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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However, at about the same time as the trial, transpupillary laser photocoagulation was introduced as a alternative treatment. A lack of standardized terminology and grading, and especially a lack of comparative clinical trial data, led to the reluctance of many clinicians to embrace this treatment. The method of treatment used in the study, peripheral retinal transscleral cryotherapy, was the form of retinal ablation most widely used at that time for treatment for ROP, and virtually all of the earlier clinical reports had used cryotherapy.
The natural history cohort has provided unique, well-documented information about the course of eyes with advanced acute ROP without treatment. This important finding led to the development of the ETROP and revised treatment recommendations for earlier treatment of patients with involvement of zone 1.
The outcome cry greatest interest, long-term visual function, cannot be measured until years after treatment.
Results of U.S. randomized clinical trial of cryotherapy for ROP (CRYO-ROP).
In addition, this trial led to innovations in the design and organization of randomized interventional trials that have gained wide acceptance and application in other fields.
Several complex factors may be responsible for the development of ROP. Stage IV — Partially detached retina. Formally, trials must be judged first on the ability to achieve the prospective goals of the investigation, generally a question of benefit and safety of the intervention being tested. Stage II — Moderately abnormal blood vessel growth.
Evaluation of the effects of cryotherapy will be based rpp examination findings in the posterior pole of the eye and on assessment of visual acuity, as in Phase II. However, some patients presented with asymmetric involvement, requiring a different randomization scheme, randomizing to treatment or no treatment in the single randomized eye. Ultimately, however, the most important measure of the impact of a clinical investigation is its influence on the clinical practice of crto.
The most important early visual function outcome reported was visual measurement using forced preferential looking tests of grating resolution Teller Acuity Card procedure. Grating visual acuity in eyes with retinal residua of retinopathy of prematurity: 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 reports of gop function.
Purchase access Subscribe to JN Learning for one year. 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 and randomization was stopped.
Results of U.S. randomized clinical trial of cryotherapy for ROP (CRYO-ROP).
The study found that this telemedicine approach to identifying severe ROP was about as accurate as regular examinations by an ophthalmologist. Few studies have so influenced the clinical care of ophthalmic disease and been so broadly accepted within the clinical community in such a short period. October 17, ; final revision received November 9, ; accepted November 18, Not all babies who are premature develop ROP.
Ablative treatment modalities have evolved as well, and currently laser retinal ablation is far more frequently used than cryotherapy, although the findings of the CRYO-ROP study are still the primary evidence used to support ablative treatment. Case series, mostly from Japan in the s and early s, supported the concept of peripheral retinal ablation for ROP during the acute phase, prior to the development of retinal detachment and retrolental fibroplasia.
The abnormal blood vessels grow toward the center of the eye instead of following their normal growth pattern along the surface of the retina. It is difficult to overestimate the impact of this well-designed trial in taking the concept of ablative treatment from controversial to near universal acceptance within a short period of time. 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.
Evaluating the Cryotherapy for Retinopathy of Prematurity Study (CRYO-ROP)
The most effective proven treatments for ROP are laser therapy or cryotherapy. Create a free personal account ceyo make a comment, download free article PDFs, sign up for alerts and more. A second examination by a different clinician was used as a measure to control for bias in staging. Create a free personal account to download free article PDFs, sign up for alerts, and more.
The disease improves and leaves no permanent damage in milder cases of ROP. The blood vessels grow gradually toward the edges of the developing retina, supplying oxygen and nutrients. However, in a small number of babies, ROP worsens, sometimes very rapidly. Post hoc analysis of enrollment suggests possible overrepresentation of black infants, multiple births, and boys.
Stage III — Severely abnormal blood vessel growth. Currently in the U. Sign in to save your search Sign in to your personal account.
The present study proposes to follow patients in the randomized group and a relatively small subgroup 67 of potentially high risk patients from the Natural History study through age 10 years, to determine whether the reduction in the benefit of cryotherapy seen between ages 12 and 42 months continues into mid-childhood.
These infants are at a much higher risk for ROP. Sign in to make a comment Sign in to your personal account. Follow-up to age 12 months indicated that cryotherapy reduced the incidence of unfavorable structural outcome by Long-term measurement roo refractive error suggests that both treated and untreated eyes with severe ROP have a high risk for high myopia.
The differences in treatment outcome among the eyes with different stages of ROP, especially zone 1 vs zone 2, cry also been an important finding in this study. If treatment for ROP does not work, a retinal detachment may develop. 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.
Create a free personal account to download free article PDFs, sign up for alerts, customize your interests, and more. Ccryo use of a separate data safety monitoring committee with authority cryyo prematurely halt the trial if treatment success could be determined with less than complete enrollment was a relatively new innovation at the time of this trial, although it has become routine now.
The paired analysis orp a strong control for environmental covariables in these complex cases with many factors that might influence visual outcomes. These data remain the best long-term information available about the consequences of ROP with and without treatment against which other Cryoo interventions are measured.