (7/15) of the patients showed
group were judged to have good compliance. The P deterioration in their control score. Among them,
value was significant in both groups (P=0.002) as 28.5% (2/7) of them showed poor compliance,
shown in Table 2 and Fig. 1. 28.5% (2/7) showed fair compliance, and 42.8% (3/
7) showed good compliance to the PTO therapy.
Improvement according to Office Control Score was Moreover, 53.4% (8/15) of patients in the PTO
defined as 1-point improvement in the distance group did not show any change in their control
control score, whereas significant improvement was score at the sixth-month visit. Among them, 50%
defined as 2 or more points improvement. After 4 (4/8) showed bad compliance to the treatment and
showed no improvement in the fourth month nor in
the sixth month, 37.5% (3/8) showed fair compliance,
Table 1 Demographic data and mean values of the patients in
the study and only one showed good compliance to the PTO
Descriptive statistics therapy.
Range Mean±SD
Age 2–10 4.675±2.553 Figure 1
SE OD −11–5 −0.728±3.537
SE OS −13.5–5 −0.608±3.608
Pretreatment near angle 15–50 27.717±12.106
Fourth-month near angle 5–50 19.827±12.441
Sixth-month near angle 5–50 22.805±11.729
Pretreatment distance angle 15–70 38.333±12.967
Fourth-month distance angle 10–60 30.240±11.885
Sixth-month distance angle 10–60 34.750±12.957
Pretreatment score 1–5 3.633±1.073
Fourth-month score 1–5 2.491±1.136
Comparison between compliance of patients with overminus specta-
Sixth-month score 1–5 3.085±1.060 cle therapy and part-time occlusion therapy.
SE, spherical equivilant. OD, right eye. OS: left eye.

Table 2 Compliance of patients in both treatment modalities (overminus spectacle vs. part-time occlusion groups)
Compliance Treatment modality [n (%)] χ2 P value
Patching Overminus Total
Poor 6 (40.00) 0 (0.00) 6 (17.14) 12.859 0.002*
Fair 5 (33.33) 4 (20.00) 9 (25.71)
Good 4 (26.67) 16 (80.00) 20 (57.14)
Total 15 (100.00) 20 (100.00) 35 (100.00)
*statistically significant.
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Overminus spectacles versus Part time occlusion for intermittent exotropia Abdelfatah et al 79

In the observation group, 20% (4/20) of the patients 22.7 to 9 PD for near and 39 to 25.1 PD for far. At
showed deterioration in their control score in the the sixth month after 2 months without treatment,
fourth month visit, 45% (9/20) of the patients did there was a significant deterioration to 19.4 PD for
not show any deterioration, and 35% (7/20) of them near and 37.7 PD for far in the overminus group. Both
showed improvement in their score. It was noticed that near and distance angles did not show a significant
most of the children who improved in the observation change in both PTO and observation group all
group were prescribed minus glasses only for their throughout the study period as shown in Figs 3 and 4.
refractive error. Moreover, 92.8% (13/14) showed
the same control score at the sixth month follow-up, When we further studied the compliance of the
and only one patient showed deterioration in the patients who did not improve in the PTO group
control score at the sixth month. after 4 months of treatment, it showed a significant
correlation between the poor compliance of the
The mean distance exotropia control score after 4 patients and their deterioration as shown in Table 4.
months of treatment improved significantly in the
overminus spectacle and the PTO groups to 2.0 and When we further studied the measured angle, which
2.68, respectively, whereas at the sixth month visit after represented the quantitative improvement, and office
the treatment was stopped for 2 months, deteriorated control score, which represented the qualitative
significantly to 3.3 and 3, respectively. The observation improvement, it showed a significant correlation
group’s score showed nonsignificant change all between the angle and the score improvement.
throughout the study period as shown in Fig. 2 and
Table 3.
Discussion
There was a significant improvement in both mean Although nonsurgical treatment for X(T) is still
near and distance angles only in the overminus debatable. It has been reported that approximately
spectacle group after 4 months of treatment from 4–16% of patients improve spontaneously with
observation through the course of time [14,15].
Figure 2 Other clinical investigators have reported a range of
23–75% increase in the angle of deviation through a 5-
year period of follow-up [14,16]. Lee et al. [17]
reported that surgery for deterioration of angle of
deviation to 20 PD or greater is the final destination
of almost half of patients with small exodeviation.
Rowe et al. [10] recommended overminus lens
treatment as a primary treatment option for X(T).
After a comprehensive and systemic review of
the literature, we found no previous prospective
Comparison between office control score in the three groups before randomized trials comparing overminus spectacles
treatment, in the fourth month, and in the sixth month.
and PTO therapy with observation in children with

