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Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00279669
Enrollment
30
Registered
2006-01-19
Start date
2004-12-31
Completion date
2010-04-30
Last updated
2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity, Ultrasound, Eye

Brief summary

Premature infants stand a risk of danger to the layer of the eye that creates sight that, if untreated, can cause severe vision problems, leading to blindness in some cases. This research study will use ultrasound to examine the eye for retinal changes of prematurity.

Detailed description

Retinopathy of prematurity requires the early detection of retinopathy in neonates with a gestational age of \< 28 weeks and a birth weight \<1500 g. These evaluations require pupillary dilation, diagnostic expertise, consume much time and expense and are not without morbidity. B-scan ultrasonography using a hand-held probe is part of the current ophthalmologist's armamentarium, providing a non-invasive view of the eye and avoiding the morbidity associated with mydriatic drops used for pupillary dilation. We will use a simple water bath enclosure for a standard 20 MHz probe currently in general ophthalmic use to determine whether this simple technique might supplant indirect ophthalmoscopy as a screening technique. We will compare, using masked observers, the clinical findings of indirect ophthalmoscopy of neonatal infants with ultrasonic findings to determine if a correlation in the stages of retinopathy of prematurity (ROP) between the two techniques existed.

Interventions

PROCEDUREUltrasound examination

contact ultrasound examination

Sponsors

Columbia University
CollaboratorOTHER
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

premature birth

Exclusion criteria

* none

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026