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Study Title and Description

Selective surgery for intermittent exotropia based on distance/near differences.



Key Questions Addressed
1 What are the interventions for intermittent exotropia?
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Primary Publication Information
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TitleData
Title Selective surgery for intermittent exotropia based on distance/near differences.
Author Kushner BJ.
Country Pediatric Eye & Adult Strabismus Clinic, Department of Ophthalmology & Visual Sciences, University of Wisconsin, Madison, USA. bkushner@facstaff.wisc.edu
Year 1998
Numbers Pubmed ID: 9514485

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Interventions for intermittent exotropia 2013
Arms
Number Title Description Comments
1 Bilateral lateral rectus recession
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2 Unilateral lateral rectus recession unilateral lateral rectus recession with medial rectus resection.
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 324-8
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Methods Randomised trial comparing 2 different surgical interventions for basic X(T).
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Children diagnosed with basic X(T) near deviation within 10 dioptres of distance.
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Interventions Bilateral lateral rectus recession or unilateral lateral rectus recession with medial rectus resection.
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At a minimum of 1 year post surgery (12 to 15 months)
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Satisfactory between 10 dioptres exophoria and 5 dioptres esophoria
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Unsatisfactory any manifest deviation or postoperative treatment.
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Notes 'Control' group also included in study but not reported here as comprises a different subgroup of X(T) all undergoing same surgical procedure.
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Random sequence generation (selection bias):Authors' judgement Low risk
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Random sequence generation (selection bias):Support for judgement The methods used for sequence generation are not described in the manuscript. We contacted the author for further details and clarified that a computer generated random sequence was created.
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Allocation concealment (selection bias):Authors' judgement Low risk
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Allocation concealment (selection bias):Support for judgement It is unclear in the manuscript whether or not there was concealment of treatment allocation. We contacted the author who clarified that the randomisation assignment was put in a series of sequentially numbered sealed envelopes, the contents of which were unknown until after surgery was scheduled and informed consent obtained.
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Blinding (performance bias and detection bias):Authors' judgement High risk
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Blinding (performance bias and detection bias):Support for judgement There was no masking of participants or outcome assessor. Outcomes were assessed by the surgeon who performed surgery.
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Incomplete outcome data (attrition bias):Authors' judgement Low risk
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Incomplete outcome data (attrition bias):Support for judgement 2 participants (1 from each randomised group) were lost to follow up and were therefore excluded from outcome analysis. All other included participants had complete outcome data.
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Selective reporting (reporting bias):Authors' judgement Low risk
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Selective reporting (reporting bias):Support for judgement 99 patients were operated on during the study enrolment period, some of whom were excluded because they were recruited for another study (Kushner 1998b). As it was unclear why or how participants were included in this study rather than the other study, and at what point participants were randomised, we contacted the author for further information: 29 patients were excluded from Kushner 1998a because, according to a predetermined protocol, if they were eligible for the other study (Kushner 1998b) they were automatically selected for recruitment to it. We determined that this did not constitute selective reporting.
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Other bias:Authors' judgement Low risk
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Other bias:Support for judgement Final outcomes were measured 'at least one year' following surgery and varied from 12 to 15 months across the entire study population. Further to communication with the author, we clarified that the follow up was 12 to 15 months for each randomised group. Patients selected for recruitment to this study were those who did not fulfil inclusion criteria for another randomised study running concurrently (Kushner 1998b). Therefore the group who were eligible for inclusion in Kushner 1998a were those whose exodeviation did not increase after patching or while looking outdoors, representing a subset of the entire basic X(T) population. This is not spelled out in the manuscript but has more implications for the generalisability of the results and is not likely to bias conclusions regarding treatment effect.
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Results & Comparisons


Results Data
Outcome: Number of satisfactory results      Population: All Participants
Time Point Measure Bilateral lateral rectus recession Unilateral lateral rectus recession


15 months

N Analyzed 19 17
Satisfactory outcomes 10 (52%) 14 (82%)
Outcome: Number of unsatisfactory results      Population: All Participants
Time Point Measure Bilateral lateral rectus recession Unilateral lateral rectus recession


15 months

N Analyzed 19 17
Satisfactory outcomes 9 (48%) 3 (18%)