Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
61 participants
OBSERVATIONAL
2008-06-30
2009-01-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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1
Children with birth/time of neurologic insult less than 28 weeks of gestation
No interventions assigned to this group
2
Children with birth/time of neurologic insult at more than 28 weeks of gestation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of static encephalopathy, cerebral palsy or CNS malformations
* Availability of CT head or MRI brain for review.
Exclusion Criteria
* 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
1 Day
17 Years
ALL
No
Sponsors
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University of Mississippi Medical Center
OTHER
Responsible Party
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University of Mississippi Medical Center
Principal Investigators
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Deepta Ghate, MD
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
Locations
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University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2008-0082
Identifier Type: -
Identifier Source: org_study_id