An interventional study of BMR resection and BLR recession in Intermittent Exotropia, sponsored by Cairo University. Active, not recruiting at 1 site in Egypt. Open to participants aged 5 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare the efficacy of bilateral lateral rectus recession and bilateral primary medial rectus resection in basic type intermittent exotropia
Participants will be randomized into two groups: bilateral lateral rectus (BLR) recession and bilateral medial rectus (BMR) resection groups then followed up in the clinic for 6 months to compare motor alignment and sensory functions
Study location: Cairo university hospitals
Methodology:
Patients with basic type intermittent exotropia who are indicated to undergo surgical intervention will be grouped into two groups one group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection.
Preoperatively, all patients will be subjected to:
Motor Evaluation:
Patients with near-far disparity >10 prism diopters (PD) will not be included
Sensory Evaluation:
Worth 4 dot test and stereopsis using Random dot test (when possible) The control of exotropia will be assessed using both the newcastle control score
Patients will be randomly assigned to either surgery using simple randomization by random number generator
Intervention:
Postoperative assessment:
Worth 4 dot test and stereopsis will be assessed (when possible)
We are planning a study of the difference in the postoperative angle between the 2 surgical techniques. Assuming a mean difference of 5 PD with a standard deviation of 5 PD, an alpha error of 0.05 and a power of study of 0.8, a total of 17 subjects were found to be needed in each group. Assuming a drop-out rate of 20%, a sample of 20 subjects will be targeted in each group.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Bilateral medial rectus muscle resection
Procedure: BMR resection
Bilateral lateral rectus muscle recession
Procedure: BLR recession
Lid speculum will be applied. Fornix conjunctival incision will be used to expose medial rectus muscle. Area that will be resected will be marked using calipers. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle. The muscle then excised anterior to the sutures and the stump cut flush to the sclera. The muscle will be sutured again to the original insertion by scleral sutures which will be tied together. Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl).
Lid speculum will be applied. Fornix conjunctival incision will be used to expose lateral rectus muscle. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle close to the insertion. The muscle will then be cut anterior to the sutures flush with the sclera. Calipers will used to mark the new insertion on sclera measured from the stump. The muscle will be sutured again to the new insertion by scleral sutures, which will be tied together. Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl).
Motor alignment in primary position
Success rate defined as orthophoria between exotropia/phoria ≤ to 8 prism diopters \& esotropia/phoria ≤ 4 prism diopters
Time frame: 12 months
Palpebral fissure height
Change in palpebral fissure height in mm
Time frame: 12 months
Lateral gaze comitance/incomitance
Difference between angles of deviation in right gaze, primary position, and left gaze
Time frame: 12 months
Stereopsis
Change in stereoacuity in log seconds of arc
Time frame: 12 months
Plan to share: No
Started Jul 2023 (actual). Primary completion is estimated for Nov 2024, 16 months after the start.
Of 29 interventional studies with no phase under Exotropia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 16 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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