Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00000156 |
| Other study ID # |
NEI-58 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
September 23, 1999 |
| Last updated |
June 2, 2006 |
| Start date |
July 1995 |
Study information
| Verified date |
October 2003 |
| Source |
National Eye Institute (NEI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial Summary
To evaluate the effect of ambient light reduction on the incidence of retinopathy of
prematurity (ROP).
Description:
Despite progress during the past decade in treatment of ROP, this disease still poses a
significant (approximately 2.1 percent) risk of blindness to extremely low birth-weight
(<1,251 grams) preterm infants. Current estimates indicate that about 27,000 infants of
extremely low birth weight are born annually, of which 74 percent will survive. As
techniques of managing smaller and less mature preterm infants continue to improve, it is
expected that the number of infants at risk for blindness will continue to increase.
For infants weighing less than 1,251 grams at birth, the Cryotherapy for Retinopathy of
Prematurity (CRYO-ROP) Study has shown that the risk of developing severe, acute (threshold)
ROP is 6 percent. Although cryotherapy, when applied at the time of threshold ROP, reduces
the rate of unfavorable visual outcome, 35 percent of eyes that develop this level of
severe, acute disease are blind 1 year after treatment. Moreover, cryotherapy is
destructive. Even when cryotherapy prevents progression to retinal detachment, it is
associated with peripheral retinal destruction and may, in some cases, be associated with
subnormal central vision due to high myopia and/or macular scarring. Corrective surgical
treatments for retinal detachment caused by ROP have proven to be of little visual benefit.
A preventive treatment for ROP that is safe, efficacious, easily applied, and inexpensive is
desirable.
The investigators hypothesize that reducing the amount of light that reaches the eyes of
preterm infants may be effective in preventing ROP. Although previous reports on the use of
light reduction to the eyes of preterm infants in the nursery have produced conflicting
results, there are sufficient reasons to believe that this strategy may be effective in
reducing the incidence and severity of ROP. These reasons center on the role of light in the
production of destructive free radicals. Supplemental oxygen produces the same free
radicals, and the two mechanisms may be additive.
In this masked, controlled study, infants weighing less than 1,251 grams at birth were
prospectively randomized within 24 hours of birth to wear goggles or not to wear goggles.
Goggles contain 97 percent near neutral density filters and were worn until the infant
reached either 31 weeks gestational age or 4 weeks postnatal age, whichever was longer. The
goggled and nongoggled infants were exposed to the same ambient light conditions within any
given Study Center. Eyes of all infants were examined on a prescribed schedule by certified
examiners to determine the incidence of any confirmed ROP.
The primary objective of this study is to answer the following question: Does light
reduction to the eyes of extremely low birth-weight infants decrease the incidence of any
confirmed ROP (at least 3 contiguous clock hours, any stage, any zone)? The primary end
points are therefore ROP or full vascularization.
The secondary objective of this study is to evaluate the following question: Does light
reduction to the eyes of extremely low birth-weight infants decrease the incidence of more
severe ROP (prethreshold ROP -- the secondary end point)?
The study has recruited approximately 400 infants, equally divided into goggle-wearing and
control group. Since randomization must occur within 24 hours of birth, the investigators
anticipate a mortality rate of between 10 percent and 20 percent of enrollees prior to
outcome. The study is in the followup phase with regular ophthalmologic exams until either
ROP regression or normal full retinal vascularization is established. A final exam occurs at
adjusted age 6 months.
