Trial Outcomes & Findings for Augmented Medial Rectus Muscle Recession Versus Posterior Scleral Fixation in Partially Accommodative Esotropia (NCT NCT02413463)
NCT ID: NCT02413463
Last Updated: 2019-08-28
Results Overview
Success rate defined as orthotropia or esotropia ≤ 8 prism diopters with the full hypermetropic correction for near and far without changing the preoperative correction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
six months
Results posted on
2019-08-28
Participant Flow
Children with partially accommodative esotropia were recruited from the strabismus clinic of Pediatric Hospital of Cairo University during the period from January 2015 through December 2016. All patients' guardians received a thorough explanation of the study design and aims, and signed a written informed consent.
Participant milestones
| Measure |
Augmented Recession
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Augmented Recession
n=30 Participants
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
n=30 Participants
Medial rectus muscle recession will be performed as described above with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.6 years
STANDARD_DEVIATION 2.6 • n=30 Participants
|
5.2 years
STANDARD_DEVIATION 2.4 • n=30 Participants
|
4.9 years
STANDARD_DEVIATION 2.4 • n=60 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
33 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
27 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Spherical equivalent
|
4.91 Diopters
STANDARD_DEVIATION 1.56 • n=30 Participants
|
4.43 Diopters
STANDARD_DEVIATION 1.74 • n=30 Participants
|
4.67 Diopters
STANDARD_DEVIATION 1.71 • n=60 Participants
|
|
Best-corrected visual acuity
|
0.09 logMAR
STANDARD_DEVIATION 0.06 • n=30 Participants
|
0.11 logMAR
STANDARD_DEVIATION 0.06 • n=30 Participants
|
0.1 logMAR
STANDARD_DEVIATION 0.05 • n=60 Participants
|
|
Amblyopia
|
10 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
22 Participants
n=60 Participants
|
|
Anisometropia
|
11 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
|
Distance angle of deviation with spectacles
|
26 Diopters
STANDARD_DEVIATION 8 • n=30 Participants
|
21 Diopters
STANDARD_DEVIATION 6 • n=30 Participants
|
24 Diopters
STANDARD_DEVIATION 6 • n=60 Participants
|
|
Near angle of deviation with spectacles
|
29 Diopters
STANDARD_DEVIATION 8 • n=30 Participants
|
26 Diopters
STANDARD_DEVIATION 9 • n=30 Participants
|
28 Diopters
STANDARD_DEVIATION 8 • n=60 Participants
|
|
Distance angle of deviation without spectacles
|
47 Diopters
STANDARD_DEVIATION 13 • n=30 Participants
|
43 Diopters
STANDARD_DEVIATION 12 • n=30 Participants
|
45 Diopters
STANDARD_DEVIATION 12 • n=60 Participants
|
|
Near angle of deviation without spectacles
|
50 Diopters
STANDARD_DEVIATION 12 • n=30 Participants
|
50 Diopters
STANDARD_DEVIATION 15 • n=30 Participants
|
50 Diopters
STANDARD_DEVIATION 11 • n=60 Participants
|
|
Angle disparity
|
22 Diopters
STANDARD_DEVIATION 8 • n=30 Participants
|
28 Diopters
STANDARD_DEVIATION 12 • n=30 Participants
|
25 Diopters
STANDARD_DEVIATION 9 • n=60 Participants
|
PRIMARY outcome
Timeframe: six monthsSuccess rate defined as orthotropia or esotropia ≤ 8 prism diopters with the full hypermetropic correction for near and far without changing the preoperative correction.
Outcome measures
| Measure |
Augmented Recession
n=25 Participants
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
n=28 Participants
Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
|---|---|---|
|
Success Rate
|
12 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Six monthsThe angle of deviation after surgery with full hypermetropic correction
Outcome measures
| Measure |
Augmented Recession
n=25 Participants
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
n=28 Participants
Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
|---|---|---|
|
Angle of Deviation With Spectacles for Both Distance and Near
Angle of deviation with spectacles for distance
|
-1 Diopters
Standard Deviation 9
|
-3 Diopters
Standard Deviation 7
|
|
Angle of Deviation With Spectacles for Both Distance and Near
Angle of deviation with spectacles for near
|
2 Diopters
Standard Deviation 9
|
-1 Diopters
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Six monthsThe angle of deviation after surgery without correction for both distance and near
Outcome measures
| Measure |
Augmented Recession
n=25 Participants
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
n=28 Participants
Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
|---|---|---|
|
Angle of Deviation Without Spectacles for Both Distance and Near
Angle of deviation without spectacles for distance
|
2 Diopters
Standard Deviation 9
|
-1 Diopters
Standard Deviation 7
|
|
Angle of Deviation Without Spectacles for Both Distance and Near
Angle of deviation without spectacles for near
|
14 Diopters
Standard Deviation 18
|
6 Diopters
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Six monthsDifference between largest angle and smallest angle
Outcome measures
| Measure |
Augmented Recession
n=25 Participants
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
n=28 Participants
Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
|---|---|---|
|
Angle Disparity
|
15 Diopters
Standard Deviation 3
|
10 Diopters
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Intraoperative timeTime to complete the surgery
Outcome measures
| Measure |
Augmented Recession
n=25 Participants
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
n=28 Participants
Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
|---|---|---|
|
Surgery Time
|
28 Minutes
Standard Deviation 4
|
51 Minutes
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Six monthsNumber of patients who developed intraoperative and postoperative complications as scleral perforation, fat prolapse, slipped and lost muscles
Outcome measures
| Measure |
Augmented Recession
n=25 Participants
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
augmented recession: medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
|
Faden
n=28 Participants
Medial rectus muscle recession will be performed as described as in the augmented recession group with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Faden: medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
|
|---|---|---|
|
Number of Patients Who Developed Intraoperative and/or Postoperative Complications
|
0 Participants
|
0 Participants
|
Adverse Events
Augmented Recession
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Faden
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ahmed Awadein, MD
Faculty of Medicine, Cairo University
Phone: 201223911743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place