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Biomedical subjects

D B Schaffer

Publications and source records attributed to D B Schaffer.

At least 19 recordsLinked to original sources

Outcome-based management of retinopathy of prematurity. Multicenter Trial of Cryotherapy for Retinopathy of prematurity Cooperative Group.

PURPOSE: A system is presented for sequentially computing the risk of progression of retinopathy of prematurity (ROP) for infants born weighing not more than 1250 gm. A personal computer program is used to monitor infants' risk of threshold ROP from first appearance of ROP, and the progression in severity is tracked with multiple logistic risk models developed from data in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. METHODS: After entry of the infant's birth weight, gestational age, ethnicity, birth in the current hospital or elsewhere, single or multiple birth, and maturity zone of retinal vessels, risk of progression to threshold severity is calculated. New estimates of risk are computed at onset of ROP and prethreshold ROP (any zone I ROP, zone II stage 2+ or 3) according to the extent of retinal vascularization when ROP first appears, how rapidly ROP progresses, and how severe it is. When threshold ROP (8 total or 5 contiguous clock hours of stage 3+ in zone I or II) is reached,the system provides separate estimates of risk that the eye will have an unfavorable 3-month outcome if treated or not. RESULTS: Estimates of risk of progression to threshold disease among the 4099 patients in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity natural history study varied from less than 1% to more than 70%. For eyes with threshold disease, the risk of an unfavorable outcome at 3 months without treatment varied from less than 10% to more than 90%. CONCLUSION: This method of tracking identifies infants at high risk for severe ROP and poor structural outcome. It provides information about prognosis with a specificity heretofore impossible.

Algorithms↗

Extracorporeal membrane oxygenation causing asymmetric vasculopathy in neonatal infants.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary bypass therapy used in term or near-term infants with severe cardiorespiratory disorders not responsive to conventional intensive care interventions. An ECMO-associated retinal vasculopathy has been described with little reference to the specific condition of the patient. We examined the eyes of 91 infants who underwent ECMO treatment. An assessment was made of the following: (1) when retinal changes occurred, (2) whether there was a particular systemic disorder or ECMO approach associated with these retinal findings, and (3) whether there may be ocular sequelae from this development. METHODS: Ninety-one neonates were treated with ECMO for meconium aspiration syndrome (MAS), primary persistent pulmonary hypertension of the newborn, sepsis, congenital diaphragmatic hernia (CDH), respiratory distress syndrome (RDS), and blood aspiration. Venoarterial bypass was performed in 73 patients. The remaining 18 patients underwent venovenous bypass. Ophthalmologic examinations were performed during bypass in 6 infants and within 3 weeks of ECMO in the remainder. RESULTS: Asymmetric retinopathy (left eye > right eye) was discovered in six infants with CDH and in one infant with RDS within a 2-week period after bypass, demonstrating venous tortuosity with or without intraretinal hemorrhages. One infant treated for MAS had a left eye intraretinal hemorrhage only. All patients with the noted retinal changes underwent venoarterial cannulation. Six of 9 patients with CDH had retinal findings noted compared with 1 of 10 patients with RDS and 1 of 35 patients with MAS. CONCLUSION: Because we were able to examine infants while they were receiving ECMO or shortly after termination of bypass, asymmetric vasculopathy was found in a greater percentage of our patients compared with a similar large case series. ECMO-associated retinal vasculopathy appeared to disproportionately occur in those patients with CDH who underwent venoarterial bypass. Further study of retinal vascular changes in patients with CDH should be performed to assess long-term effects.

Extracorporeal Membrane Oxygenation↗

Comitant esodeviation resulting from neurologic insult in children.

PURPOSE: Our purpose was to establish whether comitance was a common or uncommon finding in children with esodeviation associated with a neurologic insult. METHODS: A retrospective chart review was performed of children with acquired esodeviation associated with an identifiable neurologic insult. RESULTS: Examinations of 30 children seen over a 2-year period were analyzed. Twenty-two (73%) had brain tumors. Twelve (40%) had comitant esodeviation, and the other 18 (60%) had incomitant measurements. Of the patients with comitant esodeviation, 6 had normal abduction OU (two after recovery from bilateral sixth nerve palsies), and 6 had mild or minimal abduction deficits. Moderate or severe abduction deficits were associated with incomitant measurements. CONCLUSIONS: Comitant esodeviation can be common in children with identifiable neurologic insults.

Accommodation, Ocular↗

Measurement of Goldmann visual fields in older children who received cryotherapy as infants for threshold retinopathy of prematurity.

