Retinopathy of Prematurity Clinical Trials

Research on retinopathy of prematurity (ROP) that is supported by the National Eye Institute (NEI) of the National Institutes of Health involves four main clinical trials:

  • CRYO-ROP — Cryotherapy for Retinopathy of Prematurity-Outcome Study of Cryotherapy for Retinopathy of Prematurity Study. This trial was done to determine the safety and efficacy of Cryotherapy (freezing treatment) of the peripheral retina to reduce blindness in certain low-weight infants with ROP. The trial has ended but follow-up studies may be continuing. Original follow-up results confirmed that cryotherapy used on the eyes of premature infants helped save their sight.
  • Light-ROP — Effects of Light Reduction on Retinopathy of Prematurity. This study found that reduction of ambient (in the surrounding area) lighting did not reduce the incidence of ROP in low birth weight infants.
  • STOP-ROP — Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity. The results showed that a modest amount of oxygen given to infants with moderate cases of ROP did not help the condition, but did not worsen it either.
  • ETROP — Early Treatment for Retinopathy of Prematurity. This trial is being conducted to test whether earlier treatment in select cases of ROP will improve vision when compared to treatment at previous stages of the development of the disease. It does seem that earlier treatment is successful.

Retinopathy of Prematurity Information

Retinopathy of prematurity causes blindness in 400 and 600 infants who are born every year. It occurs in premature babies because the retina and eye go through a rapid developmental process in the last 12 weeks of pregnancy.

Those infants who are born prematurely and are no longer in the mother's womb lose the advantage of these last vital stages of development of the retina. The normal retinal development stops in infants who are born prematurely and abnormal changes begin to occur. The blood vessels, which have been continuing to develop across the surface of the retina, begin to grow towards the inside of the eye.

These abnormal blood vessels can lead to scarring, and as the scars heal and shrink, they pull the retina away from the wall of the eye. This is called a detached retina. If the retina becomes completely detached, the result is blindness.

ROP occurs in various stages of severity. In the first two stages, and sometimes in the third, the retina and blood vessels eventually develop normally. In the fourth stage, the retina has become partially detached and in the fifth stage, it is fully detached.

For more information, contact our ROP attorneys today.