Supramaximal Rectus Recession for Strabismus in Grave's Ophthalmopathy
The Management of Large-angle Strabismus in Grave's Ophthalmopathy With Supramaximal Rectus Recession
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate supramaximal rectus recession for strabismus in Grave's Ophthalmopathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 16, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJune 16, 2021
June 1, 2021
2 years
June 8, 2021
June 15, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Postoperative deviations
Postoperative deviations in the primary position were measured in prism diopters
6 weeks
Postoperative deviations
Postoperative deviations in the primary position were measured in prism diopters
3 months
Postoperative deviations
Postoperative deviations in the primary position were measured in prism diopters
6 months
Secondary Outcomes (9)
binocular single vision
6 weeks
binocular single vision
3 months
binocular single vision
6 months
stereoacuity
6 weeks
stereoacuity
3 months
- +4 more secondary outcomes
Study Arms (2)
supramaximal rectus recession
EXPERIMENTALsupramaximal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy
normal rectus recession
ACTIVE COMPARATORnormal rectus recession to treat large-angle restricted strabismus in thyroid associated ophthalmopathy
Interventions
inferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus
inferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 16, 2021
Study Start
July 1, 2021
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
June 16, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share