Optic Discs in Children With Cerebral Palsy

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.

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Key information

Conditions

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

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Optic Disc Cupping

Time frame: Initial examination

Secondary outcomes

Optic disc size

Time frame: Inital examination

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

Optic Nerve Head Morphology in Children With Perinatal Onset Static Encephalopathy

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 9, 2008
Registry last updated: Apr 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed