Correction of Head Turn in Idiopathic Infantile Nystagmus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infantile Nystagmus Syndrome

Intervention / Treatment
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* Procedure: Graded Anderson procedure
* Procedure: Kestenbaum procedure


Participation Criteria
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Eligibility Criteria
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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: Patients with infantile nystagmus secondary to ocular diseases Patients with infantile nystagmus with associated strabismus. Previous squint, scleral buckling or glaucoma surgeries. Associated systemic or neurological disorders. Patients with anisometropia ≥ 5D. Patients with nystagmus attenuated at near

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients with infantilenystagmus related head turn are divided randomly in two groups according to the surgical procedure to be performed Group I (Graded Anderson procedure);Group II (Kestenbaum procedure)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (Graded Anderson procedure)<br>patients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure. | Procedure: Graded Anderson procedure<br>* In graded Anderson proceduren only recession of yoke muscles is done.<br>|
| Active Comparator: Group II (Kestenbaum procedure)<br>patients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure. | Procedure: Kestenbaum procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual Acuity | assess the change from Baseline best corrected visual acuity at 6 months postoperatively | Base line and 6 months postoperatively | 
| stereopsis | assess the change from Baseline stereopsis at 6 months postoperatively using titmus fly test | Base line and 6 months postoperatively. | 
| complications | report intraoperative and postoperative complications | 6 months postoperatively |