Evidence map›Paper›PMID 26072346›Full record

Trial reportOphthalmology2015

A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age.

Pediatric Eye Disease Investigator Group, Brian G Mohney, Susan A Cotter, Danielle L Chandler, Jonathan M Holmes, Angela M Chen, Michele Melia, Sean P Donahue, David K Wallace, Raymond T Kraker and 2 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01032330 (A Randomized Clinical Trial of Observation Versus Occlusion Therapy for Intermittent Exotropia), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01032330 nacompletednot on this map

A Randomized Clinical Trial of Observation Versus Occlusion Therapy for Intermittent Exotropia

TypeinterventionalSponsorJaeb Center for Health ResearchRan2010 to 2015Enrolled611ConditionsExotropiaArmsocclusion treatment
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Interventions for intermittent exotropia.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
    Trial
  9. Three-year observation of children 12 to 35 months old with untreated intermittent exotropia.Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) · 2020
    Trial
  10. Relationship among clinical factors in childhood intermittent exotropia.Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus · 2017
    Trial
  11. Review
  12. Article
  13. Article
  14. Article
  15. Quality of life in adult intermittent exotropia and the risk factors.International journal of ophthalmology · 2021
    Article
  16. Article
  17. Review
  18. Review
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Pediatric Eye Disease Investigator Group
Brian G MohneyDepartment of Ophthalmology, Mayo Clinic, Rochester, Minnesota. Electronic address: pedig@jaeb.org.
Susan A CotterSouthern California College of Optometry at Marshall B. Ketchum University, Fullerton, California.
Danielle L ChandlerJaeb Center for Health Research, Tampa, Florida.
Jonathan M HolmesDepartment of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
Angela M ChenSouthern California College of Optometry at Marshall B. Ketchum University, Fullerton, California.
Michele MeliaJaeb Center for Health Research, Tampa, Florida.
Sean P DonahueVanderbilt Eye Center, Nashville, Tennessee.
David K WallaceDuke Eye Center, Durham, North Carolina.
Raymond T KrakerJaeb Center for Health Research, Tampa, Florida.
Melanie L ChristianConcord Ophthalmologic Associates, Concord, Ohio.
Donny W SuhWolfe Clinic, West Des Moines, Iowa.
Jaeb Center for Health Research · USMarshall B. Ketchum University · USMayo Clinic · USVanderbilt Health · USWolfe Eye Clinic · US

Funding

Pediatric Eye Disease Investigator Group Coordinating CenterU10EY011751 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI KRAKER, RAYMOND · 1997 to 2018
$75.2M
Pediatric Eye Disease Investigator Group NetworkUG1EY011751 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI Raymond Kraker, Stacy Pineles · 2019 to 2026
$53.7M
Pediatric Eye Disease Investigator Group: Chair's OfficeU10EY018810 · NEI · MAYO CLINIC ROCHESTER · PI HOLMES, JONATHAN M · 2009 to 2013
$3.5M
NEI NIH HHS EY011751NEI NIH HHS EY018810NEI NIH HHS U10 EY011751NEI NIH HHS U10 EY018810NEI NIH HHS UG1 EY011751
6 · The paper itself

Abstract

purposeTo determine the effectiveness of part-time patching for treating intermittent exotropia (IXT) in young children.

designMulticenter, randomized clinical trial.

participantsTwo hundred one children 12 to 35 months of age with untreated IXT meeting the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near, and (2) 15-prism diopter (Δ) or more exodeviation at distance or near by prism and alternate cover test (PACT) but at least 10 Δ exodeviation at distance by PACT.

methodsParticipants were assigned randomly to either observation (no treatment for 6 months) or patching prescribed for 3 hours daily for 5 months, followed by 1 month of no patching.

main outcome measuresThe primary outcome was deterioration, defined as constant exotropia measuring at least 10 Δ at distance and near or receipt of nonprotocol treatment for IXT.

resultsOf the 177 participants (88%) completing the 6-month primary outcome examination, deterioration occurred in 4.6% (4 of 87) of the participants in the observation group and in 2.2% (2 of 90) of the participants in the patching group (difference, 2.4%; P = 0.27; 95% confidence interval, -3.8% to +9.4%). Motor deterioration occurred in 2.3% (2 of 87) of the observation group and in 2.2% (2 of 90) of the patching group (difference, 0.08%; P = 0.55; 95% confidence interval, -5.8% to +6.1%). For the observation and patching groups, respectively, 6-month mean PACT measurements were 27.9 Δ versus 24.9 Δ at distance (P = 0.02) and 19.3 Δ versus 17.0 Δ at near (P = 0.10); 6-month mean exotropia control scores were 2.8 versus 2.3 points at distance (P = 0.02) and 1.4 versus 1.1 points at near (P = 0.26).

conclusionsAmong children 12 to 35 months of age with previously untreated IXT, deterioration over 6 months was uncommon, with or without patching treatment. There was insufficient evidence to recommend part-time patching for the treatment of IXT in children in this age group.

Indexed as

BandagesEye Protective DevicesChild, PreschoolExotropiaFemaleFollow-Up StudiesHumansInfantMaleObservationPrognosis

Identifiers

PMID26072346
PMCPMC4516562
OpenAlexW1602955971

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.