EsotropiaSETTANCT00993174
Surgery for Esotropia Under Topical Anesthesia
A study testing Topical strabismus surgery and Sub-Tenon's strabismus surgery in people with Esotropia, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Esotropia
- What is being tested?
- Topical strabismus surgery and Sub-Tenon's strabismus surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- May 2004to Jun 2013
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)
- Visual acuity at least 20/40 in each eye
- Cooperation for topical anesthesia
Who cannot join
- Paretic or restrictive strabismus
- Previous eye muscle surgery
- Significant eye disease other than strabismus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amount of Surgery for Esotropia Under Topical Anesthesia
Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.
- Conditions
- Esotropia
- Being tested
- Topical strabismus surgery, Sub-Tenon's strabismus surgery
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical strabismus surgeryProcedure or surgery
Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure
Sub-Tenon's strabismus surgeryProcedure or surgery
Surgery is carried out after sub-Tenon's injection of xylocaine
| Study group | Role | What they receive |
|---|---|---|
| Topical anesthesia | Experimental | Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel) Receives: Procedure: Topical strabismus surgery |
| Sub-Tenon's anesthesia | Active comparator | Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine) Receives: Procedure: Sub-Tenon's strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of surgery required in mm and mm/degree of deviation angle
Measured: Immediate
Secondary outcomes (1)
Motor (deviation angle) and stereoacuity outcome
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 posted12 Oct 2009 (estimated)
- Study startMay 2004
- Primary completionJun 2009
- Study completionJun 2013 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Investigators
- Jaime Tejedor, MD, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993174
- Sponsor's protocol ID
- SETTA
- Acronym
- SETTA
- Status last verified
- May 2010
- First submitted
- 9 Oct 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amount of Surgery for Esotropia Under Topical Anesthesia
- ClinicalTrials.gov ID
- NCT00993174
- Acronym / sponsor ID
- SETTA / SETTA
- Conditions
- Esotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Study start
- May 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 Oct 2009 (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.
Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical anesthesia | Experimental | Procedure: Topical strabismus surgeryPatients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel) |
| Sub-Tenon's anesthesia | Active comparator | Procedure: Sub-Tenon's strabismus surgeryPatients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine) |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)
- Visual acuity at least 20/40 in each eye
- Cooperation for topical anesthesia
Key exclusion criteria (3 listed)
- Paretic or restrictive strabismus
- Previous eye muscle surgery
- Significant eye disease other than strabismus
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 |
|---|---|---|
| Topical strabismus surgerySurgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure | Procedure or surgery | Topical anesthesia |
| Sub-Tenon's strabismus surgerySurgery is carried out after sub-Tenon's injection of xylocaine | Procedure or surgery | Sub-Tenon's anesthesia |
Primary outcome
Amount of surgery required in mm and mm/degree of deviation angle
Time frame: Immediate
1 secondary outcome
Motor (deviation angle) and stereoacuity outcome
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 27 Jun 2011.
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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.
Jaime Tejedor, MD, PhD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical strabismus surgery and Sub-Tenon's strabismus surgery in people with Esotropia, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 3 inclusion and 3 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 27 Jun 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 Spain. 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?
Results are not available in the source record.
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?
Amount of surgery required in mm and mm/degree of deviation angle (time frame: Immediate). 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 27 Jun 2011.