Clinical trial NCT05947331: Correction of Head Turn in Idiopathic Infantile Nystagmus
Official title: Graded Anderson Versus Kestenbaum Procedure for Correction of Head Turn in Idiopathic Infantile Nystagmus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infantile Nystagmus Syndrome
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-07-17
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of head turn
timeFrame: Base line and 6 months postoperatively.
Secondary outcomes:
measure: Best corrected visual Acuity
timeFrame: Base line and 6 months postoperatively
measure: stereopsis
timeFrame: Base line and 6 months postoperatively.
measure: complications
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: professor of ophthalmology, Zagazig University
name: Gamal Y EL-Mashad, Dr.
role: STUDY_DIRECTOR
affiliation: professor of ophthalmology, Zagazig University
name: Emad M El-Hady, Dr.
role: STUDY_CHAIR
affiliation: Assisstant professor of ophthalmology, Zagazig University
name: Mostafa A Abdel-Aziz, Dr.
role: STUDY_CHAIR
affiliation: Assisstant lecturer of Ophthalmology, Zagazig University
name: sara F Ibrahim Mahmoud Eid, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.