Correction of Head Turn in Idiopathic Infantile Nystagmus

January 22, 2024 updated by: Sara Fawzy Ibrahim Mahmoud Eid, Zagazig University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of head turn
Time Frame: Base line and 6 months postoperatively.
assess the change from Baseline degree of head turn at 6 months postoperatively using protractor goniometer
Base line and 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual Acuity
Time Frame: Base line and 6 months postoperatively
assess the change from Baseline best corrected visual acuity at 6 months postoperatively
Base line and 6 months postoperatively
stereopsis
Time Frame: Base line and 6 months postoperatively.
assess the change from Baseline stereopsis at 6 months postoperatively using titmus fly test
Base line and 6 months postoperatively.
complications
Time Frame: 6 months postoperatively
report intraoperative and postoperative complications
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Head Turn in nystagmus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

names and affiliations of the participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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