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Correction of Head Turn in Idiopathic Infantile Nystagmus

Z

Zagazig University

Status

Active, not recruiting

Conditions

Infantile Nystagmus Syndrome

Treatments

Procedure: Kestenbaum procedure
Procedure: Graded Anderson procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT05947331
Head Turn in nystagmus

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

5 to 30 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

28 participants in 2 patient groups

Group I (Graded Anderson procedure)
Active Comparator group
Description:
patients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure.
Treatment:
Procedure: Graded Anderson procedure
Group II (Kestenbaum procedure)
Active Comparator group
Description:
patients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure.
Treatment:
Procedure: Kestenbaum procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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