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Trial record 24 of 27 for:    "Periventricular Leukomalacia"

Optic Discs in Children With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769197
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : April 29, 2009
Information provided by:
University of Mississippi Medical Center

Brief Summary:

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.

Condition or disease
Cerebral Palsy

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.

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Optic Nerve Head Morphology in Children With Perinatal Onset Static Encephalopathy
Study Start Date : June 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Children with birth/time of neurologic insult less than 28 weeks of gestation
Children with birth/time of neurologic insult at more than 28 weeks of gestation

Primary Outcome Measures :
  1. Optic Disc Cupping [ Time Frame: Initial examination ]

Secondary Outcome Measures :
  1. Optic disc size [ Time Frame: Inital examination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00769197

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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
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Principal Investigator: Deepta Ghate, MD University of Mississippi Medical Center

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Responsible Party: Deepta Ghate MD, University of Mississippi Medical Center Identifier: NCT00769197     History of Changes
Other Study ID Numbers: 2008-0082
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by University of Mississippi Medical Center:
optic disc cupping
cerebral palsy
static encephalopathy
optic disc
optic nerve
periventricular Leukomalacia

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases