|- candidate number||14759|
|- NTR Number||NTR3959|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-apr-2013|
|- Secondary IDs||NL42631.078.12 MEC-2012-564 / OZR-2012-07|
|- Public Title||An alternative approach for treatment of infantile esotropia with botulinum toxin A.
|- Scientific Title||An alternative approach for treatment of infantile esotropia with botulinum toxin A.
|- hypothesis||The proportion of successful alignment after treatment of infantile esotropia with Botox is not inferior to conventional strabism surgery.|
|- Healt Condition(s) or Problem(s) studied||Infantile esotropia|
|- Inclusion criteria||1. No known/established neurological disease;|
2. History of orthotropia;
3. No vertical deviation (no upshoots);
4. Non-accommodative (less than 3D spherical equivalent hyperopia);
5. Up to 40 ∆ esotropia;
6. Free alternators;
7. Difference in refraction between both eyes ≤ 1.5 D.
|- Exclusion criteria||1. Previous strabismus surgery;|
2. Retinal disease;
3. Any medical condition that would preclude general anesthesia with sevoflurane;
4. Hypersensitivity to any Botox ingredient;
5. Muscular disease such as myasthenia gravis or Eaton-Lambert syndrome.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2013|
|- planned closingdate||31-mrt-2016|
|- Target number of participants||40|
|- Interventions||Bilateral injection of Botox in the medial rectus muscle.|
|- Primary outcome||Proportion of successful motor alignment at six months. This will be measured with a synoptophore. Successful alignment is defined as ≤ ±10 prism diopters of residual esotropia at 6 months.|
|- Secondary outcome||1. Degree of esotropia (prism diopters);|
2. Time of onset esotropia;
3. Measurement of binocularity: alignment & fusion;
4. Percentages and duration of ptosis and exotropia (temporary side effects of botulinum injection);
5. Percentages of reinjection and additional alignment surgery;
6. BCVA at each visit and amblyopia;
7. Occurrence of vertical disturbances of ocular motility;
8. Adverse events.
|- Timepoints||Preoperatively, postoperatively at 2 and 10 weeks, at 6 months and at 1 and 2 years.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Rene Wubbels|
|- CONTACT for SCIENTIFIC QUERIES|| Rene Wubbels|
|- Sponsor/Initiator ||The Rotterdam Eye Hospital|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek Oogziekenhuis (SWOO)|
|- Brief summary||Rationale: |
In comparison to standard strabism surgery in patients with infantile esotropia, bilateral injection of Botox in the medial rectus muscle is conjectured to be equivalent with respect to motor alignment, while burden and risk are (because less invasive) expected to be less.
To determine the proportion of successful alignment after treatment of infantile esotropia with Botox.
Prospective case series.
Infantile esotropia < 6 years of age.
Bilateral injection of Botox in the medial rectus muscle.
Main study parameters/endpoints:
Proportion of successful motor alignment at six months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
As an alternative to conventional strabism surgery, treatment with Botox may be equally effective while both burden and risk are anticipated to be reduced.
|- Main changes (audit trail)|
|- RECORD||18-apr-2013 - 14-mei-2013|