Part-time Patch Therapy for Treatment of Intermittent Exotropia

NCT03700632 | Unknown

• 1 other identifier: 9611257005
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (3)

• 3-point scale Deviation Control

  the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.

  3 months after treatment

• 3-point scale Deviation Control

  the ability of the child to control his/her deviation at far and near was assessed based on an office control 3-point scale : Children are categorized according to the office control 3-point scale into three control groups: good, fair, and poor. Good control: deviation occurs only during covering the eye and fusion is quickly established after removing the cover without blinking and re-fixation. Fair control: deviation occurs only during covering the eye and fusion is established after removing cover by blinking or re-fixation does happen. Poor control: deviation occurs spontaneously without covering and fusion hardly happens with too much effort and after a long time.

  6 months after treatent

• 6-point scale Deviation Control

  the ability of the child to control his/her deviation at far and near was assessed based on the office control 6-point scale: Children are classified according to the office control 6-point scale into six groups of 0 to 5. In this classification, exotropia is ranked after 30 seconds of observation: constant exotropia is ranked 5th, exotropia in more than 50% of the observing time is ranked 4th, and exotropia in less than 50% of the observing time is ranked 3rd. If exotropia is not seen in 30 seconds, the classification is made based on the speed of deviation control and fusion return 10 seconds after covering the eyes: back of fusion in more than 5 seconds is ranked 2nd, fusion return between 1 and 5 seconds ranked 1st, and fusion return in less than 1 second is ranked 0.

  3 months after treatment

Secondary Outcomes (2)

• Near stereopsis

  at the time of enrollment, 3 month later and 6 month later

• Fusion

  at the time of enrollment, 3 month later and 6 month later

Study Arms (2)

patch therapy

EXPERIMENTAL

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.

Other: patch therapy

Control

NO INTERVENTION

no intervention will be done

Interventions

patch therapy 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

patch therapy

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Related Publications (13)

• 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.

  PMID: 12140202 BACKGROUND

• 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.

  PMID: 17953989 BACKGROUND

• 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.

  PMID: 3506931 BACKGROUND

• 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.

  PMID: 25234012 BACKGROUND

• 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.

  PMID: 555806 BACKGROUND

• 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.

  PMID: 2709283 BACKGROUND

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

  PMID: 900625 BACKGROUND

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

  PMID: 14274107 BACKGROUND

• 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.

  PMID: 16463040 BACKGROUND

• 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.

  PMID: 28003783 BACKGROUND

• 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.

  PMID: 1594200 BACKGROUND

• 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.

  PMID: 16950743 BACKGROUND

• 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.

  PMID: 33415357 DERIVED

Study Officials

• Mohammad Reza Akbari, MD

  Farabi Eye Research Center, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Mehrpour, MD

CONTACT

00989125011468; m.mehrpur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the experimental group will be treated with part time patch therapy and control group will be observed without any treatment.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: November 1, 2018
• Primary Completion: May 10, 2020
• Study Completion: November 10, 2021
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share