StrabismusNCT04213768
Lateral Rectus Resection Versus Lateral Rectus Plication in Patients With Residual Esotropia
A study testing Lateral rectus plication and Lateral rectus Resection in people with Strabismus, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
Trial summary
In this study, the surgical outcomes of lateral rectus plication and resection techniques on patients with residual esotropia will be compared. Methods: In this randomized clinical trial, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection are going… Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Strabismus
- What is being tested?
- Lateral rectus plication and Lateral rectus Resection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesIran
- Study dates
- Dec 2019to Jun 2020
- 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 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- residual esotropia after any strabismus surgery
Who cannot join
- Subjects with a history of prematurity
- lack of central fixation
- extraocular muscle palsy
- systemic disorders
- ocular disorders
- follow up less than three months
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Hamideh Sabbaghi
Tehran
Hamideh Sabbaghi
Islamic Republic of Iran
Tehran
Hamideh Sabbaghi, MS, +989120285930, sabbaghi_h@yahoo.com
About this study
Official title: LR Resection Versus Plication in Esotropia
In this study, the surgical outcomes of lateral rectus plication and resection techniques on patients with residual esotropia will be compared.
Methods: In this randomized clinical trial, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection are going to be included and randomized into plication and resection groups. The inclusion criteria will be residual esotropia after uni- or bilateral medial rectus recession, or unilateral recession and resection (R\&R). Subjects with a history of prematurity, lack of central fixation, extraocular muscle palsy, systemic, ocular disorders, follow up less than three months will be excluded. A comprehensive ophthalmic examinations are going to be conducted preoperatively and at 1, 3 and 6 months' follow-ups. Surgical success rate will be considered in cases with a postoperative eso- or exotropia ≤10pd.
Read the detailed description
In this clinical trial study, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection will be included and randomized into plication (n=27) and resection (n=30) groups.
An informed consent will be obtained from all patients or their parents after explanation of the two techniques and their possible advantages and disadvantages. The study protocol will be approved by the Ethics Committee of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and it adheres to tenets of the Declaration of Helsinki.
The inclusion criteria will be the presence of residual esotropia ≥15pd after uni- or bilateral medial rectus recession. Subjects with a history of prematurity, intellectual disability, lack of central fixation (nystagmus, eccentric fixation, retinopathy of prematurity), extraocular muscle palsy, systemic, ocular, and neurological disorders, or follow- up less than three months will be excluded from this study. The surgeon who performed surgeries will not be masked, while the personnel who conducted data gathering and postoperative examinations will be blind to the group assignments.
Visual and Ocular Examinations Comprehensive ophthalmic examination including cyclorefraction (45 minutes after installation of one drop tropicamide 1% and cyclopentolate 1%), best corrected visual acuity (BCVA), extraocular muscle motility (version and duction from -4 to +4) will be performed, the ocular deviation will be measured at both far (6m) and near (33cm) distances using an alternate prism cover test or Krimsky method. A- or V- ocular pattern will be also determined if the difference of deviation was more than 10 or 15pd at 30 degrees between superior and inferior of primary position, respectively. Stereopsis will be measured using a Titmus test. According to the patients' response, stereopsis was also classified in to three groups of central (≤100 sec/arc), peripheral (100 to 3000 sec/arc) and suppression (≥3000). Ocular anterior and posterior segments will be examined using slit lamp and indirect ophthalmoscopy. Eligible patients will be randomly divided to lateral rectus plication (case) and lateral rectus resection (control) groups and the amount of operation will be according to the Park's table in the both groups. In patients with residual esotropia less than 20pd, unilateral lateral rectus recession and in patients with residual esotropia more than 20pd, bilateral lateral rectus recession will be considered. All examinations will be repeated at one, three and six month follow-ups. Surgical success rate will be considered in patients with a postoperative deviation ≤10pd.
- Conditions
- Strabismus
- Being tested
- Lateral rectus plication, Lateral rectus Resection
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral rectus plicationProcedure or surgery
The technique is the same as resection up to the muscle suturing, in the next step, the sutures is passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle is folded anteriorly by Stevens muscle hook during tightening and fixing the sutures. At the end, conjunctiva is repaired by Vicryl 8-0.
Lateral rectus ResectionProcedure or surgery
Following conjunctiva and tendon capsule incision, lateral rectus is hooked and dissected from its surrounding tissues. Then, the muscle is sutured according to the amount of supposed resection from lateral rectus insertion by Vicryl 6-0 (polyglation 910, coated Vicryl®, Ethicon, Blue Ash, OH). Afterwards, the muscle is cut at 1mm anterior to these sutures and the residual muscle is re-sutured to the sclera at its primary insertion. Finally the conjunctiva is repaired using Vicryl 8-0.
| Study group | Role | What they receive |
|---|---|---|
| Plication | Experimental | Not described Receives: Procedure: Lateral rectus plication |
| Resection | Active comparator | Not described Receives: Procedure: Lateral rectus Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative angle of deviation measured by alternative prism cover test based on prism diopter unit
Measured: 6 months
Secondary outcomes (1)
Postoperative exodrift
Exodrift can be achieved by the change of the post- and preoperative angle of deviation measured by alternative prism cover test at far distance and recorded based on prism diopter unit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamideh Sabbaghi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213768
- Sponsor's protocol ID
- IR.SBMU.ORC.REC.1398.022
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LR Resection Versus Plication in Esotropia
- ClinicalTrials.gov ID
- NCT04213768
- Acronym / sponsor ID
- IR.SBMU.ORC.REC.1398.022
- Conditions
- Strabismus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 Dec 2019 (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.