Table 3 Comparison between Office Control Score in the three groups before treatment, in the fourth month, and in the sixth
month
Scores Observation (mean±SD) Patching (mean±SD) Overminus (mean±SD) ANOVA (F) P value
Pretreatment 3.050±1.099 3.950±1.099 3.950±0.759 5.414 0.007*
Fourth month 2.700±1.342 2.688±1.078 2.000±0.745 2.530 0.089
Sixth month 2.786±1.424 3.067±0.961 3.333±0.767 1.057 0.356
Pr-P4
Differences 0.350±1.182 1.063±1.063 2.000±0.745
Paired test 0.201 0.001* <0.001*
Pr-P6
Differences 0.214±0.893 0.667±0.724 0.611±1.243
Paired test 0.385 0.003* 0.052*
P4-P6
Differences −0.143±0.363 −0.467±0.516 −1.333±1.188
Paired test 0.165 0.004* <0.001*
ANOVA, analysis of variance. *statistically significant.
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80 Journal of the Egyptian Ophthalmological Society, Vol. 111 No. 2, April-June 2018

Figure 3 deteriorated in the sixth month visit after 2 months


with no treatment. In comparison with our study, the
rate of deterioration according to Mohney et al. [18], 6
months after PTO therapy, was 2.2% in 90 patients
from 12 to 35 months of age and in the study by Cotter
et al. [6] was only 0.6% in 159 patients from 3 to 10
years of age. Most patients in the previously mentioned
studies [6,18] showed excellent or good compliance,
which was inconsistent with our study.

Comparison between the mean near angle (pretreatment, at the The mean distance and near angles in the PTO therapy
fourth month, and at the sixth-month follow-up) among the three
groups.
group did not show significant improvement at the
fourth month nor deterioration at the sixth month. In
comparison with our study, Alkhamous and AlSaleh
Figure 4 [13] proved that PTO therapy can improve the
deviation control but does not improve nor worsen
the angle of deviation. However, the assessment
methods were different. Mohney et al. [18] noticed
also no improvement in the angle of deviation despite
improvement in the control and thus proved that there
was not sufficient evidence to prescribe PTO for X(T).
In the overminus spectacle group, 5% of patients
deteriorated in their score whereas 90% showed
Comparison between the mean distance angle (pretreatment, at the improvement at the fourth month of treatment. At
fourth month, and at the sixth-month follow-up) among the three
groups. the sixth month follow-up after stoppage the
overminus spectacles, 88.8% of the patients
Table 4 Correlation between compliance of the patients in
deteriorated in their control score, whereas 11%
overminus spectacle and part-time occlusion groups and remain with the same score, but no one showed
their control score improvement in the control score after removal the
Mean±SD t-Test P value overminus spectacles. There was also a significant
Pretreatment score improvement in the angle for near and far in the
Poor 3.500±1.378 1.782 0.185 overminus spectacle group at the fourth-month
Fair 4.333±0.500 follow-up and a significant deterioration in the
Good 3.750±0.910
sixth-month visit after cessation of treatment.
Fourth-month score
Previous studies of the overminus spectacle therapy
Poor 3.000±1.265 6.110 0.006*
Fair 2.667±0.500
showed variable results and different assessment
Good 1.842±0.765 criteria [10,11,19]. Rowe et al. [10] results were
Sixth-month score based on New Castle Control Score system (NCCS)
Poor 3.333±1.211 0.117 0.890 and showed a 51% improvement rate in 21 patients
Fair 3.111±0.601 after 5 years of follow-up which was longer than the
Good 3.222±0.878 treatment duration in our study and that may explain
*statistically significant. the lower percentage of improvement in his study than
ours. Watts et al. [20] reported a 70.8% success rate in
X(T) in one study. There were also no previous studies 24 patients from 2 to 17 years within 4 months of
that assessed the effect of withdrawal of overminus treatment, which was same as the treatment period in
spectacles for 2 months after 4 months of treatment on our study, with the use of NCCS to assess the control
the control of X(T). Mohney et al. [18] assessed the of X(T). Huseyin et al. [21] retrospective study showed
control of exodeviation at the sixth month after 84% improvement in 19 patients with overminus
cessation of PTO therapy for 1 month following a spectacle therapy. However, with the use of NCCS
5-month treatment period with PTO. and Jampolsky’s assessment criteria in a median of 18
months, the study by Chen et al. [19] showed
The deterioration in the control score after 4 months improvement in the score more than 1 in 59% of
of treatment in our study occurred in 6% of the participants, which is almost similar to our study, as
participants in the PTO group whereas 46% among the 90% who improved were 60% who showed
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Overminus spectacles versus Part time occlusion for intermittent exotropia Abdelfatah et al 81

significant improvement. We both used the same 6 Pediatric Eye Disease Investigator, Cotter SA, Mohney BG, Chandler DL,
Holmes JM, Repka MX, et al. A randomized trial comparing part-time
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Financial support and sponsorship intermitent exotropia? SJOPT 2016; 433:1–4.
Nil. 14 Berg PH, Isenberg SJ. Treatment of unilateral exotropia by part-time
occlusion. Am Orthopt J 1991; 41:72–76.
Conflicts of interest 15 Berg PH, Lozano MJ, Isenberg SJ. Long-term results of parttime occlusion
for intermittent exotropia. Am Orthopt J 1998; 48:85–89.
There are no conflicts of interest.
16 Chutter CP. Occlusion treatment of intermittent divergent strabismus. Am
Orthopt J 1977; 27:80–84.
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