An interventional study of patch therapy in Intermittent Exotropia, sponsored by Tehran University of Medical Sciences. Status unknown. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's planned enrollment of 64 is above the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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
no intervention will be done
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after treatment
Near stereopsis
Stereo acuity is measured at 40 cm using the Titmus test
Time frame: at the time of enrollment, 3 month later and 6 month later
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.
Time frame: at the time of enrollment, 3 month later and 6 month later
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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