Arch Ophthalmol. Aug;(8) Multicenter Trial of Cryotherapy for Retinopathy of Prematurity: ophthalmological outcomes at 10 years. Cryotherapy . The most effective proven treatments for ROP are laser therapy or cryotherapy. Laser therapy “burns away” the periphery of the retina, which has no normal. are discussed. Retinopathy of prematurity (ROP) is a leading cause of childhood blindness.’2 Cryotherapy was first used in the treatment of this condition in the.

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The very high rate of testability and the precision of the test results when compared with optotype recognition provided a major validation of the Teller Acuity Card procedure, 18 which has subsequently become widely used as a practical clinical tool and clinical research tool in pediatric ophthalmology. Natural History Control Outcomes. The paired analysis provides a strong control for environmental covariables in these complex cases with many factors that might influence visual outcomes.

Privacy Policy Terms of Use. What the primary outcomes did not demonstrate, but what has become clearer as the trial subjects have been followed up to an age when functional vision testing is possible, is that some patients with anatomically favorable outcomes still have poor vision.

Skip to main content. The purpose of the proposed study is to examine the long-term structural and functional effects of cryotherapy as a treatment for severe retinopathy of prematurity ROP.

Despite the evolution of better methods of peripheral ablation, with cryotherapy having been replaced nearly completely by laser photocoagulation, this study marks the point at which the treatment of ROP became data-driven and when the application of systematic screening and treatment for ROP became the standard of care in the clinical practice of neonatology.

Ideally, one would select perfectly matched cases to randomize for an interventional trial. These data remain the best long-term information available about the consequences of ROP with and without treatment against which other ROP interventions are measured.

The choice of an anatomic outcome was appropriately expedient, allowing earlier analysis, and the benefit of treatment has remained clinically and statistically relevant in subsequent vryo of visual function. Patients were recruited from admissions to the participating centers, potentially introducing a bias due to their tertiary nature and referral patterns.


At the year cro, Get free access to newly published articles Create a personal account or sign in to: Masked interpretation of fundus photographs taken at 3 and 12 months was chosen as the primary end point of the study.

The differences in treatment outcome among the eyes with different stages of ROP, especially zone 1 vs zone 2, have also been an important finding in this study. These new blood vessels are fragile and weak rpo can bleed, leading to retinal scarring. What is the best measure of the success of a clinical trial?

Results of U.S. randomized clinical trial of cryotherapy for ROP (CRYO-ROP).

Abstract Funding Institution Related projects Comments. Infants with ROP are considered to be at higher risk for developing certain eye problems later in life, such as retinal detachment, myopia nearsightednessstrabismus crossed eyesamblyopia lazy eyeand glaucoma. Long-term assessment of ocular fundus findings reported over the length of the study have also been very useful in understanding the lifelong anatomical issues related to ROP.

Long-term measurement of refractive error suggests that both treated and untreated eyes with severe ROP have a high risk for high myopia.

The study identified the zone 1 eyes to have the worst prognosis both with and without treatment. Create a free personal account to make a comment, download free article PDFs, sign up for alerts and more. Create a free personal account to access your subscriptions, sign up for alerts, and more. Cryotherapy for Retinopathy of Prematurity Cooperative Group. CRYO-ROP changed tremendously the way we treat ROP from the previously highly variable strategies, including everything from nonintervention to treatment of even mild cases, to the current nearly universal application of peripheral retinal ablation at specific levels of severity based on evidence from this and subsequent randomized trials.

The epidemiological description of patients reaching threshold ROP in the study prior to randomization was an important collection of data and has been used to develop screening recommendations. With cryotherapy, physicians use an instrument that generates freezing temperatures to briefly touch spots on the surface of the eye that overlie the periphery of the retina. Follow-up to age 12 months indicated that cryotherapy reduced the incidence of unfavorable structural outcome by The quality of the data obtained, the study design, and the decision to terminate enrollment early when the benefit of treatment was apparent set standards against which current and future clinical treatment trials will be measured.


Currently in the U. Not all babies who are premature develop ROP. Transscleral laser photocoagulation has also been reported. Sign in to download free article PDFs Sign in to access your subscriptions Sign in to your personal account.

Influence of the study on subsequent clinical investigations. However, infants with more severe disease can develop impaired vision or even blindness.

Facts About Retinopathy of Prematurity (ROP) | National Eye Institute

Stage III — Severely abnormal blood vessel growth. It led to the publication of 50 or more manuscripts directly and has influenced many more publications and studies indirectly. ROP occurs when abnormal blood vessels grow and spread throughout the retina, the tissue that lines the back of the eye. These guidelines have evolved based on subsequent studies, but the basic CRYO-ROP epidemiological data remain the foundation of the existing clinical guidelines for examination of premature infants.

At the time of the development of the CRYO-ROP study in the mid s, accumulating anecdotal experience and small case series suggested the procedure was safe and showed possible benefit, 56 but at the time of the initiation of this trial, there was no widely endorsed treatment strategy and therefore no universal screening criteria. The smaller a baby is at birth, the more likely that baby is to develop ROP. Many other secondary outcomes have been reported in the publications of study data.

The study determined that light reduction has no effect on the development of a potentially blinding eye disorder in low birth weight infants. Purchase access Subscribe to the journal.

Evaluating the Cryotherapy for Retinopathy of Prematurity Study (CRYO-ROP)

When, as anticipated by this study design, it became apparent that the benefit of treatment was significantly greater than initially estimated, the data safety monitoring committee exercised its prerogative, and subject recruitment cdyo randomization was stopped. Today, with advances in neonatal care, smaller and more premature infants are being saved.

Post hoc analysis of enrollment suggests possible overrepresentation of black infants, multiple births, and boys.

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