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Correction of Head Turn in Idiopathic Infantile Nystagmus

Not Applicable
Active, not recruiting
Conditions
Infantile Nystagmus Syndrome
Interventions
Procedure: Graded Anderson procedure
Procedure: Kestenbaum procedure
Registration Number
NCT05947331
Lead Sponsor
Zagazig University
Brief 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.

Detailed 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 & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
28
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group I (Graded Anderson procedure)Graded Anderson procedurepatients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure.
Group II (Kestenbaum procedure)Kestenbaum procedurepatients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure.
Primary Outcome Measures
NameTimeMethod
Degree of head turnBase line and 6 months postoperatively.

assess the change from Baseline degree of head turn at 6 months postoperatively using protractor goniometer

Secondary Outcome Measures
NameTimeMethod
Best corrected visual AcuityBase line and 6 months postoperatively

assess the change from Baseline best corrected visual acuity at 6 months postoperatively

stereopsisBase line and 6 months postoperatively.

assess the change from Baseline stereopsis at 6 months postoperatively using titmus fly test

complications6 months postoperatively

report intraoperative and postoperative complications

Trial Locations

Locations (1)

Zagazig University

🇪🇬

Zagazig, Egypt

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