Augmented Medial Rectus Muscle Recession Versus Posterior Scleral Fixation in Partially Accommodative Esotropia

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02413463
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

Prospective randomized interventional comparative study

Condition or Disease	Intervention/Treatment	Phase
Partially Accommodative Esotropia	Procedure: augmented recession; Procedure: Faden	N/A

Detailed Description

A prospective controlled interventional study will be performed on patients with partially accommodative esotropia. An informed consent for the surgery will be obtained from all patients. All patients' guardians will receive a thorough explanation of the study design and aims, and sign a written informed consent.

An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ 9. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group will be targeted

All patients will receive a full ophthalmological assessment including history taking, measurement of uncorrected and best-corrected visual acuity, cycloplegic refraction, anterior segment examination, as well as a dilated fundus examination.

In addition, all patients will have a detailed motor examination during the initial evaluation and at each follow-up period. The angle of misalignment will be measured by the prism and alternating cover tests for both distance and near with and without glasses. The angle of horizontal misalignment will also be measured in side gazes and in straight up and down gazes. Measurement of the angle of deviation in up and down gazes will be done by tilting the head, approximately 25 degrees down and up respectively, with the patient fixing on a distance target. The difference between the angles of horizontal misalignment in up and down gazes will be used to calculate the amount of pattern strabismus if present.

The ductions and versions in all cardinal directions of gaze will be analyzed before surgery and thereafter during the postoperative follow up visits. Underaction will be measured on a 4-point scale ranging from -1 to -4. Similarly overaction will be measured on a 4-point scale ranging from +1 to +4.

In all patients cycloplegic refraction will be performed using cyclopentolate 1% eye drops instilled 3 times 10 minutes apart with the last time 30 minutes before refraction. Patients with hypermetropia with a spherical equivalent >= +1.5 D will then prescribed the full cycloplegic refraction and then re-evaluated with spectacles one month later. Patients who appear to have a partially accommodative esotropia defined as residual esotropia >8 PD for distance with spectacles will have repeat refraction using atropine 1% drops 3 times a days for 3 days before refraction.

After ensuring that full cycloplegic refraction was prescribed, patients will then evaluated with glasses to identify those with partially accommodative esotropia without convergence excess. Patients will be included in the study if the residual distance angle with cycloplegic prescription was > 15PD. Patients with convergence excess esotropia, defined as the angle of deviation with glasses for near exceeding that for distance by 15 PD or more will be excluded from the study.

Amblyopia, defined as a difference of 0.3 logMAR in verbal children (3 lines on the standard logMAR visual acuity chart) or a strong unilateral fixation preference using an accommodative target in infants and preverbal children will be treated before surgery following the standard clinical practice using part-time occlusion and in concordance with the PEDIG guidelines.

The smallest angle of deviation will be defined as the corrected angle for distance. The largest angle is defined as the angle for near measured without correction. The angle disparity is defined as the difference between the largest and smallest angles.

Patients were randomly allocated using a random table to one of two groups. In one group bilateral augmented MR muscle recession will be performed (augmented group). In the other group bilateral MR muscle recession combined with posterior scleral fixation sutures will be performed (Faden group).

The surgeries were performed using the same surgical technique. In both groups the medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then secured with 6-0 polyglactin sutures.

In the augmented group, the medial rectus muscles will be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles.

In the Faden group, medial rectus muscle recession will be performed as described above with the surgical dose targeting the smallest pre-operative angle. The muscle will then be 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.

Patients will be followed up at 1 week, 1 month, 3 months and 6 months after surgery. The distance and near angles of deviation, with and without glasses, and the angle disparity were measured at each follow up visit and the ductions and versions will be assessed in all patients.

Patients will be considered to have successful outcome if both the distance and near angles with spectacles were less than 8 PD esotropia/phoria. Patients who develop any exophoria/tropia, or in whom hyperopic correction needed to be reduced for treatment of a consecutive exotropia will be considered to be unsuccessful. In addition, patients will be further subdivided into 2 groups according to the preoperative angle disparity into those with angle disparity 20 PD or less and those with angle disparity more than 20 PD. The success rate in each subgroup was calculated.

For categorical variables (e.g., gender), percent distribution will be used. For continuous variables (e.g. age, angle of deviation), mean, range and standard deviation will be used. Comparisons between the two groups were done using t-test for independent samples for continuous variables and chi square test for categorical variables. Statistical analysis will be performed with SPSS for Windows (SPSS Inc., Chicago, IL).

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Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Augmented Medial Rectus Muscle Recession Versus Medial Rectus Recession With Posterior Scleral Fixation in Partially Accommodative Esotropia
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Procedure: augmented recession; medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
Active Comparator: Faden 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.	Procedure: Faden; medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden); Other Names: Posterior scleral fixation

Outcome Measures

Primary Outcome Measures

1. Success Rate [six months]

   Success rate defined as orthotropia or esotropia ≤ 8 prism diopters with the full hypermetropic correction for near and far without changing the preoperative correction.

Secondary Outcome Measures

1. Angle of Deviation With Spectacles for Both Distance and Near [Six months]

   The angle of deviation after surgery with full hypermetropic correction

2. Angle of Deviation Without Spectacles for Both Distance and Near [Six months]

   The angle of deviation after surgery without correction for both distance and near

3. Angle Disparity [Six months]

   Difference between largest angle and smallest angle

4. Surgery Time [Intraoperative time]

   Time to complete the surgery

5. Number of Patients Who Developed Intraoperative and/or Postoperative Complications [Six months]

   Number of patients who developed intraoperative and postoperative complications as scleral perforation, fat prolapse, slipped and lost muscles

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acquired residual esotropia greater than 14 PD at distance fixation that exists despite full correction of hypermetropic refractive error with the angle of deviation for near not exceeding that of distance by more than 15 PD

• Lack of previous extra ocular muscle surgery

Exclusion Criteria:

• Fully accommodative esotropia, partially accommodative esotropia with convergence excess, non-accommodative esotropia or infantile esotropia

• The presence of neurologic, developmental or ocular structural disorders

• History of previous eye surgery

• Patients requiring simultaneous oblique muscles surgery

• Follow up less than 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Hospital	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Ahmed Awadein, MD, Cairo University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 10, 2015

More Information

Publications

• Wright KW, Bruce-Lyle L. Augmented surgery for esotropia associated with high hypermetropia. J Pediatr Ophthalmol Strabismus. 1993 May-Jun;30(3):167-70.

