Horizontal Strabismus With High AC/A RatioPhase 2/3NCT03555045
The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)
A Phase 2/3 study testing conducting the slanted recession technique on the superior and inferior poles and conducting the augmented recession technique on the muscle in people with Horizontal Strabismus With High AC/A Ratio, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Different methods was tried to treat high AC/A strabismus cases;such as prescription of bifocal glasses in esotropia,recession of horizontal muscles with posterior fixation sutures,more recession than needed for far deviation(augmented recession),recession and pulley fixation and slant recession. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Strabismus With High AC/A Ratio
- What is being tested?
- conducting the slanted recession technique on the superior and inferior poles and conducting the augmented recession technique on the muscle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2017to May 2019
- Phase
- Phase 2/3
- 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 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients with horizontal strabismus that the different between far deviation and near deviation is more than 10 pd
Who cannot join
- all patients who had history of surgery on horizontal muscles and patients with pseudo high AC/A ratio.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
zhaleh Rajavi, MD, 9822591616, labbafi@hotmail.com
About this study
Different methods was tried to treat high AC/A strabismus cases;such as prescription of bifocal glasses in esotropia,recession of horizontal muscles with posterior fixation sutures,more recession than needed for far deviation(augmented recession),recession and pulley fixation and slant recession.
Different results was reported for any type of above methods. In recent studies,slanted recession was applied for high AC/A in esotropic cases and success rate of 67% was reported.but there was no unanimity for procedure of choice.
Since slant recession method is simpler and has low side effect than the other methods,therefore in this study the investigators want to peruse the outcome of this method on high AC/A horizontal strabismus.
- Being tested
- conducting the slanted recession technique on the superior and inferior poles, conducting the augmented recession technique on the muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conducting the slanted recession technique on the superior and inferior polesProcedure or surgery
conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.
conducting the augmented recession technique on the muscleProcedure or surgery
conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.
| Study group | Role | What they receive |
|---|---|---|
| conducting the slanted recession technique | Active comparator | conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations. Receives: Procedure: conducting the slanted recession technique on the superior and inferior poles |
| conducting the augmented recession technique on the muscle | Active comparator | conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method. Receives: Procedure: conducting the augmented recession technique on the muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
far-near deviation difference
difference between the far and near deviations
Measured: 90 days after surgery
Secondary outcomes (1)
success rate of surgery
in cases with difference of far and near deviation less than 10 prism diopters
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Feb 2017
- Primary completion1 Jul 2017
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Strabismus With High AC/A RatioStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555045
- Sponsor's protocol ID
- 96302
- Status last verified
- Jan 2018
- First submitted
- 11 Apr 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)
- ClinicalTrials.gov ID
- NCT03555045
- Acronym / sponsor ID
- 96302
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- May 2019 (estimated)
- First posted
- 13 Jun 2018 (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.
Different methods was tried to treat high AC/A strabismus cases;such as prescription of bifocal glasses in esotropia,recession of horizontal muscles with posterior fixation sutures,more recession than needed for far deviation(augmented recession),recession and pulley fixation and slant recession.
Different results was reported for any type of above methods. In recent studies,slanted recession was applied for high AC/A in esotropic cases and success rate of 67% was reported.but there was no unanimity for procedure of choice.
Since slant recession method is simpler and has low side effect than the other methods,therefore in this study the investigators want to peruse the outcome of this method on high AC/A horizontal strabismus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conducting the slanted recession technique | Active comparator | Procedure: conducting the slanted recession technique on the superior and inferior polesconducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations. |
| conducting the augmented recession technique on the muscle | Active comparator | Procedure: conducting the augmented recession technique on the muscleconducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with horizontal strabismus that the different between far deviation and near deviation is more than 10 pd
Key exclusion criteria (1 listed)
- all patients who had history of surgery on horizontal muscles and patients with pseudo high AC/A ratio.
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 |
|---|---|---|
| conducting the slanted recession technique on the superior and inferior polesconducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations. | Procedure or surgery | conducting the slanted recession technique |
| conducting the augmented recession technique on the muscleconducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method. | Procedure or surgery | conducting the augmented recession technique on the muscle |
Primary outcome
far-near deviation difference
Time frame: 90 days after surgery
difference between the far and near deviations
1 secondary outcome
success rate of surgery
Time frame: 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing conducting the slanted recession technique on the superior and inferior poles and conducting the augmented recession technique on the muscle in people with Horizontal Strabismus With High AC/A Ratio, run by Shahid Beheshti University of Medical Sciences at 1 site 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 1 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 13 Jun 2018. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 zhaleh rajavi, MD (9822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
far-near deviation difference (time frame: 90 days after surgery). 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 13 Jun 2018.