In this study, the surgical outcomes of lateral rectus plication and resection techniques on patients with residual esotropia will be compared.
Methods: In this randomized clinical trial, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection are going to be included and randomized into plication and resection groups. The inclusion criteria will be residual esotropia after uni- or bilateral medial rectus recession, or unilateral recession and resection (R\&R). Subjects with a history of prematurity, lack of central fixation, extraocular muscle palsy, systemic, ocular disorders, follow up less than three months will be excluded. A comprehensive ophthalmic examinations are going to be conducted preoperatively and at 1, 3 and 6 months' follow-ups. Surgical success rate will be considered in cases with a postoperative eso- or exotropia ≤10pd.
Detailed description
In this clinical trial study, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection will be included and randomized into plication (n=27) and resection (n=30) groups.
An informed consent will be obtained from all patients or their parents after explanation of the two techniques and their possible advantages and disadvantages. The study protocol will be approved by the Ethics Committee of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and it adheres to tenets of the Declaration of Helsinki.
The inclusion criteria will be the presence of residual esotropia ≥15pd after uni- or bilateral medial rectus recession. Subjects with a history of prematurity, intellectual disability, lack of central fixation (nystagmus, eccentric fixation, retinopathy of prematurity), extraocular muscle palsy, systemic, ocular, and neurological disorders, or follow- up less than three months will be excluded from this study. The surgeon who performed surgeries will not be masked, while the personnel who conducted data gathering and postoperative examinations will be blind to the group assignments.
Visual and Ocular Examinations Comprehensive ophthalmic examination including cyclorefraction (45 minutes after installation of one drop tropicamide 1% and cyclopentolate 1%), best corrected visual acuity (BCVA), extraocular muscle motility (version and duction from -4 to +4) will be performed, the ocular deviation will be measured at both far (6m) and near (33cm) distances using an alternate prism cover test or Krimsky method. A- or V- ocular pattern will be also determined if the difference of deviation was more than 10 or 15pd at 30 degrees between superior and inferior of primary position, respectively. Stereopsis will be measured using a Titmus test. According to the patients' response, stereopsis was also classified in to three groups of central (≤100 sec/arc), peripheral (100 to 3000 sec/arc) and suppression (≥3000). Ocular anterior and posterior segments will be examined using slit lamp and indirect ophthalmoscopy. Eligible patients will be randomly divided to lateral rectus plication (case) and lateral rectus resection (control) groups and the amount of operation will be according to the Park's table in the both groups. In patients with residual esotropia less than 20pd, unilateral lateral rectus recession and in patients with residual esotropia more than 20pd, bilateral lateral rectus recession will be considered. All examinations will be repeated at one, three and six month follow-ups. Surgical success rate will be considered in patients with a postoperative deviation ≤10pd.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plication | Experimental | Procedure: Lateral rectus plication |
| Resection | Active comparator | Procedure: Lateral rectus Resection |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- residual esotropia after any strabismus surgery
Key exclusion criteria (6 listed)
- Subjects with a history of prematurity
- lack of central fixation
- extraocular muscle palsy
- systemic disorders
- ocular disorders
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 plicationThe technique is the same as resection up to the muscle suturing, in the next step, the sutures is passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle is folded anteriorly by Stevens muscle hook during tightening and fixing the sutures. At the end, conjunctiva is repaired by Vicryl 8-0. | Procedure or surgery | Plication |
| Lateral rectus ResectionFollowing conjunctiva and tendon capsule incision, lateral rectus is hooked and dissected from its surrounding tissues. Then, the muscle is sutured according to the amount of supposed resection from lateral rectus insertion by Vicryl 6-0 (polyglation 910, coated Vicryl®, Ethicon, Blue Ash, OH). Afterwards, the muscle is cut at 1mm anterior to these sutures and the residual muscle is re-sutured to the sclera at its primary insertion. Finally the conjunctiva is repaired using Vicryl 8-0. | Procedure or surgery | Resection |
Primary outcome
Postoperative angle of deviation measured by alternative prism cover test based on prism diopter unit
Time frame: 6 months
1 secondary outcome
Postoperative exodrift
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Strabismus
Not yet recruiting
Comparative Study Of Combined Recession-Resection And Fenestration of Superior Rectus Muscle for Treatment of Dissociated Vertical Deviation
Dissociated Vertical Deviation
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
RecruitingObservational study
Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
Volleyball Player
Recruiting
Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
Esotropia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral rectus plication and Lateral rectus Resection in people with Strabismus, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
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: status not confirmed, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamideh Sabbaghi, PhD (989120285930, sabbaghi.opt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative angle of deviation measured by alternative prism cover test based on prism diopter unit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2019.