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NCT Number: NCT05947331

Correction of Head Turn in Idiopathic Infantile Nystagmus

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

5 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Graded Anderson procedure

Procedure

In graded Anderson proceduren only recession of yoke muscles is done.

Kestenbaum procedure

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.

Primary outcomes

  1. Degree of head turn

    Time frame: Base line and 6 months postoperatively.

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

Secondary outcomes

  1. Best corrected visual Acuity

    Time frame: Base line and 6 months postoperatively

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

  2. stereopsis

    Time frame: Base line and 6 months postoperatively.

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

  3. complications

    Time frame: 6 months postoperatively

    report intraoperative and postoperative complications

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2023
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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