Part-time Patch Therapy for Treatment of Intermittent Exotropia

Intermittent Exotropia Clinical Trial

Official title:

A Randomized Clinical Trial of Part-time Patching Therapy on Improvement of Deviation Control in 3 to 8 Year-old Children With Intermittent Exotropia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03700632
• Other study ID #: 9611257005
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 10, 2021

Study information

• Verified date: October 2018
• Source: Tehran University of Medical Sciences
• Contact: Mohammad Mehrpour, MD
• Phone: 00989125011468
• Email: m.mehrpur[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: November 10, 2021
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• Intermittent distance exotropia or constant distance exotropia at least 15? 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.

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

References & Publications (12)

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. — View Citation

Chutter CP. Occlusion treatment of intermittent divergent strabismus. Am Orthopt J. 1977;27:80-4. — View Citation

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. Review. — View Citation

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. — View Citation

IACOBUCCI I, HENDERSON JW. OCCLUSION IN THE PREOPERATIVE TREATMENT OF EXODEVIATIONS. Am Orthopt J. 1965;15:42-7. — View Citation

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

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. Epub 2007 Oct 22. — View Citation

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. — View Citation

Spoor DK, Hiles DA. Occlusion therapy for exodeviations occurring in infants and young children. Ophthalmology. 1979 Dec;86(12):2152-7. — View Citation

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. Epub 2006 Feb 4. — View Citation

Vishnoi SK, Singh V, Mehra MK. Role of occlusion in treatment of intermittent exotropia. Indian J Ophthalmol. 1987 Jul-Aug;35(4):207-10. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Near stereopsis	Stereo acuity is measured at 40 cm using the Titmus test	at the time of enrollment, 3 month later and 6 month later
Secondary	Fusion	fusion at far & near are measured using the Worth 4-dot test. The Worth 4-dot test is used at 50 cm and 6 m for evaluating central and peripheral suppression.	at the time of enrollment, 3 month later and 6 month later