EsotropiaPhase 4NCT01460355
Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone
A Phase 4 study testing Botulinum Toxin Type A and saline solution in people with Esotropia and Exotropia, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- What is being tested?
- Botulinum Toxin Type A and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Jun 2008
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults with large angle horizontal strabismus
Who cannot join
- oblique muscle disfunction
- previous strabismus surgery
- dissociated vertical deviation
- paretic or restrictive deviation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only conventional recess-resect surgery. The patients were randomly located in one of the groups. The angles of horizontal deviation were compared between the groups before and six months after treatment.
Read the detailed description
Patients underwent recess/resection surgery on the non-fixating eye using conventional technique under local anesthesia. The extent of surgery was determined based on our usual amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in 0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.
- Being tested
- Botulinum Toxin Type A, saline solution
- Keywords
- strabismus surgery, botulinum toxin, esotropia, exotropia, blepharoptosis
- Medical subject headings
- Esotropia, Exotropia, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called BTA
injection of 5U in 0.1ml of saline solution will be given to the recessed muscle
saline solutionDrug
Also called saline
injection of 0,1ml of saline solution will be given to the recessed muscle
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin plus surgery | Active comparator | Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery Receives: Drug: Botulinum Toxin Type A |
| Saline solution plus surgery | Placebo comparator | Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of decrease of the initial angle of strabismus
The percentages of decrease of the initial angle of strabismus were accessed by subtracting the final deviation of the initial deviation, dividing the result by the initial deviation and multiplying it by 100.
Measured: 6 to 12 months
Secondary outcomes (1)
frequency of induced blepharoptosis
The presence of induced blepharoptosis was detected by simple inspection and was reported as positive or negative.
Measured: From the first to the last post operative day of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EsotropiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilza Minguini, University of Campinas, Brazil
- Investigators
- Nilza Minguini, MD, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460355
- Sponsor's protocol ID
- Unicamp-CEP- 427/2006
- Status last verified
- Oct 2011
- First submitted
- 16 Oct 2011
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Owens PL, Strominger MB, Rubin PA, Veronneau-Troutman S. Large-angle exotropia corrected by intraoperative botulinum toxin A and monocular recession resection surgery. J AAPOS. 1998 Jun;2(3):144-6. doi: 10.1016/s1091-8531(98)90004-0.
PubMed 10532749Khan AO. Two horizontal rectus eye muscle surgery combined with botulinum toxin for the treatment of very large angle esotropia. A pilot study. Binocul Vis Strabismus Q. 2005;20(1):15-20.
PubMed 15828866Ozkan SB, Topaloglu A, Aydin S. The role of botulinum toxin A in augmentation of the effect of recession and/or resection surgery. J AAPOS. 2006 Apr;10(2):124-7. doi: 10.1016/j.jaapos.2005.11.011.
PubMed 16678746
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Associated to Intraoperative Botulinum Toxin A for Large Angle Horizontal Strabismus: a Pilot Study
- ClinicalTrials.gov ID
- NCT01460355
- Acronym / sponsor ID
- Unicamp-CEP- 427/2006
- Keywords
- strabismus surgery, botulinum toxin, esotropia, exotropia, blepharoptosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 26 Oct 2011 (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.
Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only conventional recess-resect surgery. The patients were randomly located in one of the groups. The angles of horizontal deviation were compared between the groups before and six months after treatment.
Detailed description
Patients underwent recess/resection surgery on the non-fixating eye using conventional technique under local anesthesia. The extent of surgery was determined based on our usual amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in 0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin plus surgery | Active comparator | Drug: Botulinum Toxin Type AIntraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery |
| Saline solution plus surgery | Placebo comparator | Drug: saline solutionSaline solution (0,1 ml)will be given to the recessed muscle during surgery procedure |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adults with large angle horizontal strabismus
Key exclusion criteria (4 listed)
- oblique muscle disfunction
- previous strabismus surgery
- dissociated vertical deviation
- paretic or restrictive deviation
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: BTAinjection of 5U in 0.1ml of saline solution will be given to the recessed muscle | Drug | Botulinum toxin plus surgery |
| saline solutionAlso: salineinjection of 0,1ml of saline solution will be given to the recessed muscle | Drug | Saline solution plus surgery |
Primary outcome
percentage of decrease of the initial angle of strabismus
Time frame: 6 to 12 months
The percentages of decrease of the initial angle of strabismus were accessed by subtracting the final deviation of the initial deviation, dividing the result by the initial deviation and multiplying it by 100.
1 secondary outcome
frequency of induced blepharoptosis
Time frame: From the first to the last post operative day of follow up
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 26 Oct 2011.
- Background: PubMed 10532749Owens PL, Strominger MB, Rubin PA, Veronneau-Troutman S. Large-angle exotropia corrected by intraoperative botulinum toxin A and monocular recession resection surgery. J AAPOS. 1998 Jun;2(3):144-6. doi: 10.1016/s1091-8531(98)90004-0.
- Background: PubMed 15828866Khan AO. Two horizontal rectus eye muscle surgery combined with botulinum toxin for the treatment of very large angle esotropia. A pilot study. Binocul Vis Strabismus Q. 2005;20(1):15-20.
- Background: PubMed 16678746Ozkan SB, Topaloglu A, Aydin S. The role of botulinum toxin A in augmentation of the effect of recession and/or resection surgery. J AAPOS. 2006 Apr;10(2):124-7. doi: 10.1016/j.jaapos.2005.11.011.
- The page shows the summaries of Unicamp Theses on Botulinum ToxinLink provided by the sponsor.
Related trials for Esotropia
Active, not recruitingObservational study
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
Congenital Esotropia
RecruitingObservational study
Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
Volleyball Player
Recruiting
Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
Esotropia
Not yet recruiting
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.
Nilza Minguini, MD, PhD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A and saline solution in people with Esotropia and Exotropia, run by University of Campinas, Brazil at 1 site in Brazil.
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: finished, as of the sponsor's last update on 26 Oct 2011. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
percentage of decrease of the initial angle of strabismus (time frame: 6 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460355, which also lists 3 linked publications.
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 26 Oct 2011.