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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Stage II — Moderately abnormal blood vessel growth. Stage IV — Partially detached retina.

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

The use of a separate data safety monitoring committee with authority to 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.

Stage V — Completely detached retina and the end stage of the disease. 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.

Privacy Policy Terms of Use. These guidelines have evolved based on subsequent studies, but the basic CRYO-ROP epidemiological data remain the foundation fop the existing clinical guidelines for examination of premature infants.

These results were reported in the initial manuscripts published from the study.

Unfortunately, the roo also destroy some side vision. If, as the trial goals intended, 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.

Some of this caution was removed in the conclusions of the 3-month interval publication. 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. Because of this concern and others related to subject safety and ethical oversight, a special oversight committee was established within the study.

These technical and logistical limitations caused compromises in the design of the CRYO-ROP study related to recruitment and rrop, treatment, choice of outcomes to be measured, ethical factors, and statistical analysis. The existing information suggests that laser treatment is equivalent in effectiveness to cryotherapy.

Natural History Control Outcomes. As a result, new abnormal vessels begin to grow. Most other complications of ROP were also more frequent in control eyes, including corneal clouding, cataract, and glaucoma. Study conclusions and recommendations. Evaluation of the effects of cryotherapy will be based on examination findings in the posterior pole of the eye and on assessment of visual acuity, as in Phase II. The method of treatment vryo 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.

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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. It 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.

Often, only part of the retina detaches stage IV. Ctyo eye starts to develop at about 16 weeks of pregnancy, when the blood vessels top the retina begin to form at the optic nerve in the back of the eye. 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.

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.

Masked interpretation of fundus photographs taken at 3 and 12 months was chosen as the primary end point of the study.

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

Create a free personal account to make a comment, download free article PDFs, sign up for alerts and more. However, the magnitude of the benefit of treatment was exaggerated by this design when compared eop the vision outcomes. The influence of a clinical trial on the broader management of patients is the ultimate measure of the study’s impact. Follow-up to age 12 months indicated that cryotherapy reduced the incidence of unfavorable structural outcome by Patient Selection and Randomization.

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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 crryo be reached with fewer than the planned number of eyes randomized or if other significant safety or rpo concerns existed.

However, long-term follow-up has identified a low but persistent incidence of late retinal detachment in both treated and untreated eyes.

Cryo-Rop Visual Acuity Center – Michael Repka

The most important early visual function outcome reported was visual measurement using forced preferential looking tests of grating resolution Teller Acuity Card procedure. Measurement of visual function of children with associated developmental, neurological, and ophthalmic complications of their premature birth is very difficult and complex.

Randomizing one of symmetrically involved eyes also allows analysis based on discordant outcome between the two eyes, which would otherwise be cryk to have similar prognosis.

Grating visual acuity in eyes with retinal residua of retinopathy of prematurity: While ROP treatment decreases the chances for vision loss, it does not always prevent it. The quality of the information measured, including its statistical measurement and clinical relevance; the number and quality of publications produced from the data and their subsequent citation; the development of new tools for future clinical research and patient care; and secondary trials founded on the initial results are also important measures of the influence of a clinical investigation.

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.

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. Post hoc analysis of enrollment suggests possible overrepresentation of black infants, multiple births, and boys. Cryotherapy for active retinopathy of prematurity. By all these measures, CRYO-ROP has been highly successful, both in achieving its formal goals as well as rol information to support a new understanding of ROP and the development of visual impairment in young children.

Name Johns Hopkins University. Currently in the U. Nevertheless, there remain a substantial group rrop eyes,