Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650735
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Bilateral Lateral Rectus Recession Versus Bilateral Primary Medial Rectus Resection in Intermittent Exotropia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Bilateral Lateral Rectus Recession and Bilateral Primary Medial Rectus Resection in Basic Type Intermittent Exotropia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
1 A detailed history taking including presence of asthenopia monocular closure disfigurement or diplopia The previous use of glasses for optical correction use of minus lenses or prior part time occlusion will be documented
2 A detailed ophthalmological examination including uncorrected and best corrected visual acuity whenever possible cycloplegic refraction anterior segment examination and dilated fundus examination
3 Motor Evaluation
Ductions and versions will be done to assess the ocular motility in 9 positions of gaze
The angle of deviation will be measured by the alternate prism cover test for both distance 6 meters and near 33 cm with and without glasses
The angles of misalignment will also be measured in side gazes and in straight up and down gaze whenever possible
In patients with near-far disparity the angle of deviation will be measured again after patching one eye for 30 minutes as well as after putting 3 D lenses in front of each eye
Patients with near-far disparity 10 prism diopters PD will not be included
4 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
One group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection according to the standard tables
All cases will be done under general anaesthesia
Both surgeries take about 30 minutes
Postoperative treatment combined tobramycin 03 and dexamethasone 01 eye drops 3 times daily and the same combination eye ointment at night for 3 weeks
Postoperative follow up will be 1 week 6 weeks 3 months and 6 months minimum follow up
Postoperative assessment
Extraocular movement in lateral gazes will be examined for comitance
Alignment in the primary position will be assessed and any deviation will be measured using alternate prism cover test
Palpebral fissure height will be measured
Worth 4 dot test and stereopsis will be assessed when possible
In cases of failure either over correction or under correction reoperation will be performed after 3 months of the initial surgery
Sample size
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 005 and a power of study of 08 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
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
1 A detailed history taking including presence of asthenopia monocular closure disfigurement or diplopia The previous use of glasses for optical correction use of minus lenses or prior part time occlusion will be documented
2 A detailed ophthalmological examination including uncorrected and best corrected visual acuity whenever possible cycloplegic refraction anterior segment examination and dilated fundus examination
3 Motor Evaluation
Ductions and versions will be done to assess the ocular motility in 9 positions of gaze
The angle of deviation will be measured by the alternate prism cover test for both distance 6 meters and near 33 cm with and without glasses
The angles of misalignment will also be measured in side gazes and in straight up and down gaze whenever possible
In patients with near-far disparity the angle of deviation will be measured again after patching one eye for 30 minutes as well as after putting 3 D lenses in front of each eye
Patients with near-far disparity 10 prism diopters PD will not be included
4 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
One group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection according to the standard tables
All cases will be done under general anaesthesia
Both surgeries take about 30 minutes
Postoperative treatment combined tobramycin 03 and dexamethasone 01 eye drops 3 times daily and the same combination eye ointment at night for 3 weeks
Postoperative follow up will be 1 week 6 weeks 3 months and 6 months minimum follow up
Postoperative assessment
Extraocular movement in lateral gazes will be examined for comitance
Alignment in the primary position will be assessed and any deviation will be measured using alternate prism cover test
Palpebral fissure height will be measured
Worth 4 dot test and stereopsis will be assessed when possible
In cases of failure either over correction or under correction reoperation will be performed after 3 months of the initial surgery
Sample size
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 005 and a power of study of 08 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None