Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000133
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
1999-09-23
Brief Title:
Cryotherapy for Retinopathy of Prematurity CRYO-ROP - Outcome Study of Cryotherapy for Retinopathy of Prematurity
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 determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain low birth-weight infants with retinopathy of prematurity ROP for reducing blindness from ROP
To determine the long-term outcome for eyes that had severe threshold ROP both with and without cryotherapy
To determine the long-term outcome for eyes that had severe threshold ROP both with and without cryotherapy
Detailed Description:
ROP is a disease of the eyes of prematurely born infants in which the retinal blood vessels increase in number and branch excessively sometimes leading to hemorrhage or scarring Before the establishment of this study in 1985 more than 500 infants annually were blinded by ROP in the United States alone
More than 30 years ago the National Institutes of Health sponsored a clinical trial that showed that if premature babies are given oxygen only as needed the number of infants who develop ROP drops dramatically Subsequently hospitals cut back on giving excessive oxygen routinely to premature babies But with improvements in neonatal care over the last two decades the number of babies at risk is increasing as survival rates for smaller premature infants improve The lower the birth weight the higher the incidence and severity of ROP
In a more recent NEI-supported study at the University of Miami blood oxygen levels of very low birth-weight infants were monitored continuously by use of transcutaneous measurements as long as oxygen therapy was needed The study showed that there is no statistically significant difference between the rates of ROP in infants monitored on continuous oxygen therapy and in those monitored only when they were receiving oxygen in excess of 40 percent
The Supplemental Therapeutic Oxygen for Prethreshold ROP STOP-ROP trial also funded by the NEI studied whether a slight increase in oxygen therapy would prevent the progression of moderate ROP to ROP severe enough to require surgical treatment This intervention made little or no difference in outcomes
Likewise another NEI-sponsored clinical trial LIGHT-ROP demonstrated absence of protective effect on ROP by limiting light exposure to newborn premature infants These studies have led to the conclusion that factors other than oxygen or light exposure must be involved in causing ROP
In most infants who develop ROP the disease spontaneously subsides permitting development of normal vision But other infants who progress to a severe form of ROP are in danger of becoming permanently blind Although the cause of ROP is not fully explained scientists are seeking ways to treat ROP successfully and to find the right time in the progression of the disease to use treatment Cryotherapy which destroys the fringe of the retina through freezing is the only treatment so far that has been demonstrated to provide substantial benefit to these eyes
The multicenter trial of cryotherapy for ROP enrolled more than 4000 premature infants who weighed no more than 1250 grams at birth This category of infants is at the greatest risk of developing ROP The eyes of the infants enrolled in the study were examined at predetermined intervals while the subjects were still in the intensive care nursery After the pupils were dilated with eye drops the eyes were examined by an ophthalmologist using a binocular indirect ophthalmoscope to visualize the developing retina The natural history of the condition of each infants retina was recorded When examination disclosed the severe form of ROP threshold ROP in both eyes and the parents gave informed consent one of the infants eyes was randomly selected to receive cryotherapy In this technique a cryoprobe was used to freeze and thus destroy the peripheral extent of the retina thereby arresting the development of the blood vessels growing wildly toward it
Outcome of the therapy was assessed at 3 months and 12 months following randomization by an extensive examination that included photography of the interior of both the treated and the control eyes The 12-month exam also measured visual function with preferential-looking techniques Such measurements allowed correlations between fundus photographs and visual function and a comparison of visual function for treated versus control eyes Neither the trained photograph readers who evaluated the pictures from both eyes nor the specially trained vision testers knew which eyes had received cryotherapy Additional assessments of visual acuity and retinal status have been made approximately each year up to the present Currently 2001 preparations are being made for a 15-year outcome study that will conclude by 2003
More than 30 years ago the National Institutes of Health sponsored a clinical trial that showed that if premature babies are given oxygen only as needed the number of infants who develop ROP drops dramatically Subsequently hospitals cut back on giving excessive oxygen routinely to premature babies But with improvements in neonatal care over the last two decades the number of babies at risk is increasing as survival rates for smaller premature infants improve The lower the birth weight the higher the incidence and severity of ROP
In a more recent NEI-supported study at the University of Miami blood oxygen levels of very low birth-weight infants were monitored continuously by use of transcutaneous measurements as long as oxygen therapy was needed The study showed that there is no statistically significant difference between the rates of ROP in infants monitored on continuous oxygen therapy and in those monitored only when they were receiving oxygen in excess of 40 percent
The Supplemental Therapeutic Oxygen for Prethreshold ROP STOP-ROP trial also funded by the NEI studied whether a slight increase in oxygen therapy would prevent the progression of moderate ROP to ROP severe enough to require surgical treatment This intervention made little or no difference in outcomes
Likewise another NEI-sponsored clinical trial LIGHT-ROP demonstrated absence of protective effect on ROP by limiting light exposure to newborn premature infants These studies have led to the conclusion that factors other than oxygen or light exposure must be involved in causing ROP
In most infants who develop ROP the disease spontaneously subsides permitting development of normal vision But other infants who progress to a severe form of ROP are in danger of becoming permanently blind Although the cause of ROP is not fully explained scientists are seeking ways to treat ROP successfully and to find the right time in the progression of the disease to use treatment Cryotherapy which destroys the fringe of the retina through freezing is the only treatment so far that has been demonstrated to provide substantial benefit to these eyes
The multicenter trial of cryotherapy for ROP enrolled more than 4000 premature infants who weighed no more than 1250 grams at birth This category of infants is at the greatest risk of developing ROP The eyes of the infants enrolled in the study were examined at predetermined intervals while the subjects were still in the intensive care nursery After the pupils were dilated with eye drops the eyes were examined by an ophthalmologist using a binocular indirect ophthalmoscope to visualize the developing retina The natural history of the condition of each infants retina was recorded When examination disclosed the severe form of ROP threshold ROP in both eyes and the parents gave informed consent one of the infants eyes was randomly selected to receive cryotherapy In this technique a cryoprobe was used to freeze and thus destroy the peripheral extent of the retina thereby arresting the development of the blood vessels growing wildly toward it
Outcome of the therapy was assessed at 3 months and 12 months following randomization by an extensive examination that included photography of the interior of both the treated and the control eyes The 12-month exam also measured visual function with preferential-looking techniques Such measurements allowed correlations between fundus photographs and visual function and a comparison of visual function for treated versus control eyes Neither the trained photograph readers who evaluated the pictures from both eyes nor the specially trained vision testers knew which eyes had received cryotherapy Additional assessments of visual acuity and retinal status have been made approximately each year up to the present Currently 2001 preparations are being made for a 15-year outcome study that will conclude by 2003
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