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Correction of Head Turn in Idiopathic Infantile Nystagmus

Primary Purpose

Infantile Nystagmus Syndrome

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Graded Anderson procedure
Kestenbaum procedure
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Nystagmus Syndrome

Eligibility Criteria

5 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zagazig University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I (Graded Anderson procedure)

Group II (Kestenbaum procedure)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best corrected visual Acuity
assess the change from Baseline best corrected visual acuity at 6 months postoperatively
stereopsis
assess the change from Baseline stereopsis at 6 months postoperatively using titmus fly test
complications
report intraoperative and postoperative complications

Full Information

First Posted
July 5, 2023
Last Updated
July 12, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05947331
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Nystagmus Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (Graded Anderson procedure)
Arm Type
Active Comparator
Arm Description
patients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure.
Arm Title
Group II (Kestenbaum procedure)
Arm Type
Active Comparator
Arm Description
patients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure.
Intervention Type
Procedure
Intervention Name(s)
Graded Anderson procedure
Intervention Description
In graded Anderson proceduren only recession of yoke muscles is done.
Intervention Type
Procedure
Intervention Name(s)
Kestenbaum procedure
Intervention Description
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 Outcome Measure Information:
Title
Degree of head turn
Description
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 Outcome Measure Information:
Title
Best corrected visual Acuity
Description
assess the change from Baseline best corrected visual acuity at 6 months postoperatively
Time Frame
Base line and 6 months postoperatively
Title
stereopsis
Description
assess the change from Baseline stereopsis at 6 months postoperatively using titmus fly test
Time Frame
Base line and 6 months postoperatively.
Title
complications
Description
report intraoperative and postoperative complications
Time Frame
6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal Y EL-Mashad, Dr.
Organizational Affiliation
professor of ophthalmology, Zagazig University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emad M El-Hady, Dr.
Organizational Affiliation
professor of ophthalmology, Zagazig University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mostafa A Abdel-Aziz, Dr.
Organizational Affiliation
Assisstant professor of ophthalmology, Zagazig University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
sara F Ibrahim Mahmoud Eid, Master
Organizational Affiliation
Assisstant lecturer of Ophthalmology, Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University
City
Zagazig
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
names and affiliations of the participants
Citations:
PubMed Identifier
12234898
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.
Results Reference
result
PubMed Identifier
21061884
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.
Results Reference
result
Links:
URL
https://rdcu.be/df8N8
Description
Management of Congenital Nystagmus with and without Strabismus
URL
https://rdcu.be/df8Mh
Description
Graded Anderson procedure for correcting abnormal head posture in infantile nystagmus
URL
https://rdcu.be/df8MT
Description
High-dose Anderson operation for nystagmus-related anomalous head turn

Learn more about this trial

Correction of Head Turn in Idiopathic Infantile Nystagmus

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