Partially Accommodative EsotropiaNCT06298929
Medial Rectus Fenestration vs Recession for PAET
A study testing medial rectus fenestration and medial rectus recession in people with Partially Accommodative Esotropia, run by Mansoura University at 1 site in Egypt.
Trial summary
This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Partially Accommodative Esotropia
- What is being tested?
- medial rectus fenestration and medial rectus recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2023to 15 Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.
Who cannot join
- convergence excess esotropia.
- paralytic or restrictive strabismus.
- previous strabismus surgery
- neurologic, ocular, or developmental disorders or follow-up less than 6 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, Gharbia Governorate
Heba M Shafeik, MD, +201227440829, heba.saeid@med.tanta.edu.eg
About this study
Official title: Medial Rectus Muscle Fenestration Versus Medial Rectus Recession for Partially Accommodative Esotropia
This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.
All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration.
Read the detailed description
Inclusion criteria The study will include patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.
Exclusion criteria:
- Patients with convergence excess esotropia, defined as a near deviation with glasses exceeding that for distance by 15 PD or more.
- Patients with paralytic or restrictive strabismus.
- Patients with previous strabismus surgery
- Patients with neurologic, ocular, or developmental disorders or follow-up less than 6 months
All patients will receive complete ophthalmic and orthoptic assessment including:
- 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. ii) Measurement of the deviation at distance (6 m) and near (33 cm). iii) Assessment of ductions and versions in all cardinal directions of gaze
Patients will be randomly allocated using a random table to one of two groups:
- Group 1: Unilateral or bilateral conventional MR recession. Augmented formula will be used to decide the Surgical dosage using the standard tables (3)
- Group 2: unilateral or bilateral MR fenestration All surgeries will be performed by one experienced surgeon (H.SH)
- Conditions
- Partially Accommodative Esotropia
- Being tested
- medial rectus fenestration, medial rectus recession
- Keywords
- esotropia, accommodative, hyperopia, recession, fenestration
- Medical subject headings
- Esotropia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial rectus fenestrationProcedure or surgery
Fenestration technique involves making two splitting incisions by blunt dissection parallel to the muscle fibers on the superior and inferior borders of the muscle, leaving 1 mm of muscle fibers on each edge. The rectangular wide central part is excised from the insertion and between the two splitting incisions to a point back 5-8 mm depending on the angle of the esotropia.
medial rectus recessionProcedure or surgery
recession is one of the gold standard weakening procedures that involves disinsertion of the muscle and re-suturing to the sclera at a more posterior location to decrease its contractile power.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | patients with PAET who will receive unilateral or bilateral MR fenestration Receives: Procedure: medial rectus fenestration |
| Group 2 | Active comparator | patients with PAET who will receive unilateral or bilateral MR recession Receives: Procedure: medial rectus recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular alignment (measured in prism diopters)
The distance and near angles of deviation, with and without glasses, and the angle disparity
Measured: 6 months postoperative
Secondary outcomes (1)
ocular motility
ductions of both eyes (graded on a scale of nine points from -4 to +4)
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Nov 2023
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partially Accommodative EsotropiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Ameera Gamal Abdelhameed, Mansoura University
- Investigators
- Ameera G Abdelhameed, MD, Principal investigator, Assistant professor of ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298929
- Sponsor's protocol ID
- 36264PR427/11/23
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Rectus Muscle Fenestration Versus Medial Rectus Recession for Partially Accommodative Esotropia
- ClinicalTrials.gov ID
- NCT06298929
- Acronym / sponsor ID
- 36264PR427/11/23
- Conditions
- Partially Accommodative Esotropia
- Keywords
- esotropia, accommodative, hyperopia, recession, fenestration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 7 Mar 2024 (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.
This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.
All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration.
Detailed description
Inclusion criteria The study will include patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.
Exclusion criteria:
- Patients with convergence excess esotropia, defined as a near deviation with glasses exceeding that for distance by 15 PD or more.
- Patients with paralytic or restrictive strabismus.
- Patients with previous strabismus surgery
- Patients with neurologic, ocular, or developmental disorders or follow-up less than 6 months
All patients will receive complete ophthalmic and orthoptic assessment including:
- 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. ii) Measurement of the deviation at distance (6 m) and near (33 cm). iii) Assessment of ductions and versions in all cardinal directions of gaze
Patients will be randomly allocated using a random table to one of two groups:
- Group 1: Unilateral or bilateral conventional MR recession. Augmented formula will be used to decide the Surgical dosage using the standard tables (3)
- Group 2: unilateral or bilateral MR fenestration All surgeries will be performed by one experienced surgeon (H.SH)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: medial rectus fenestrationpatients with PAET who will receive unilateral or bilateral MR fenestration |
| Group 2 | Active comparator | Procedure: medial rectus recessionpatients with PAET who will receive unilateral or bilateral MR recession |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.
Key exclusion criteria (4 listed)
- convergence excess esotropia.
- paralytic or restrictive strabismus.
- previous strabismus surgery
- neurologic, ocular, or developmental disorders or follow-up less than 6 months
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 |
|---|---|---|
| medial rectus fenestrationFenestration technique involves making two splitting incisions by blunt dissection parallel to the muscle fibers on the superior and inferior borders of the muscle, leaving 1 mm of muscle fibers on each edge. The rectangular wide central part is excised from the insertion and between the two splitting incisions to a point back 5-8 mm depending on the angle of the esotropia. | Procedure or surgery | Group 1 |
| medial rectus recessionrecession is one of the gold standard weakening procedures that involves disinsertion of the muscle and re-suturing to the sclera at a more posterior location to decrease its contractile power. | Procedure or surgery | Group 2 |
Primary outcome
Ocular alignment (measured in prism diopters)
Time frame: 6 months postoperative
The distance and near angles of deviation, with and without glasses, and the angle disparity
1 secondary outcome
ocular motility
Time frame: 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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.
Ameera G Abdelhameed, MD principal investigator
Assistant professor of ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medial rectus fenestration and medial rectus recession in people with Partially Accommodative Esotropia, run by Mansoura University at 1 site in Egypt.
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 4 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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 Ameera G Abdelhameed, MD (+201120090000, amiragamal287@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular alignment (measured in prism diopters) (time frame: 6 months postoperative). 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 7 Mar 2024.