• Responsible Party: Ahmed Awadein, Professor of Ophthalmology, Cairo University
• ClinicalTrials.gov Identifier: NCT02413463
• Other Study ID Numbers: HHH
• First Posted: Apr 10, 2015
• Last Update Posted: Aug 28, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Esotropia; Strabismus

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Augmented Recession	Faden
Arm/Group Description	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)	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)
Period Title: Overall Study
STARTED	30	30
COMPLETED	25	28
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Augmented Recession	Faden	Total
Arm/Group Description	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)	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 of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.6 (2.6)	5.2 (2.4)	4.9 (2.4)
Sex: Female, Male (Count of Participants)
Female	17 56.7%	16 53.3%	33 55%
Male	13 43.3%	14 46.7%	27 45%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Spherical equivalent (Diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters]	4.91 (1.56)	4.43 (1.74)	4.67 (1.71)
Best-corrected visual acuity (logMAR) [Geometric Mean (Standard Deviation) ]
Geometric Mean (Standard Deviation) [logMAR]	0.09 (0.06)	0.11 (0.06)	0.1 (0.05)
Amblyopia (Count of Participants)
Count of Participants [Participants]	10 33.3%	12 40%	22 36.7%
Anisometropia (Count of Participants)
Count of Participants [Participants]	11 36.7%	13 43.3%	24 40%
Distance angle of deviation with spectacles (Diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters]	26 (8)	21 (6)	24 (6)
Near angle of deviation with spectacles (Diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters]	29 (8)	26 (9)	28 (8)
Distance angle of deviation without spectacles (Diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters]	47 (13)	43 (12)	45 (12)
Near angle of deviation without spectacles (Diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters]	50 (12)	50 (15)	50 (11)
Angle disparity (Diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Diopters]	22 (8)	28 (12)	25 (9)

Outcome Measures

1. Primary Outcome

Title	Success Rate
Description	Success rate defined as orthotropia or esotropia ≤ 8 prism diopters with the full hypermetropic correction for near and far without changing the preoperative correction.
Time Frame	six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Augmented Recession	Faden
Arm/Group Description	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)	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)
Measure Participants	25	28
Count of Participants [Participants]	12 40%	18 60%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Augmented Recession, Faden
	Comments	An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group was targeted
	Type of Statistical Test	Superiority
	Comments	Chi-square test
Statistical Test of Hypothesis	p-Value	0.18
	Comments	This is the calculated p-value for the success rate in the Augmented Group Vs. Faden Group
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Angle of Deviation With Spectacles for Both Distance and Near
Description	The angle of deviation after surgery with full hypermetropic correction
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Augmented Recession	Faden
Arm/Group Description	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)	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)
Measure Participants	25	28
Angle of deviation with spectacles for distance	-1 (9)	-3 (7)
Angle of deviation with spectacles for near	2 (9)	-1 (7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Augmented Recession, Faden
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments	This is the calculated p-value for the postoperative angle of deviation with spectacles for distance in Augmented recession vs. Faden group (First row)
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Angle of Deviation Without Spectacles for Both Distance and Near
Description	The angle of deviation after surgery without correction for both distance and near
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Augmented Recession	Faden
Arm/Group Description	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)	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)
Measure Participants	25	28
Angle of deviation without spectacles for distance	2 (9)	-1 (7)
Angle of deviation without spectacles for near	14 (18)	6 (9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Augmented Recession, Faden
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments	This is the calculated p-value for the postoperative angle of deviation without spectacles for near in Augmented recession vs. Faden group (Second row)
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Angle Disparity
Description	Difference between largest angle and smallest angle
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Augmented Recession	Faden
Arm/Group Description	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)	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)
Measure Participants	25	28
Mean (Standard Deviation) [Diopters]	15 (3)	10 (8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Augmented Recession, Faden
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments	This is the calculated p-value for the postoperative angle disparity in the Augmented Group Vs. Faden Group
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Surgery Time
Description	Time to complete the surgery
Time Frame	Intraoperative time

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Augmented Recession	Faden
Arm/Group Description	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)	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)
Measure Participants	25	28
Mean (Standard Deviation) [Minutes]	28 (4)	51 (7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Augmented Recession, Faden
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	This is the calculated p-value for the intraoperative time in the Augmented Group Vs. Faden Group
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Number of Patients Who Developed Intraoperative and/or Postoperative Complications
Description	Number of patients who developed intraoperative and postoperative complications as scleral perforation, fat prolapse, slipped and lost muscles
Time Frame	Six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Augmented Recession	Faden
Arm/Group Description	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)	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)
Measure Participants	25	28
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	6 months
Arm/Group Title	Augmented Recession		Faden
Arm/Group Description	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)		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)
All Cause Mortality
	Augmented Recession		Faden
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/28 (0%)
Serious Adverse Events
	Augmented Recession		Faden
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Augmented Recession		Faden
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/28 (0%)

Limitations/Caveats

lack of sensory tests and relatively short follow-up

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.