Surgical Procedure, UnspecifiedNCT04286945
Lateral Rectus Muscle Tendon Elongation
A study testing LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE in people with Surgical Procedure, Unspecified and Ocular Discomfort, run by Tanta University.
Trial summary
To evaluate a technique using resected medial rectus muscle transplantation for elongation of Lateral rectus tendon as a monocular surgery for large angle sensory exotropia. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified, Ocular Discomfort, Strabismus, Divergent
- What is being tested?
- LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD.
Who cannot join
- Patients with exotropia other than sensory type (alternating exotropia, intermittent exotropia)
- Angle of deviation less than 50 PD.
- visual acuity more than 0.2 decimal in affected eye .
- A or V pattern exotropia.
- Nystagmus .
- Refusal of surgery by the adult patients or caregiver of children.
About this study
Official title: Lateral Rectus Muscle Tendon Elongation by an Auto Graft From the Resected Medial Rectus Muscle as a Monocular Surgery for Large Angle Sensory Exotropia
To evaluate a technique using resected medial rectus muscle transplantation for elongation of Lateral rectus tendon as a monocular surgery for large angle sensory exotropia.
Read the detailed description
A prospective study done in Tanta university in the period between January 2017 and June 2018.It included 16 patients with sensory exotropia ≥50PD. Full history was taken. Visual acuity, cycloplegic refraction and fundus exam of both eyes was performed prior to surgery. Strabismus angles were measured at near and distance by alternate prism cover test. Any limitation of adduction or abduction was scaled from -4 to 0. Patients were followed for 6 months.
SURGICAL PROCEDURE:
The MR muscle was dissected through a limbal incision. Two single arm 6-0 Vicryl sutures were placed at desired distance from the insertion as the routine resection of rectus muscle and another pair of 6-0 Vicryl was placed at the insertion. The muscle was then incised from its insertion, and the posteriorly (distally) placed 6-0 Vicryl sutures were passed through the original insertion. The resected segment is then put in saline. A vicryl 6-0 suture was tied at the LR muscle insertion. The muscle was incised from its insertion. Next, the stump of the resected segment was then sutured to the sclera at the desired position measured by the strabismus caliber according to the surgical dosage sufficient to correct the premeasured distant angle (taking into consideration the length of the added segment, which will be added to the amount of recession), and the distal end of this stump was sutured with the proximal end of LR with the 6-0 Vicryl already placed on the LR. Now the elongated muscle was sutured at desired site from the original insertion of LR as done in routine rectus muscle recession.
The patients were followed at 1day after surgery, 2 weeks, 3 month, and 6 months.
In each visit the distant angle of deviation was measured by prism cover test, any limitation of adduction and abduction was scaled, and patient satisfaction with results at last follow up was obtained, all results were recorded and tabulated.
- Being tested
- LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE
- Keywords
- SENSORY EXOTROPIA, LATERAL RECTUS ELONGATION, AUTOGRAFT
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLEProcedure or surgery
Also called Lateral rectus elongation
After resection of the medial rectus muscle, the resected segment is sutured to the lateral rectus muscle after dissection and marking to elongate and slaken the muscle then the elongated muscle is sutured to the sclera at the desired amount of conventional recession.
| Study group | Role | What they receive |
|---|---|---|
| SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES . | Other | Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD, were included in the study. Receives: Procedure: LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant angle of deviation after surgical correction
Measured by alternate prism cover test for near and far,which is considered successful if within10 prism diopter esotropia or exotropia.
Measured: 6month
limitation of adduction and abduction
measured by a scale from -4 to 0; with-4 implying no adduction or abduction beyond midline, -3 implying for 75% deficit,-2 for 50% deficit,-1 for 25% deficit and 0 for full ductions.
Measured: 6month
patient satisfaction with the procedure
score assesed by questionnaire of 3questions based on satisfaction with degree of alignment, aesthetic appearance, limitation of adduction and abduction. 0: I am not satisfied, 1: I am moderately satisfied, 2: I am satisfied, 3: I am very satisfied, and Iwould recommend it to another.
Based on the score (0-3 unsatisfied, 4-6 moderately satisfied, 7-9 very satisfied).
Measured: after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Jan 2017
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PROSPECTIVE STUDY
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Shafik, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286945
- Sponsor's protocol ID
- 21423
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: share data after publication
Publications
Shafik HM, Eldesouky MA, Elbakary MA, Elbedewy HA. Unilateral surgery for pediatric sensory exotropia: clinical characteristics and surgical results. BMC Ophthalmol. 2022 Dec 22;22(1):507. doi: 10.1186/s12886-022-02722-2.
