Optic Discs in Children With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00769197
First received: October 8, 2008
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

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
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Optic Nerve Head Morphology in Children With Perinatal Onset Static Encephalopathy

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Optic Disc Cupping [ Time Frame: Initial examination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Optic disc size [ Time Frame: Inital examination ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769197

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

Publications:
Responsible Party: Deepta Ghate MD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00769197     History of Changes
Other Study ID Numbers: 2008-0082
Study First Received: October 8, 2008
Last Updated: April 28, 2009
Health Authority: United States: Institutional Review Board

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:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014