No registrations found.
ID
Source
Health condition
Infantile esotropia.
Sponsors and support
PO Box 70030
NL-3000 LM Rotterdam
tel: 010 4017777
Intervention
Outcome measures
Primary outcome
Proportion of successful motor alignment at six months. This will be measured with a synoptophore. Successful alignment is defined as ¡Ü ¡À10 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.
Background 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.
Objective:
To determine the proportion of successful alignment after treatment of infantile esotropia with Botox.
Study design:
Prospective case series.
Study population:
Infantile esotropia < 6 years of age.
Intervention:
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.
Study objective
The proportion of successful alignment after treatment of infantile esotropia with Botox is not inferior to conventional strabism surgery.
Study design
Preoperatively, postoperatively at 2 and 10 weeks, at 6 months and at 1 and 2 years.
Intervention
Bilateral injection of Botox in the medial rectus muscle.
Postbus 70030
Rene Wubbels
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4023449
ROI@oogziekenhuis.nl
Postbus 70030
Rene Wubbels
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4023449
ROI@oogziekenhuis.nl
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 ¡Ü 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3764 |
| NTR-old | NTR3959 |
| CCMO | NL42631.078.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39876 |