Optic Discs in Children With Cerebral Palsy

April 28, 2009 updated by: University of Mississippi Medical Center

Optic Nerve Head Morphology in Children With Perinatal Onset Static Encephalopathy

Hypothesis: Children born prematurely (between 8 and 9 months) with brain damage have an abnormal appearance of the optic nerve (nerve in eye) that resembles glaucoma (cupping) compared to those born before 8 months.

Purpose: to see how often children who are born prematurely and have suffered brain damage, have abnormal appearance of the optic nerve (nerve in the eye) which mimics glaucoma (cupping). This optic nerve cupping is most often seen when children are born after 8 months and is rarely seen in children born before 8 months.

Children born prematurely are known to have injuries to their brain as they are not yet fully developed. This often involves the part of the brain that involves vision. Clinicians have observed that these children have an abnormal appearance of the optic nerve (nerve in the eye), which has the appearance of glaucoma. These children often undergo extensive and often unnecessary invasive tests to rule out glaucoma. The investigators wish to establish the prevalence of this abnormality so that children are not subjected to unnecessary investigations. The investigators also want to understand how the optic nerve cupping (similar clinical picture as glaucoma) is related to the approximate timing and extent of the brain injury, the type of cerebral palsy and the motor disability of these children.

Study Overview

Status

Completed

Conditions

Detailed Description

This study will provide prevalence data on the occurrence of optic nerve head cupping in children with static encephalopathy in a much larger cohort than previously reported in literature (the largest cohort in literature is n=35). Children with a large optic nerve cup are treated as "glaucoma suspects". A routine glaucoma work-up in a child includes an examination under anesthesia or sedation, since children are unable to co-operate and stay still for accurate intraocular pressure measurements. These procedures often have to be periodically repeated and are a major financial burden. Importantly, they also carry substantial health risks, especially to the premature neonate who needs ICU monitoring after any anesthesia procedure. Roughly half of the children who undergo an examination under anesthesia for suspicion of glaucoma are found not to have the disease.

Children with a diagnosis of static encephalopathy attending the Pediatric Neurology clinic will be recruited. Interested patients will undergo a routine dilated eye examination after obtaining the consent and assent. The optic nerve head parameters (size, shape, color, cup-disc ratio, vessel tortuosity) will be recorded by 2 ophthalmologists experienced in the evaluation of the optic nerve. Some of the children (who are physically able to sit up in a chair and look straight ahead without blinking) will be offered disc photographs. This will be a one-time examination done during the routine clinic visit.

The prevalence of optic disc cupping (≥ 0.5) in a population of children with static encephalopathy with onset from 24-36 weeks will be obtained. Comparison of the cup/disc ratio in the 2 groups of children based on the approximate timing of the neurological insult will also be done.

The results of this study may allow pediatric ophthalmologists and glaucoma specialists to spare a child with static encephalopathy and isolated optic nerve head cupping extensive, risky and expensive glaucoma work-up.

This study will also provide more information on the patho-physiology of the developing visual nervous system.

Study Type

Observational

Enrollment (Actual)

61

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

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

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

1 day to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population will include all children attending the pediatric neurology clinic and carry a diagnosis of static encephalopathy or equivalent terms- CNS malformation syndrome or cerebral palsy.

Description

Inclusion Criteria:

  • Children born prematurely at age 24-36 weeks of gestation; are currently in the age group 0-17 years and enrolled in Dr Vedanarayanan's pediatric neurology clinic.
  • Diagnosis of static encephalopathy, cerebral palsy or CNS malformations
  • Availability of CT head or MRI brain for review.

Exclusion Criteria:

  • Parents/guardians or the child refuse consent or assent.
  • Presence of ocular media opacities preventing visualization of the fundus
  • The child is unable to cooperate for the ocular examination.
  • Coexistent diagnosis of glaucoma
  • Unable to obtain perinatal history from parents/guardians or records

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

Cohorts and Interventions

Group / Cohort
1
Children with birth/time of neurologic insult less than 28 weeks of gestation
2
Children with birth/time of neurologic insult at more than 28 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optic Disc Cupping
Time Frame: Initial examination
Initial examination

Secondary Outcome Measures

Outcome Measure
Time Frame
Optic disc size
Time Frame: Inital examination
Inital examination

Collaborators and Investigators

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

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Deepta Ghate, MD, University of Mississippi Medical Center

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

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

June 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (Estimate)

October 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 28, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0082

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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