Trials / Completed
CompletedNCT00279669
Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Ultrasound examination | contact ultrasound examination |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2010-04-30
- Completion
- 2010-04-30
- First posted
- 2006-01-19
- Last updated
- 2019-03-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00279669. Inclusion in this directory is not an endorsement.