A pilot randomised clinical trial of 670nm red light for reducing retinopathy of prematurity

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000371190

Acronym

RED ROP RCT

Enrollment

Registered

2019-03-11

Start date

2015-03-01

Completion date

2017-01-30

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Retinopathy of Prematurity (ROP) is a vaso-proliferative disorder of the retina affecting extremely preterm or low birth weight infants. The most devastating consequence of ROP is retinal detachment and blindness, which in most developed countries is reduced by careful screening and early treatment with either laser ablation of vessels or intravitreal injection of anti-vascular endothelial growth factor (VEGF). However, ROP remains the leading cause of visual loss in children. Photobiomodulation using 670 nm red light might provide a novel treatment strategy to reduce the hyperoxic stage of ROP, by reducing the harmful effects of ROS and restoring normal vessel development. Photobiomodulation using 670nm red LED light in oxygen induced retinopathy animal models (which mimics facets of ROP including neonvascularisation and photoreceptor cell death) reduced the extent of oxygen induced retinal neovascularisation, decreased pulmonary haemorrhage and improved survival.The aims of this pilot randomised controlled trial were to: 1) determine feasibility of randomisation within 24-48 hours after birth; and 2) determine if treatment with 670nm red LED light at a distance of 25cm providing 9 J/cm2 in very premature neonates provided similar results to previously published animal studies in reducing ROP and improving survival.

Interventions

Preterm neonates will be randomized to receive either 15 minutes of 670 nm red light or no treatment daily from 24-48 hours after birth until 34 weeks corrected gestation. The treatment allocation will be delivered by nursing staff and adherence checked on bedside research proforma.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 48 Hours

Healthy volunteers

Inclusion criteria

Less than 30 weeks gestation or less than 1150 grams at birth Randomised within 48 hours after birth

Exclusion criteria

Chromosomal or significant congenital anomalies

Outcome results