Part-time Patch Therapy for Treatment of Intermittent Exotropia

NCT ID: NCT03700632

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-11-10

Brief Summary

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Intermittent exotropia is the most common type of exotropia in children. Treatment options are surgical and non surgical. Nonsurgical management include Correction of refractive errors, Active orthoptic treatments, Prisms and Occlusion therapy. Benefits of patch therapy are limiting suppression, reducing the frequency and amplitude of the deviation, changing the nature of the deviation (from constant to intermittent exotropia or from intermittent exotropia to exophoria), however, there is a concern that occlusion of the eyes may cause fusion failure and worsen deviation control. According to a few number of studies and controversy among the results of investigations, the investigators designed this randomized clinical trial study to determine the effect of partial patch therapy on the deviation control of children with intermittent exotropia.

Detailed Description

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Conditions

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Intermittent Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the experimental group will be treated with part time patch therapy and control group will be observed without any treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
care provider, investigator and outcome assessor will be unaware the group of participants. because of the nature of study, patch therapy vs no treatment, masking of participant will not be possible.

Study Groups

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patch therapy

The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week.

Group Type EXPERIMENTAL

patch therapy

Intervention Type OTHER

The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week

Control

no intervention will be done

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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patch therapy

The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Intermittent distance exotropia or constant distance exotropia at least 15Δ and intermittent near exotropia or exophoria

Exclusion Criteria

* No child's cooperation in evaluation of deviation control and regular visits for follow-up examinations
* Anisometropia more than 1.50 D, hypermetropia more than 3.50 D, and myopia more than 4.50 D on cyclorefraction
* History of previous treatments including eye occlusion, minus therapy, and strabismus surgery
* Any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Reza Akbari, MD

Role: PRINCIPAL_INVESTIGATOR

Farabi Eye Research Center, Tehran University of Medical Sciences

Central Contacts

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Mohammad Mehrpour, MD

Role: CONTACT

00989125011468

References

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Yu CB, Fan DS, Wong VW, Wong CY, Lam DS. Changing patterns of strabismus: a decade of experience in Hong Kong. Br J Ophthalmol. 2002 Aug;86(8):854-6. doi: 10.1136/bjo.86.8.854.

Reference Type BACKGROUND
PMID: 12140202 (View on PubMed)

Multi-ethnic Pediatric Eye Disease Study Group. Prevalence of amblyopia and strabismus in African American and Hispanic children ages 6 to 72 months the multi-ethnic pediatric eye disease study. Ophthalmology. 2008 Jul;115(7):1229-1236.e1. doi: 10.1016/j.ophtha.2007.08.001. Epub 2007 Oct 22.

Reference Type BACKGROUND
PMID: 17953989 (View on PubMed)

Vishnoi SK, Singh V, Mehra MK. Role of occlusion in treatment of intermittent exotropia. Indian J Ophthalmol. 1987 Jul-Aug;35(4):207-10. No abstract available.

Reference Type BACKGROUND
PMID: 3506931 (View on PubMed)

Pediatric Eye Disease Investigator Group; Cotter SA, Mohney BG, Chandler DL, Holmes JM, Repka MX, Melia M, Wallace DK, Beck RW, Birch EE, Kraker RT, Tamkins SM, Miller AM, Sala NA, Glaser SR. A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. Ophthalmology. 2014 Dec;121(12):2299-310. doi: 10.1016/j.ophtha.2014.07.021. Epub 2014 Sep 16.

Reference Type BACKGROUND
PMID: 25234012 (View on PubMed)

Spoor DK, Hiles DA. Occlusion therapy for exodeviations occurring in infants and young children. Ophthalmology. 1979 Dec;86(12):2152-7. doi: 10.1016/s0161-6420(79)35295-2.

Reference Type BACKGROUND
PMID: 555806 (View on PubMed)

Freeman RS, Isenberg SJ. The use of part-time occlusion for early onset unilateral exotropia. J Pediatr Ophthalmol Strabismus. 1989 Mar-Apr;26(2):94-6. doi: 10.3928/0191-3913-19890301-14.

Reference Type BACKGROUND
PMID: 2709283 (View on PubMed)

Chutter CP. Occlusion treatment of intermittent divergent strabismus. Am Orthopt J. 1977;27:80-4. No abstract available.

Reference Type BACKGROUND
PMID: 900625 (View on PubMed)

IACOBUCCI I, HENDERSON JW. OCCLUSION IN THE PREOPERATIVE TREATMENT OF EXODEVIATIONS. Am Orthopt J. 1965;15:42-7. No abstract available.

Reference Type BACKGROUND
PMID: 14274107 (View on PubMed)

Suh YW, Kim SH, Lee JY, Cho YA. Conversion of intermittent exotropia types subsequent to part-time occlusion therapy and its sustainability. Graefes Arch Clin Exp Ophthalmol. 2006 Jun;244(6):705-8. doi: 10.1007/s00417-005-0195-0. Epub 2006 Feb 4.

Reference Type BACKGROUND
PMID: 16463040 (View on PubMed)

AlKahmous LS, Al-Saleh AA. Does occlusion therapy improve control in intermittent exotropia? Saudi J Ophthalmol. 2016 Oct-Dec;30(4):240-243. doi: 10.1016/j.sjopt.2016.07.004. Epub 2016 Jul 25.

Reference Type BACKGROUND
PMID: 28003783 (View on PubMed)

Coffey B, Wick B, Cotter S, Scharre J, Horner D. Treatment options in intermittent exotropia: a critical appraisal. Optom Vis Sci. 1992 May;69(5):386-404. doi: 10.1097/00006324-199205000-00008.

Reference Type BACKGROUND
PMID: 1594200 (View on PubMed)

Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus. 2006 Sep;14(3):147-50. doi: 10.1080/09273970600894716.

Reference Type BACKGROUND
PMID: 16950743 (View on PubMed)

Akbari MR, Mehrpour M, Mirmohammadsadeghi A. The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2021 Jun;259(6):1625-1633. doi: 10.1007/s00417-020-05065-0. Epub 2021 Jan 7.

Reference Type DERIVED
PMID: 33415357 (View on PubMed)

Other Identifiers

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9611257005

Identifier Type: -

Identifier Source: org_study_id

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