Strabismus, MechanicalNCT04927468
Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy
A study testing supramaximal rectus recession and normal rectus recession in people with Strabismus, Mechanical and Graves Ophthalmopathy, run by Sun Yat-sen University.
Trial summary
The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Strabismus, Mechanical, Graves Ophthalmopathy
- What is being tested?
- supramaximal rectus recession and normal 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
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Jul 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Grave's ophthalmopathy
- angle of deviation more than 20°
- clinically and biochemically euthyroid for at least 3 months;
- a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction
- monocular and mainly single extraocular muscle restricted motility
Who cannot join
- Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid
- best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession
The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy
Read the detailed description
To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy
- Conditions
- Strabismus, Mechanical, Graves Ophthalmopathy
- Being tested
- supramaximal rectus recession, normal rectus recession
- Medical subject headings
- Strabismus, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supramaximal rectus recessionProcedure or surgery
inferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus
normal rectus recessionProcedure or surgery
inferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus
| Study group | Role | What they receive |
|---|---|---|
| supramaximal rectus recession | Experimental | supramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy Receives: Procedure: supramaximal rectus recession |
| normal rectus recession | Active comparator | normal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy Receives: Procedure: normal rectus recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative deviations
Postoperative deviations in the primary position were measured in prism diopters
Measured: 6 weeks
Postoperative deviations
Postoperative deviations in the primary position were measured in prism diopters
Measured: 3 months
Postoperative deviations
Postoperative deviations in the primary position were measured in prism diopters
Measured: 6 months
Secondary outcomes (9)
binocular single vision
measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
Measured: 6 weeks
binocular single vision
measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
Measured: 3 months
binocular single vision
measure the triple visual function including simultaneous vision, fusion range and distance stereoacuity with synoptophore.
Measured: 6 months
stereoacuity
measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
Measured: 6 weeks
stereoacuity
measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
Measured: 3 months
stereoacuity
measure near stereoacuity in downgaze position and distance stereoacuity in primary position with random-dot stereopsis.
Measured: 6 months
ocular motility
evaluate the ocular motility with fixed visual field examination ,scaled from -4 to +4
Measured: 6 weeks
ocular motility
evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4
Measured: 3 months
ocular motility
evaluate the ocular motility with fixed visual field examination,scaled from -4 to +4
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 posted16 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strabismus, MechanicalStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927468
- Sponsor's protocol ID
- yanghs20210607
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 16 Jun 2021
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession
- ClinicalTrials.gov ID
- NCT04927468
- Acronym / sponsor ID
- yanghs20210607
- Conditions
- Strabismus, Mechanical, Graves Ophthalmopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 16 Jun 2021 (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.
The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy
Detailed description
To evaluate the effectiveness and complications of supramaximal rectus recession for large-angle strabismus in Grave's Ophthalmopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supramaximal rectus recession | Experimental | Procedure: supramaximal rectus recessionsupramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy |
| normal rectus recession | Active comparator | Procedure: normal rectus recessionnormal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Grave's ophthalmopathy
- angle of deviation more than 20°
- clinically and biochemically euthyroid for at least 3 months;
- a stable orthoptic examination for at least 3 months, for example no greater than five prism dioptre change in primary position and no greater than an 8° change in duction
- monocular and mainly single extraocular muscle restricted motility
Key exclusion criteria (2 listed)
- Patients with suppression, previously diagnosed and/or treated strabismus not related to the thyroid
- best-corrected visual acuity (BCVA) less than 0.2 in one or both eyes
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 |
|---|---|---|
| supramaximal rectus recessioninferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus | Procedure or surgery | supramaximal rectus recession |
| normal rectus recessioninferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus | Procedure or surgery | normal rectus recession |
Primary outcome
Postoperative deviations
Time frame: 6 weeks
Postoperative deviations in the primary position were measured in prism diopters
Postoperative deviations
Time frame: 3 months
Postoperative deviations in the primary position were measured in prism diopters
Postoperative deviations
Time frame: 6 months
Postoperative deviations in the primary position were measured in prism diopters
9 secondary outcomes
binocular single vision
Time frame: 6 weeks
binocular single vision
Time frame: 3 months
binocular single vision
Time frame: 6 months
stereoacuity
Time frame: 6 weeks
stereoacuity
Time frame: 3 months
stereoacuity
Time frame: 6 months
ocular motility
Time frame: 6 weeks
ocular motility
Time frame: 3 months
ocular motility
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 16 Jun 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing supramaximal rectus recession and normal rectus recession in people with Strabismus, Mechanical and Graves Ophthalmopathy, run by Sun Yat-sen 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 5 inclusion and 2 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 16 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Huasheng (+00862087331539, yanghs64@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative deviations (time frame: 6 weeks). 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?
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 16 Jun 2021.