BACKGROUND: Cryotherapy administered to eyes with severe acute-phase (threshold) retinopathy of prematurity benefits retinal structure and visual acuity compared with the natural course of the retinopathy. OBJECTIVES: To determine the extent of peripheral field abnormalities in eyes with threshold retinopathy of prematurity that had retinal structure preserved by cryotherapy. METHODS: Kinetic perimetry was performed with a Goldmann perimeter by masked testers on patients in whom bilateral threshold retinopathy of prematurity developed and who had been randomly assigned to undergo cryotherapy in one eye and no cryotherapy in the fellow eye. With the V-4-e and the II-4-e targets, eight meridians were tested: 0 degrees, 45 degrees, 90 degrees, 135 degrees, 180 degrees, 225 degrees, 270 degrees, and 315 degrees. The median value of three presentations in each meridian was accepted as the extent in that meridian. RESULTS: Fourteen eyes (eight treated and six control) of eight patients (mean age, 9.9 years; range, 6 to 11 years) had adequate vision to undergo fields testing. Mean (+/-SE) extent of visual field for treated vs control eyes was 36 degrees +/- 3 degrees vs 46 degrees +/- 6 degrees for the II-4-e target and 49 degrees +/- 4 degrees vs 59 degrees +/- 6 degrees for the V-4-e target. This difference was consistent across all eight meridians for either target, and repeated-measures analysis of variance showed that cryotherapy was associated with smaller visual field extent for both target sizes (P=.08). CONCLUSION: The results of this small pilot study suggest that eyes that have retinal structure and acuity preserved by cryotherapy for severe acute-phase retinopathy of prematurity have slightly smaller visual fields than untreated eyes with severe acute-phase retinopathy of prematurity that had vision preserved.

Acute Disease↗

Prognostic factors in the natural course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group.

BACKGROUND: There exists no reliable information that allows the ophthalmologist to predict with any degree of certainty a particular infant's chances of requiring surgical treatment for retinopathy of prematurity (ROP) or of reaching an unfavorable outcome on the basis of the retinal findings at the time of the nursery examination. METHODS: In the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP), 4099 infants weighing less than 1251 g at birth underwent eye examinations that began at 4 to 6 weeks after birth and subsequently continued at 2-week intervals. Independent variables in the population were studied using multiple logistic regressions. RESULTS: An increased risk of reaching threshold ROP was found associated with lower birth weights, younger gestational age, white race, multiple birth, and being born outside a study center nursery. For infants who developed ROP (66%), corresponding probabilities are presented for developing severe ("threshold") ROP or of having an unfavorable macular outcome. The risk of an unfavorable macular outcome was increased with zone 1 ROP, "plus" disease, the severity of the stage, and the amount of circumferential involvement. A higher risk also was associated with a rapid rate of progression of ROP to prethreshold disease but not with the postconceptional age at which ROP was first noted. CONCLUSION: The findings indicate that the ocular characteristics of ROP, along with some easily identifiable and available basic systemic and demographic information about an infant, can assist the ophthalmologist in understanding variations in an individual baby's chance for a good or poor macular outcome.

Child, Preschool↗

Operational aspects of terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group.

The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) is a randomized clinical trial sponsored by the National Eye Institute (NEI) designed to test whether cryotherapy applied to eyes of premature infants with a specified extent of stage 3+ ROP significantly decreases the incidence of an unfavorable outcome. An unfavorable outcome is defined as either retinal detachment or a retinal fold and was determined at 3 months posttreatment by the use of a masked photographic system. Enrollment into the trial was terminated on recommendation of the Data and Safety Monitoring Committee 9 months before the scheduled closing date for enrollment because of demonstrated treatment benefit. The purpose of this article is to discuss the operations involved in the orderly termination of enrollment and dissemination of results from this trial. These activities included preparation of trial participants and staff, release of trial information, continuing patient care, data collection and coding, and publication of trial results.

Blindness↗

Incidence and early course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group.

In the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (ROP), 4099 infants weighing less than 1251 g at birth underwent sequential ophthalmic examinations, beginning at age 4 to 6 weeks, to monitor the incidence and course of ROP. Overall, 65.8% of the infants developed ROP to some degree; 81.6% for infants of less than 1000 g birth weight. As expected, ROP incidence and severity were higher in lower birth weight and gestational age categories. Black infants appeared less susceptible to ROP, of all severity categories, than nonblack infants. The timing of retinal vascular events correlated more closely with postconceptional age than with postnatal age, implicating the level of maturity more than postnatal environmental influences in governing the timing of these vascular events. These results include the current incidence of various severity stages of ROP found in the United States and provide new insight into the development of ROP.

