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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In the study, non-physician staff in the NICU were trained to take the photos, which were made available to trained image readers, who evaluated whether the babies needed to be referred for potential treatment. 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.
It is possible that laser may be associated with less cruo visual field constriction, fryo pathological myopia, and lower risk of macular retinopathy, 1314 but it is unlikely that a large-scale comparative trial would be feasible because of the almost universal adoption of laser photocoagulation. Some of this caution was removed in the conclusions of the 3-month interval publication.
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Cryo-Rop Visual Acuity Center – Michael Repka
A second examination by a different clinician was used as a measure to control for bias in staging. The study determined that light reduction has no effect on the development of a potentially blinding eye disorder in low birth weight infants.
When a baby is born full-term, the retinal blood vessel growth is mostly complete The retina usually finishes growing a few weeks to a month after birth.
Cryotherapy for Retinopathy of Prematurity Cooperative Group. Thus, even before the publication of the initial manuscript, many clinicians had adopted screening and treatment guidelines similar to those used in the study in anticipation of favorable results.
Stage II — Moderately abnormal blood vessel growth. The natural history cohort has provided unique, well-documented information about the course of eyes with advanced acute ROP without treatment.
The study design required staging by strict clinical criteria, but the nature of the disease and its rapid pace did not allow masked, photographic interpretation prior to randomization as has been done in other large randomized trials of retinal disease such as the Diabetic Retinopathy Treatment Study. The existing information suggests that laser treatment is equivalent in effectiveness to cryotherapy.
The cruo 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. Long-term results of cryotherapy for active stages of retinopathy of prematurity. It is possible that treatment at an earlier stage may also have been effective in some cases, and this is the subject of a subsequent, second-generation study of laser panretinal photocoagulation for ROP, the Early Treatment for Retinopathy of Prematurity trial ETROP.
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. Currently in the U. Skip to main content. Copyright American Medical Association.
However, this was the first major multicenter clinical trial to use a standardized procedure, including masked examiners and standardized presentation of gratings.
Name Johns Hopkins University. The study found that this telemedicine approach to identifying severe ROP was about as accurate as regular examinations by an ophthalmologist. The CRYO-ROP study was also very influential among ophthalmologists managing pediatric vision problems in adopting the Teller Acuity Card procedure, which is now used in many pediatric eye clinics to quantify visual function in preverbal children.
However, some patients presented with asymmetric involvement, requiring a different randomization scheme, randomizing to treatment or no treatment in the single randomized eye.
Results of U.S. randomized clinical trial of cryotherapy for ROP (CRYO-ROP).
These infants are at a much higher risk for ROP. Nevertheless, there remain a substantial group of eyes, By judicious choice of a threshold for treatment that allowed a statistically and clinically relevant improvement in outcomes, and by choosing outcome measures that were both expeditious fundus appearance and relevant visual functionthe study planners created a framework for answering the important question of treatment crjo from ablative therapy.
Some infants who develop stage III improve with no treatment and eventually develop normal vision. 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. Get free access to newly published articles Create a personal account or sign in to: Other measurements of visual function also showed significant benefit in treated eyes, including contrast sensitivity and visual fields.
Long-term measurement of refractive error suggests that both treated and untreated eyes with severe ROP have a high risk for high myopia. The lack of reproducible, objective assessments of pretreatment staging is a limitation of the study design and may have introduced bias and variability in the data despite the efforts in the study to train and standardize classification among the investigators and centers.
Patient Selection and Randomization. Because of this concern and others related to subject safety and ethical oversight, a special oversight committee was established within the study.
However, in some instances, physicians may recommend treatment to try to prevent further advancement of the retinal detachment stage V. The difficulty in precisely measuring visual acuity and the effect of nonocular visual pathway abnormalities in these children limit the interpretation of vision as a secondary outcome.
The large treatment effect has persisted throughout the period reported with significant reduction in retinal detachment and macular folds associated with treatment. The early results of the trial also showed what had become apparent clinically to the ophthalmologists with dop with cryotherapy: Both laser treatment and cryotherapy destroy the peripheral areas of the retina, slowing or reversing the abnormal growth of ro vessels.
The differences in treatment outcome among the eyes eop different stages of ROP, especially zone 1 vs zone 2, have also been an important finding in this study.
This keeps the vitreous gel from pulling on the scar tissue and allows crjo retina to flatten back down onto the wall of the eye.
The Teller Acuity Card procedure and similar forced preferential looking grating tests, while not perfect proxies for optotype visual acuity, have contributed to the clinical treatment of amblyopia, cataracts, and other vision problems in children in addition to ROP.
Cryotherapy for active retinopathy of prematurity. Many children who develop stage I improve with no treatment and eventually develop normal vision. If, as the trial goals ctyo, a benefit was seen with cryotherapy, randomized patients were eligible to have this benefit only in one eye and were not eligible to be treated in the opposite control eye.
Purchase access Subscribe to JN Learning for one year. However, at about the same time as the trial, transpupillary laser ro; was introduced as a alternative treatment. October 17, ; final revision received November 9, ; accepted November 18, Ethical concerns also complicated the development of this study design.
Many children who develop stage II improve with no treatment and eventually develop normal vision. By all these measures, CRYO-ROP has been highly successful, both in achieving its formal goals as well as developing information to support a new understanding of ROP and ro; development of visual impairment in young children.