EsotropiaNCT00746304
Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
An observational study of Esotropia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia. Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Esotropia
- How many people
- 164 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Dec 2007
- Phase
- Observational
- 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 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: A total of 373 patients with strabismus were treated with botulinum toxin injection by a single surgeon (AH Wang) at the Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan from 1992 to 2005.
Who may be able to join
- infantile esotropia and acquired esotropia
Who cannot join
- exotropia, high AC/A ratio accommodative esotropia, patients with neurological deficit including cerebral palsy, Down syndrome and mental retardation, and ocular anomalies including retinopathy of prematurity. Patients lost to follow-up at 6 months or less after the last injection were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.
Read the detailed description
Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia.
Methods: Patients were injected with botulinum toxin into two medial rectus muscles and followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then yearly post-injection.
Main Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.
- Conditions
- Esotropia
- Keywords
- botulinum, esotropia
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | infantile esotropia | |
| 2 | acquired esotropia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.
Measured: Before treatment, weekly after the treatment, and monthly after motor alignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsotropiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tzu-Hsun Tsai, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746304
- Sponsor's protocol ID
- 200709002R
- Status last verified
- Sep 2007
- First submitted
- 31 Aug 2008
- Last updated
- 3 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
- ClinicalTrials.gov ID
- NCT00746304
- Acronym / sponsor ID
- 200709002R
- Conditions
- Esotropia
- Keywords
- botulinum, esotropia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Sep 2008 (estimated)
- 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.
To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.
Detailed description
Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia.
Methods: Patients were injected with botulinum toxin into two medial rectus muscles and followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then yearly post-injection.
Main Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –infantile esotropia |
| 2 | – | –acquired esotropia |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A total of 373 patients with strabismus were treated with botulinum toxin injection by a single surgeon (AH Wang) at the Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan from 1992 to 2005.
Key inclusion criteria (1 listed)
- infantile esotropia and acquired esotropia
Key exclusion criteria (1 listed)
- exotropia, high AC/A ratio accommodative esotropia, patients with neurological deficit including cerebral palsy, Down syndrome and mental retardation, and ocular anomalies including retinopathy of prematurity. Patients lost to follow-up at 6 months or less after the last injection were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.
Time frame: Before treatment, weekly after the treatment, and monthly after motor alignment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2008.
Related trials for Esotropia
Active, not recruitingObservational study
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Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
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Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
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Visual Therapy for Intermittent Strabismus
Intermittent Strabismus, Exotropia Intermittent
Not yet recruitingPhase 3
A Randomized Trial of Botulinum Toxin A vs Strabismus Surgery for Esotropia >10 to ≤30PD
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.
Tzu-Hsun Tsai, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esotropia, run by National Taiwan University Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 3 Sep 2008. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications. (time frame: Before treatment, weekly after the treatment, and monthly after motor alignment). 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 3 Sep 2008.