Correction of Head Turn in Idiopathic Infantile Nystagmus

Infantile Nystagmus Syndrome Clinical Trial

Official title:

Graded Anderson Versus Kestenbaum Procedure for Correction of Head Turn in Idiopathic Infantile Nystagmus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05947331
• Other study ID #: Head Turn in nystagmus
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Infantile nystagmus is involuntary, bilateral, conjugate and rhythmic oscillations of the eyes which may present at birth or develop within the first 6 months of life. It may be idiopathic appearing without visual or neurological impairment or may be secondary to an afferent visual defect such as foveal hypoplasia, congenital cataract, retinal dystrophy or optic atrophy. Aiming at improving outcome of head turn in idiopathic infantile nystagmus, comparison between the efficacy and safety of graded Anderson procedure and Kestenbaum procedure is essential.

Description:

Infantile nystagmus related abnormal head position is noted according to the axis, it can be anomalous horizontally (right or left head turn), vertically (chin up or down), torsionally (right or left head tilt) or in a mixed pattern. A head turn to right or left is the most common compensatory posture encountered in patients with infantile nystagmus with an eccentric null position. A prolonged head turn (HT) may interfere with the social interactions and the quality of life and may lead to skeletal deformities in the cervical spine with postural dysfunction and impaired movement pattern. Thus, the correction of an abnormal head turn is important to enlarge the visual field, to eliminate the possibility of abnormal contracture of the neck muscles and to permit an adequate vision.Various extraocular muscle surgeries have been advised to correct infantile nystagmus-related HT. Despite being the most common surgical technique used till today for correction of head turn related to nystagmus, Kestenbaum procedure has variable long- term results, limited success rate and involves four rectus muscles (recession/ resection). In graded Anderson procedure, only yoke muscle recession is done based on the amount of initial head turn leaving two untouched muscles.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 30 Years

Eligibility

Inclusion Criteria:

Orthophoric Patients with idiopathic infantile nystagmus related head turn (=20 degrees - = 45 degrees) that is verified at least twice in two separate visits.

Exclusion Criteria:

1. Patients with infantile nystagmus secondary to ocular diseases

2. Patients with infantile nystagmus with associated strabismus.

3. Previous squint, scleral buckling or glaucoma surgeries.

4. Associated systemic or neurological disorders.

5. Patients with anisometropia = 5D.

6. Patients with nystagmus attenuated at near

Related Conditions & MeSH terms

• Infantile Nystagmus Syndrome

Intervention

Procedure:
• Graded Anderson procedure
In graded Anderson proceduren only recession of yoke muscles is done.
• Kestenbaum procedure
In Kestenbaum procedure, recession of yoke muscles and resection of their antagonists is done based on Parks table for Kestenbaum procedure according to the preoperative amount of head turn.

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Abadi RV, Bjerre A. Motor and sensory characteristics of infantile nystagmus. Br J Ophthalmol. 2002 Oct;86(10):1152-60. doi: 10.1136/bjo.86.10.1152. — View Citation

Hertle RW. Nystagmus in infancy and childhood: characteristics and evidence for treatment. Am Orthopt J. 2010;60:48-58. doi: 10.3368/aoj.60.1.48. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of head turn	assess the change from Baseline degree of head turn at 6 months postoperatively using protractor goniometer	Base line and 6 months postoperatively.
Secondary	Best corrected visual Acuity	assess the change from Baseline best corrected visual acuity at 6 months postoperatively	Base line and 6 months postoperatively
Secondary	stereopsis	assess the change from Baseline stereopsis at 6 months postoperatively using titmus fly test	Base line and 6 months postoperatively.
Secondary	complications	report intraoperative and postoperative complications	6 months postoperatively

External Links

•   Graded Anderson procedure for correcting abnormal head posture in infantile nystagmus
•   High-dose Anderson operation for nystagmus-related anomalous head turn
•   Management of Congenital Nystagmus with and without Strabismus