CompletedPhase 2ACTRN12612001257853

Red light (670nm) treatment to prevent retinopathy of prematurity (ROP)


Sponsor

Canberra Hospital

Enrollment

25 participants

Start Date

Feb 1, 2013

Study Type

Interventional

Conditions

Summary

Retinopathy of prematurity is a common complication of very premature delivery (less than 30 weeks gestation) and without appropriate screening and treatment can lead to retinal detachment and blindness. It is the leading cause of blindness in children. While in the uterus the fetus and the retina is developing in an environment where the partial pressure of oxygen is only 25-35 mmHg. Following premature delivery the retina is then exposed to partial pressures of oxygen of 60 mmHg and above. ROP has been shown to occur as a result of this hyperoxic exposure, and despite tight control on oxygen saturations which has led to a significant reduction in the disease, ROP still occurs in some part due to the fact that the retina is not meant to develop in this hyperoxic environment. Exacerbating this situation is that many of the neonates at most risk of ROP have significant lung disease of prematurity and as a consequence have recurrent episodes of hyper and hypoxia which occur despite attempts at tight control of oxygen delivery. 670nm red light is thought to act on the cytochrome c oxidative pathway (within cells of the body), which reduces the presence and production of oxygen free radicals. 670nm red light has been shown to reduce ROP in a mice and rat animal model. It has been used safely in the treatment of soft tissue injuries and mouth ulcers following radiation treatment and studies are ongoing with its use in diabetic retinopathy and age-related macular degeneration. This study aims to look at whether 670nm red light reduces the incidence of any stage of ROP and the incidence of ROP requiring laser surgery.


Eligibility

Sex: Both males and femalesMin Age: 24 WeekssMax Age: 30 Weekss

Inclusion Criteria2

  • Premature neonates less than 30 weeks gestation or less than 1150 grams birthweight
  • Informed consent obtained in the first 24-48 hours of life

Exclusion Criteria1

  • Significant chromosomal or congenital anomalies

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Premature neonates less than 30 weeks gestation or less than 1150 grams birthweight will be exposed to 670nm red light treatment daily for 15 minutes (9 Joules/cm2) from the first 24-48 hours of life

Premature neonates less than 30 weeks gestation or less than 1150 grams birthweight will be exposed to 670nm red light treatment daily for 15 minutes (9 Joules/cm2) from the first 24-48 hours of life until 34 weeks corrected age. The 670nm red light used will be the WARP 75 (Registered trademark light) (Food and Drug Administration (FDA) cleared for market medical devices (US Patent # 6,796,994 issued Sept. 2004)) which is placed on top of the neonates isolette 25cm above the baby in a similar fashion to that of phototherapy for hyperbilirubinaemia. Routine ophthalmological follow-up as inpatients will occur along with neurodevelopmental follow-up and ophthalomological follow-up at 2-3 years of age.


Locations(1)

ACT, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12612001257853


Related Trials