Correction of Head Turn in Idiopathic Infantile Nystagmus

Sponsor
Zagazig University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05947331
Collaborator
(none)
28
1
2
20.9
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Graded Anderson procedure
  • Procedure: Kestenbaum procedure
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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)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 (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Graded Anderson Versus Kestenbaum Procedure for Correction of Head Turn in Idiopathic Infantile Nystagmus
Actual Study Start Date :
Apr 5, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I (Graded Anderson procedure)

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

Procedure: Graded Anderson procedure
In graded Anderson proceduren only recession of yoke muscles is done.

Active Comparator: Group II (Kestenbaum procedure)

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

Procedure: Kestenbaum 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.

Outcome Measures

Primary Outcome Measures

  1. Degree of head turn [Base line and 6 months postoperatively.]

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

Secondary Outcome Measures

  1. Best corrected visual Acuity [Base line and 6 months postoperatively]

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

  2. stereopsis [Base line and 6 months postoperatively.]

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

  3. complications [6 months postoperatively]

    report intraoperative and postoperative complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 30 Years
Sexes Eligible for Study:
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:
  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zagazig University Zagazig Egypt 44519

Sponsors and Collaborators

  • Zagazig University

Investigators

  • Study Director: Gamal Y EL-Mashad, Dr., professor of ophthalmology, Zagazig University
  • Study Chair: Emad M El-Hady, Dr., professor of ophthalmology, Zagazig University
  • Study Chair: Mostafa A Abdel-Aziz, Dr., Assisstant professor of ophthalmology, Zagazig University
  • Principal Investigator: sara F Ibrahim Mahmoud Eid, Master, Assisstant lecturer of Ophthalmology, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sara Fawzy Ibrahim Mahmoud Eid, Assisstant lecturer of ophthalmology, Zagazig University
ClinicalTrials.gov Identifier:
NCT05947331
Other Study ID Numbers:
  • Head Turn in nystagmus
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 17, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2023