PubMed 36550417
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Rectus Muscle Tendon Elongation by an Auto Graft From the Resected Medial Rectus Muscle as a Monocular Surgery for Large Angle Sensory Exotropia
- ClinicalTrials.gov ID
- NCT04286945
- Acronym / sponsor ID
- 21423
- Keywords
- SENSORY EXOTROPIA, LATERAL RECTUS ELONGATION, AUTOGRAFT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate a technique using resected medial rectus muscle transplantation for elongation of Lateral rectus tendon as a monocular surgery for large angle sensory exotropia.
Detailed description
A prospective study done in Tanta university in the period between January 2017 and June 2018.It included 16 patients with sensory exotropia ≥50PD. Full history was taken. Visual acuity, cycloplegic refraction and fundus exam of both eyes was performed prior to surgery. Strabismus angles were measured at near and distance by alternate prism cover test. Any limitation of adduction or abduction was scaled from -4 to 0. Patients were followed for 6 months.
SURGICAL PROCEDURE:
The MR muscle was dissected through a limbal incision. Two single arm 6-0 Vicryl sutures were placed at desired distance from the insertion as the routine resection of rectus muscle and another pair of 6-0 Vicryl was placed at the insertion. The muscle was then incised from its insertion, and the posteriorly (distally) placed 6-0 Vicryl sutures were passed through the original insertion. The resected segment is then put in saline. A vicryl 6-0 suture was tied at the LR muscle insertion. The muscle was incised from its insertion. Next, the stump of the resected segment was then sutured to the sclera at the desired position measured by the strabismus caliber according to the surgical dosage sufficient to correct the premeasured distant angle (taking into consideration the length of the added segment, which will be added to the amount of recession), and the distal end of this stump was sutured with the proximal end of LR with the 6-0 Vicryl already placed on the LR. Now the elongated muscle was sutured at desired site from the original insertion of LR as done in routine rectus muscle recession.
The patients were followed at 1day after surgery, 2 weeks, 3 month, and 6 months.
In each visit the distant angle of deviation was measured by prism cover test, any limitation of adduction and abduction was scaled, and patient satisfaction with results at last follow up was obtained, all results were recorded and tabulated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PROSPECTIVE STUDY
| Arm | Type | Receives |
|---|---|---|
| SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES . | Other | Procedure: LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLEPatients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD, were included in the study. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with monocular low vision or loss of vision due to congenital or acquired cause with exodeviation of the poorly seeing eye ≥ 50PD.
Key exclusion criteria (6 listed)
- Patients with exotropia other than sensory type (alternating exotropia, intermittent exotropia)
- Angle of deviation less than 50 PD.
- visual acuity more than 0.2 decimal in affected eye .
- A or V pattern exotropia.
- Nystagmus .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLEAlso: Lateral rectus elongationAfter resection of the medial rectus muscle, the resected segment is sutured to the lateral rectus muscle after dissection and marking to elongate and slaken the muscle then the elongated muscle is sutured to the sclera at the desired amount of conventional recession. | Procedure or surgery | SENSORY EXOTROPIA PATIENTS WITH LARGE ANGLES . |
Primary outcome
Distant angle of deviation after surgical correction
Time frame: 6month
Measured by alternate prism cover test for near and far,which is considered successful if within10 prism diopter esotropia or exotropia.
limitation of adduction and abduction
Time frame: 6month
measured by a scale from -4 to 0; with-4 implying no adduction or abduction beyond midline, -3 implying for 75% deficit,-2 for 50% deficit,-1 for 25% deficit and 0 for full ductions.
patient satisfaction with the procedure
Time frame: after 6 month
score assesed by questionnaire of 3questions based on satisfaction with degree of alignment, aesthetic appearance, limitation of adduction and abduction. 0: I am not satisfied, 1: I am moderately satisfied, 2: I am satisfied, 3: I am very satisfied, and Iwould recommend it to another. Based on the score (0-3 unsatisfied, 4-6 moderately satisfied, 7-9 very satisfied).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Derived from this study: PubMed 36550417Shafik HM, Eldesouky MA, Elbakary MA, Elbedewy HA. Unilateral surgery for pediatric sensory exotropia: clinical characteristics and surgical results. BMC Ophthalmol. 2022 Dec 22;22(1):507. doi: 10.1186/s12886-022-02722-2.
- Individual participant dataSharing planned: Yes. share data after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE in people with Surgical Procedure, Unspecified and Ocular Discomfort, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant angle of deviation after surgical correction (time frame: 6month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.