Cryosurgery↗

Systemic complications associated with retinal cryoablation for retinopathy of prematurity.

Eighty infants with proliferative retinopathy of prematurity (ROP) were treated with peripheral retinal cryoablation. Among the serious systemic complications encountered were three instances of respiratory arrest and one of cardiorespiratory arrest. Recommendations that may help prevent these adverse systemic effects in premature infants include: (1) avoidance of excess subconjunctival anesthetic doses, (2) preoperative administration of systemic atropine to minimize the oculocardiac reflex, (3) consideration of an analgesic agent to decrease the pain and exhaustion, and (4) cardiorespiratory monitoring in a hospital setting, with an intravenous line in place, at the time of treatment.

Anesthetics↗

Chorioretinal folds and a macular hole secondary to craniofacial surgery.

Chorioretinal folds have been reported as a result of many intraocular and extraocular inflammatory processes or tumors. Visual loss is usually secondary to a combination of the underlying process and chorioretinal folds involving the macula. We report a patient who developed decreased vision, metamorphopsia, chorioretinal folds, and a lamellar macular hole secondary to global compression by a bone fragment. The chorioretinal folds regressed and his vision stabilized following surgical decompression. Chorioretinal folds and lamellar macular hold formation are previously unrecognized complications of reconstructive craniofacial surgery.

Adult↗

Oculocutaneous albinism associated with congenital glaucoma.

An infant with oculocutaneous albinism and congenital glaucoma is described. The association of these two uncommon congenital disorders might suggest a common defective factor. Theoretically this patient broadens the spectrum of disorders of neural crest cell migration associated with albinism.

Albinism↗

Cryotherapy for active retinopathy of prematurity.

Twenty-eight patients with bilateral symmetrical stage-III retinopathy of prematurity and plus disease had one eye treated using cryotherapy, while the other acted as a control. Eleven patients showed improvement in both the treated and untreated eye, while 11 others were noted to improve in the treated eye while demonstrating deterioration in the untreated eye. The P value obtained by applying binomial distribution tests suggested that, in the sampled population, cryotherapy was preferable to no treatment.

Clinical Trials as Topic↗

Cryotherapy for active retinopathy of prematurity.

Twenty-eight patients with bilateral symmetrical Stage 3 retinopathy of prematurity (ROP) and plus disease had one eye assigned to cryotherapy and the other to control. The majority of patients weighed under 1000 grams at birth and females outnumbered males by nearly a two-to-one ratio.+ Cryotherapy was generally performed at a gestational age of less than 40 weeks and a mean chronologic age of 10 weeks. Eleven patients showed improvement in both the treated and untreated eyes possibly due to variables among prematures not identified in the study. Eleven other patients experienced improvement in the treated eye and progression in the untreated eye. Using the binomial distribution on the latter group the P value was 0.0005 with a one-tailed hypothesis test and 0.001 with a two-tailed test, suggesting that in the sampled population cryotherapy appears to be preferred over no treatment.

Cryosurgery↗

Vitamin E and retinopathy of prematurity. Follow-up at one year.

Five hundred forty-five infants weighing less than 1501 g at birth were entered into a randomized, prospective study to determine the effect of high serum levels (5 mg/dL) of vitamin E used prophylactically to try to prevent or alter the natural course of retinopathy of prematurity (ROP) and its sequel, retrolental fibroplasia (RLF). Three hundred twenty-eight infants were available for the one- to two-year eye examination. Although there was a trend (P = 0.072) toward less severe RLF among vitamin E-treated infants, the incidence of RLF was 11/162 (6.8%) in the placebo treated (P) infants, and 12/166 (7.2%) in the vitamin E-treated (E) infants. The incidences of hyperopia, myopia, anisometropia, strabismus and amblyopia were also similar in both the P and E groups.

Cicatrix↗

Sequelae of arrested mild retinopathy of prematurity.

Twenty-six infants with totally resolved low-grade retinopathy of prematurity (ROP) were compared with a similar group of 38 premature infants in whom no retinopathy had ever developed in the nursery. At the examination performed at a physiologic age of 1 year, the two groups were almost indistinguishable with respect to their refractive errors, strabismus, and amblyopia. The incidence and severity of mild to moderate anisometropia was increased in the resolved ROP group. It appears that there is a group of infants in whom absolute resolution occurs, with few residua of active ROP. This is especially true when there are no anatomical retinal findings consistent with low-grade cicatricial retrolental fibroplasia at 1 year of age.

Amblyopia↗