Infantile Nystagmus SyndromeNCT05947331
Correction of Head Turn in Idiopathic Infantile Nystagmus
A study testing Graded Anderson procedure and Kestenbaum procedure in people with Infantile Nystagmus Syndrome, run by Zagazig University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 30 years
- Conditions the study is for
- Infantile Nystagmus Syndrome
- What is being tested?
- Graded Anderson procedure and Kestenbaum procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2022to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Orthophoric Patients with idiopathic infantile nystagmus related head turn (≥20 degrees - ≤ 45 degrees) that is verified at least twice in two separate visits.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infantile Nystagmus Syndrome
- Being tested
- Graded Anderson procedure, Kestenbaum procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Anderson procedureProcedure or surgery
In graded Anderson proceduren only recession of yoke muscles is done.
Kestenbaum procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Graded Anderson procedure) | Active comparator | patients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure. Receives: Procedure: Graded Anderson procedure |
| Group II (Kestenbaum procedure) | Active comparator | patients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure. Receives: Procedure: Kestenbaum procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of head turn
assess the change from Baseline degree of head turn at 6 months postoperatively using protractor goniometer
Measured: Base line and 6 months postoperatively.
Secondary outcomes (3)
Best corrected visual Acuity
assess the change from Baseline best corrected visual acuity at 6 months postoperatively
Measured: Base line and 6 months postoperatively
stereopsis
assess the change from Baseline stereopsis at 6 months postoperatively using titmus fly test
Measured: Base line and 6 months postoperatively.
complications
report intraoperative and postoperative complications
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start5 Apr 2022
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infantile Nystagmus SyndromeStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sara Fawzy Ibrahim Mahmoud Eid, Zagazig University
- Investigators
- Gamal Y EL-Mashad, Dr., Study director, professor of ophthalmology, Zagazig UniversityEmad M El-Hady, Dr., Study chair, professor of ophthalmology, Zagazig UniversityMostafa A Abdel-Aziz, Dr., Study chair, Assisstant professor of ophthalmology, Zagazig Universitysara F Ibrahim Mahmoud Eid, Master, Principal investigator, Assisstant lecturer of Ophthalmology, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947331
- Sponsor's protocol ID
- Head Turn in nystagmus
- Status last verified
- Jan 2025
- First submitted
- 5 Jul 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: names and affiliations of the participants
Publications
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.
PubMed 12234898Hertle 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.
PubMed 21061884
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graded Anderson Versus Kestenbaum Procedure for Correction of Head Turn in Idiopathic Infantile Nystagmus
- ClinicalTrials.gov ID
- NCT05947331
- Acronym / sponsor ID
- Head Turn in nystagmus
- Conditions
- Infantile Nystagmus Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group I (Graded Anderson procedure) | Active comparator | Procedure: Graded Anderson procedurepatients with idiopathic infantile nystagmus related head turn corrected by graded Anderson procedure. |
| Group II (Kestenbaum procedure) | Active comparator | Procedure: Kestenbaum procedurepatients with idiopathic infantile nystagmus related head turn corrected by Kestenbaum procedure. |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Orthophoric Patients with idiopathic infantile nystagmus related head turn (≥20 degrees - ≤ 45 degrees) that is verified at least twice in two separate visits.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Anderson procedureIn graded Anderson proceduren only recession of yoke muscles is done. | Procedure or surgery | Group I (Graded Anderson procedure) |
| Kestenbaum procedureIn 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. | Procedure or surgery | Group II (Kestenbaum procedure) |
Primary outcome
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
3 secondary outcomes
Best corrected visual Acuity
Time frame: Base line and 6 months postoperatively
stereopsis
Time frame: Base line and 6 months postoperatively.
complications
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Results publication: PubMed 12234898Abadi 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 publication: PubMed 21061884Hertle 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.
- Management of Congenital Nystagmus with and without StrabismusLink provided by the sponsor.
- Graded Anderson procedure for correcting abnormal head posture in infantile nystagmusLink provided by the sponsor.
- High-dose Anderson operation for nystagmus-related anomalous head turnLink provided by the sponsor.
- Individual participant dataSharing planned: No. names and affiliations of the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal Y EL-Mashad, Dr. study director
professor of ophthalmology, Zagazig University
Emad M El-Hady, Dr. study chair
professor of ophthalmology, Zagazig University
Mostafa A Abdel-Aziz, Dr. study chair
Assisstant professor of ophthalmology, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Anderson procedure and Kestenbaum procedure in people with Infantile Nystagmus Syndrome, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of head turn (time frame: Base line and 6 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05947331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.