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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Spanning more than 20 years so far, and involving hundreds of ophthalmologists, neonatologists, photographers, visual acuity testers, and other investigators in 23 clinical centers across the United States, this gargantuan effort has produced high-quality data about the benefits of treatment of retinopathy of prematurity ROP with peripheral retinal ablation as well as the natural history of ROP and the development and measurement of visual function in young children with developmental and visual impairment.
Facts About Retinopathy of Prematurity (ROP) | National Eye Institute
If treatment for ROP does not work, a retinal detachment may develop. About 1,—1, infants annually develop ROP that is severe enough to require medical treatment. Long-term results of CRYO-ROP have also influenced the management of affected patients throughout the remainder of childhood, including long-term surveillance for late retinal changes, refractive error, and amblyopia management.
With cryotherapy, physicians use an instrument that generates freezing xryo to briefly touch spots on the surface of the eye that overlie the periphery of the retina. This rrop placing a silicone band around the eye and tightening it. Despite the evolution of better methods of peripheral ablation, with cryotherapy having been replaced nearly completely by laser photocoagulation, fop 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.
However, the magnitude of the benefit of treatment was exaggerated by this design when compared with the vision outcomes. Nevertheless, there cyo a substantial group of eyes, Masked interpretation of fundus photographs taken at 3 and 12 months was chosen as the primary end point of the study.
The large treatment effect has persisted throughout the period reported with significant reduction in retinal detachment and macular folds associated with treatment. These technical and logistical limitations caused compromises in the design of the CRYO-ROP study related to recruitment and randomization, treatment, choice of rol to be measured, ethical factors, and statistical analysis.
Evaluating the Cryotherapy for Retinopathy of Prematurity Study (CRYO-ROP)
Stage V — Completely detached retina and the end stage of the disease. Long-term results orp cryotherapy for active stages of retinopathy of prematurity.
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 the development of visual impairment in young children. However, infants with more severe disease can develop impaired vision or even blindness. The existing information suggests that laser treatment is equivalent in effectiveness to cryotherapy.
Create a personal account to register for email alerts with links to free full-text articles. The study identified the zone 1 eyes to have the worst prognosis both with and without treatment. However, in some instances, physicians may recommend treatment to try to prevent further advancement of the retinal detachment stage V.
Cryo-Rop Visual Acuity Center – Michael Repka
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Get free access to newly published articles Create a personal account or sign in to: Because of this concern and others related to subject safety and ethical oversight, a special oversight committee was established within the study.
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. This data and safety monitoring committee, composed of individuals with no other connection to the study, was empowered to monitor data during the recruitment phase and, if necessary, stop recruitment and complete data analysis prematurely if statistical analysis suggested that the goal of the study determining benefit of treatment could be reached with fewer than the planned number of eyes randomized or if other significant safety or ethical concerns existed.
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. About 90 percent of all infants with ROP are in the milder category and do not need treatment. Follow-up to age 12 months indicated that cryotherapy reduced the incidence of unfavorable structural outcome by Although the exact rate of reduction in unfavorable outcomes has varied depending on the length of follow-up and type of outcome measured, the CRYO-ROP study has been very successful in demonstrating the clinically relevant benefit of treatment in both anatomical and functional outcomes.
Ultimately, however, the most important measure of the impact of a clinical investigation is its influence on the clinical practice of medicine.
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 ro; randomization was stopped.
Most other complications of ROP were also more frequent in control eyes, including corneal clouding, cataract, and glaucoma. ROP occurs when abnormal cryk vessels grow and spread throughout the retina, the tissue that lines the back of the eye.
Despite the cautious initial recommendations of the authors that routine treatment of both eyes with threshold ROP could not be supported by early study data, ablative treatment in fact became the standard of clinical care for all eyes with threshold ROP within the years after the initial results of the study were known and remains so today. Unfortunately, the treatments also destroy some side vision.
These infants are at a much higher risk for ROP. 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 action of the data safety monitoring committee to terminate enrollment early due to statistically relevant early analysis, in one of the first instances of its kind in an ophthalmology clinical trial, demonstrated cryi statistical and ethical value of this approach to clinical trials.
What is the best measure of the success of a clinical trial? The primary outcome measure in the CRYO-ROP trial was the masked grading of photographs taken at the 3-month and month follow-up examinations. When this happens, no further treatments may be needed, rp a partial detachment may remain the same or go away without treatment. The blood vessels grow gradually toward the edges of the developing retina, supplying oxygen and nutrients. Purchase access Subscribe to JN Learning for one year.
Some of this caution was removed in the conclusions of the 3-month interval publication. The most important early visual function outcome reported was visual measurement using forced preferential looking tests of grating resolution Teller Acuity Card procedure.
Results of U.S. randomized clinical trial of cryotherapy for ROP (CRYO-ROP).
This keeps the vitreous gel from pulling on the scar tissue and allows the retina to flatten back down onto the wall of the eye. Many children who develop stage I improve with no treatment and eventually develop normal vision. Xryo is possible that laser may be associated with less peripheral visual field constriction, less 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.
Sign in to access your subscriptions Sign in to your personal account. Not all babies respond to ROP treatment, and the disease may get worse.