Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia

Intermittent exotropia (IXT) is the most common form of childhood onset exotropia with an
incidence of 32.1 per 100,000 in children under 19 years of age. Intermittent exotropia is
characterized by an exotropia that is not constant and is mainly present when viewing at
distance, but may also be present at near. Normal binocular single vision (BSV) is typically
present at near when the exotropia is controlled, with evidence of normal (occasionally
sub-normal) stereoacuity. Although the natural history of the condition is largely unknown,
many children with IXT are treated using either surgical or non-surgical interventions. The
rationale for intervention in childhood IXT is that extended periods of misalignment may lead
to entrenched suppression, resulting in loss of BSV. Intervention may also aim to address the
social effects caused by the appearance of misaligned eyes. Many children treated for IXT are
currently treated surgically.

There is poor agreement as to which type of surgery is most effective for the correction of
IXT and the debate has long been related to differentiation between IXT sub-types. Based on
distance-near angle disparity, IXT sub-types are classified as: 1) basic (similar magnitude
of misalignment at distance and near); 2) true divergence excess (larger at distance); 3)
pseudo divergence excess (initially larger at distance, but near angle increases following
occlusion or with addition of plus lenses at near); 4) convergence insufficiency (larger at
near). Basic and pseudo divergence excess appear to be the most common of the sub-types, and
are also the types for which there is most disagreement regarding the optimum surgical
approach. The two most common procedures are bilateral lateral rectus recession (BLRrec) and
unilateral lateral rectus recession combined with a medial rectus resection in the same eye
(R&R). Traditionally, BLRrec has been advocated where there is a larger distance angle, and
R&R where there is a similar angle at distance and near. A survey of American strabismus
surgeons published in 1990 found that the majority performed BLRrec for both basic and
divergence excess types. Similarly, we found by polling our investigator group that the
majority still perform a BLRrec for basic type IXT. Nevertheless, controversy still exists as
to which of these surgical approaches is superior. Advocates of the BLRrec procedure tend to
hold that surgery should be based purely on the distance angle of deviation. Proponents of
R&R surgery suggest resection of the medial rectus best addresses the exodeviation at near.

The proposed advantage of the R&R procedure is that resecting the medial rectus, with a
possible longer term initial overcorrection, is necessary for a stable and superior long-term
outcome. Nevertheless, those who favor the BLRrec procedure suggest that the more profound
and prolonged initial overcorrection occurring with R&R is not only unnecessary, but may in
fact be harmful. A persistent overcorrection may be associated with the development of
diplopia, amblyopia, and loss of stereoacuity. On the other hand, critics of the BLRrec
procedure suggest that long-term recurrence rates are higher. Poor motor outcomes are likely
to require reoperation and therefore the long-term success rates of these surgeries have
public health importance in terms of cost to society.

Evaluating initial and long-term surgical outcomes in the proposed randomized clinical trial
(RCT) will answer questions regarding the failure rates of these surgeries and also provide
needed data on the potential harm of each procedure.

Only one prospective randomized clinical trial addresses success rates of BLRrec versus R&R
for IXT. After between 12-15 months of follow up, 82% of 17 patients undergoing an R&R had a
satisfactory outcome compared to 52% of 19 patients undergoing a BLRrec. Nevertheless, there
are some important limitations of this previous study. The sample size was very small. The
study population was a sub-group of patients with basic type IXT, excluding patients with
basic IXT whose angle of deviation increased at far distance or following occlusion, thus
limiting the generalizability of the results. In addition, outcomes were assessed unmasked,
potentially biasing the results. One observational study of 103 patients (90% of whom had
basic type IXT) found 1-year success rates of 56% for BLRrec and 60% for R&R. A retrospective
study of 115 patients with basic type IXT reported success rates of 69% for BLRrec and 77%
for R&R after an average of 15 months of follow up. Other studies comparing surgery types are
limited not only by retrospective study design but also by inclusion of other types of
exotropia, making it difficult to interpret results. In addition, many different criteria for
success are used, precluding meaningful comparison of success rates between studies. This
lack of evidence makes it very difficult to counsel parents of children with IXT regarding
the likely success and complication rate of either procedure, limiting our ability to make
informed management decisions. Establishing the respective failure rates through the proposed
study will allow physicians to offer patients the type of surgery with the highest chance of
long-term success, minimizing suboptimal results and repeat surgeries.

The present study is being conducted to compare the effectiveness of BLRrec with R&R for the
surgical treatment of basic type and pseudo divergence excess type IXT.

Inclusion Criteria:

- Age 3 to < 11 years

- Intermittent exotropia (manifest deviation) meeting all of the following:

- Intermittent exotropia at distance OR constant exotropia at distance and either
intermittent exotropia or exophoria at near

- Largest exodeviation at either distance, near OR remote distance between 15 and
50 prism diopters (PD) (inclusive) by prism and alternate cover test (PACT)

- Exodeviation at least 15 PD at distance and near by PACT

- Basic type or pseudo divergence excess type

- Stereoacuity of 400 arcsec or better at near by Preschool Randot stereotest (better of
2 measures)

- Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on
E-ETDRS)

- No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV
or 10 letters on E-ETDRS testing)

- Absence of high AC/A ratio (exclude > 6:1)

- No previous intraocular surgery, strabismus surgery, or botulinum toxin treatment

- Investigator planning to perform surgery for correction of IXT

- No hyperopia greater than +3.50 D spherical equivalent (SE) in either eye

Exclusion Criteria:

- Coexisting vertical deviation, oblique muscle dysfunction, dissociated vertical
deviation (DVD), or A or V pattern, any of which the investigator plans to address
with vertical transposition of horizontal rectus muscles, oblique surgery, or vertical
rectus muscle surgery, i.e., only small vertical deviations, oblique muscle
dysfunction, DVD, and A or V patterns not requiring surgery are allowed

- Limitation of ocular rotations due to restrictive or paretic strabismus

- Craniofacial malformations affecting the orbits

- Interocular visual acuity difference of more than 0.2 logMAR (2 lines on ATS HOTV for
patients 3 to < 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old)
and/or investigator plans to initiate amblyopia treatment at this time.

- High AC/A ratio (exclude > 6:1 by gradient method)

- Prior strabismus surgery or botulinum toxin injection

- Ocular disorders that would reduce visual acuity (except refractive error)

- Prior intraocular or refractive surgery

- Significant neurological impairment such as cerebral palsy. Patients with mild speech
and/or learning disabilities are eligible.

- Investigator planning to change refractive correction at this time (if the patient is
otherwise eligible, the investigator should consider prescribing refractive correction
and bringing the patient back at a later time for enrollment).