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Active, not recruitingNCT05947331Updated Jan 24, 2025

Correction of Head Turn in Idiopathic Infantile Nystagmus

An interventional study of Graded Anderson procedure and Kestenbaum procedure in Infantile Nystagmus Syndrome, sponsored by Zagazig University. Active, not recruiting at 1 site in Egypt. Open to participants aged 5 Years to 30 Years. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
5 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Infantile Nystagmus Syndrome

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03

Who can participate

Ages eligible
5 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
28 participants (actual)

Study arms

  • Active comparator
    Group I (Graded Anderson procedure)

    patients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure.

    Procedure: Graded Anderson procedure

  • Active comparator
    Group II (Kestenbaum procedure)

    patients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure.

    Procedure: Kestenbaum procedure

Interventions

  • ProcedureGraded Anderson procedure

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

  • ProcedureKestenbaum 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.

05

What researchers measure

Primary outcomes

  1. Degree of head turn

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

    Time frame: Base line and 6 months postoperatively.

Secondary outcomes

  1. Best corrected visual Acuity

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

    Time frame: Base line and 6 months postoperatively

  2. stereopsis

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

    Time frame: Base line and 6 months postoperatively.

  3. complications

    report intraoperative and postoperative complications

    Time frame: 6 months postoperatively

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Study locations

1 site
  • Zagazig University
    Zagazig, 44519, Egypt
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References and documents

Publications

  • 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. PubMed 12234898 ↗
  • 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. PubMed 21061884 ↗

Individual participant data

Plan to share: No — names and affiliations of the participants

08

Registry details

Key details

Study ID
NCT05947331
Lead sponsor
Zagazig University
Responsible party
Sara Fawzy Ibrahim Mahmoud Eid (Assisstant lecturer of ophthalmology, Zagazig University) — Principal investigator
First posted
Jul 17, 2023
Start date
Apr 5, 2022
Primary completion
Mar 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Jan 24, 2025

Study contacts

Gamal Y EL-Mashad, Dr.
study director · professor of ophthalmology, Zagazig University
Emad M El-Hady, Dr.
study chair · professor of ophthalmology, Zagazig University
Mostafa A Abdel-Aziz, Dr.
study chair · Assisstant professor of ophthalmology, Zagazig University
sara F Ibrahim Mahmoud Eid, Master
principal investigator · Assisstant lecturer of Ophthalmology, Zagazig University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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