Optic Discs in Children With Cerebral Palsy

NCT00769197 | Completed

• 1 other identifier: 2008-0082
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

optic disc cupping; cerebral palsy; static encephalopathy; optic disc; optic nerve; periventricular Leukomalacia

Outcome Measures

Primary Outcomes (1)

• Optic Disc Cupping

  Initial examination

Secondary Outcomes (1)

• Optic disc size

  Inital examination

Study Arms (2)

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

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (4)

• Jacobson L, Hellstrom A, Flodmark O. Large cups in normal-sized optic discs: a variant of optic nerve hypoplasia in children with periventricular leukomalacia. Arch Ophthalmol. 1997 Oct;115(10):1263-9. doi: 10.1001/archopht.1997.01100160433007.

  PMID: 9338671 BACKGROUND

• Jacobson L, Hard AL, Svensson E, Flodmark O, Hellstrom A. Optic disc morphology may reveal timing of insult in children with periventricular leucomalacia and/or periventricular haemorrhage. Br J Ophthalmol. 2003 Nov;87(11):1345-9. doi: 10.1136/bjo.87.11.1345.

  PMID: 14609830 BACKGROUND

• McLoone E, O'Keefe M, Donoghue V, McLoone S, Horgan N, Lanigan B. RetCam image analysis of optic disc morphology in premature infants and its relation to ischaemic brain injury. Br J Ophthalmol. 2006 Apr;90(4):465-71. doi: 10.1136/bjo.2005.078519.

  PMID: 16547329 BACKGROUND

• Hellstrom A. Optic nerve morphology may reveal adverse events during prenatal and perinatal life--digital image analysis. Surv Ophthalmol. 1999 Oct;44 Suppl 1:S63-73. doi: 10.1016/s0039-6257(99)00067-3.

  PMID: 10548118 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Leukomalacia, Periventricular

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Deepta Ghate, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

US (1)