Cairo University
Cairo, 11562, Egypt
NCT Number: NCT06650735
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
This study is active but is not currently recruiting participants.
Notify Me5 year–30 year
All sexes
Interventional
Not applicable
Cairo, 11562, Egypt
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.
Patients with near-far disparity >10 prism diopters (PD) will not be included
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 12 months
Success rate defined as orthophoria between exotropia/phoria ≤ to 8 prism diopters & esotropia/phoria ≤ 4 prism diopters
Time frame: 12 months
Change in palpebral fissure height in mm
Time frame: 12 months
Difference between angles of deviation in right gaze, primary position, and left gaze
Time frame: 12 months
Change in stereoacuity in log seconds of arc
Cairo University
Other
Comparison Between Bilateral Lateral Rectus Recession and Bilateral Primary Medial Rectus Resection in Basic Type Intermittent Exotropia
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