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Correction of Head Turn in Idiopathic Infantile Nystagmus

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05947331
Enrollment
28
Registered
2023-07-17
Start date
2022-04-05
Completion date
2025-04-30
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Nystagmus Syndrome

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.

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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

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)

Eligibility

Sex/Gender
ALL
Age
5 Years to 30 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Best corrected visual AcuityBase line and 6 months postoperativelyassess 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 postoperativelyreport intraoperative and postoperative complications

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026