Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000156
Status:
COMPLETED
Last Update Posted:
2006-06-05
First Post:
1999-09-23
Brief Title:
The Effects of Light Reduction on Retinopathy of Prematurity Light-ROP
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the effect of ambient light reduction on the incidence of retinopathy of prematurity ROP
Detailed Description:
Despite progress during the past decade in treatment of ROP this disease still poses a significant approximately 21 percent risk of blindness to extremely low birth-weight 1251 grams preterm infants Current estimates indicate that about 27000 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 1251 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 andor 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 1251 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
For infants weighing less than 1251 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 andor 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 1251 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None