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Food and Drug Administration study update. One-year results from 671 patients with the 3M multifocal intraocular lens.

PURPOSE/BACKGROUND: The clinical evaluation of the Food and Drug Administration study of the 3M diffractive multifocal intraocular lens (IOL) is presented here to demonstrate the results of 1-year postoperative data accumulated for 671 patients, the first of whom received the implant in 1987. METHODS: Patients were selected for study if they had absence of preoperative pathology, were at least 60 years of age, and had a reasonable postoperative prognosis. Extensive evaluations took place at 4 to 6 months and 12 to 14 months after surgery, including five different visual acuity measurements and contrast sensitivity. All testing was completed on both eyes. Data from the fellow eye served as a control when implanted with a monofocal IOL. RESULTS: Overall uncorrected distance visual acuity at 1 year after surgery shows 57% patients with 20/40 or better acuity. In this same group, 78% achieved J3 or better near vision, which improved to 82% in the best case group. Uncorrected visual acuity of 20/40 or better and J3 or better was achieved by 50% of best case multifocal IOL patients, compared with 26% of the monofocal best case comparison group. Measurements of contrast sensitivity consistently document a small loss, which is considered clinically insignificant. Statistical analysis of satisfaction ratings shows that predictors of satisfaction include uncorrected distance acuity, final near acuity, and fellow eye spherical equivalent. CONCLUSION: This multifocal lens appears to work very well for most patients, with more than half having functional uncorrected distance and near vision. The study showed several considerations that are important for optimizing clinical performance and patient satisfaction: patient selection, realistic expectations, accurate biometry, and adequate control of surgical procedures.

Aged↗

Fetal size and growth.

Prior to the introduction of ultrasound, Nägele's rule was the primary method for determining gestational age. Ultrasound has enabled a more accurate estimation of gestational age, allowing for improved detection of the fetus who is small for gestational age and reducing the number of women who are diagnosed as being overdue. The latest biometry charts that can be used for assessment of growth and dating are reviewed. It has long been recognized that a small or growth-retarded fetus has much greater short-term morbidity and mortality compared with its normal counterpart. More recently, the long-term sequelae of this condition are being recognized, illuminating the importance of the prevention and prediction of pregnancies with fetal growth problems. By focusing on better education and nutrition to prevent pregnancies at risk of becoming growth retarded and by using ultrasound to predict and manage these cases, we can improve the outcome for this group of patients.

Abdomen↗

[Significance of doppler ultrasound examination in successful termination of pregnancy with arterial hypertension in the course of chronic proliferative glomerulonephritis].

Diagnostic and therapeutic management in pregnant woman with severe arterial hypertension in course of glomerulonephritis proliferativa chronica at kidney insufficiency stage was presented. Ultrasonic biometry, biophysical fetal profile and Doppler ultrasound velocimetry were performed for antenatal fetal surveillance. Relation between a degree of fetal compromise (abnormal qualitative Doppler velocimetry indices and pre-pathological or even pathological NST) and a long-drawn increase of both diastolic and systolic blood pressure was stated. Doppler ultrasound examination gave possibility of monitoring and evaluation of fetal distress and verification of its treatment efficacy, what would allow to prolong the pregnancy for 12 days and was a definite contribution to its successful outcome.

Abortion, Induced↗

Characterization of Paraguayan Trypanosoma cruzi strains isolated from acute patients of Chagas disease.

Five Paraguayan Trypanosoma cruzi strains, isolated from acute chagasic patients, were studied by their behavior in BALB/c mice, metacyelogenesis, bio-metry of metacyclic forms and lectin agglutination. Early and intermediate parasitemic peaks were observed and the strains did not show high virulence. Metacyclogenesis capacity was not higher than 50% in all cases and there were no considerable differences in the biometry. They all belong to WGA-type strains according to the lectin agglutination assays except for one strain that agglutinated with WGA and PNA lectins. Although previous schizodeme analysis of these strains showed rather homogeneous profiles, biological features were quite heterogeneous.

Agglutination Tests↗

Metachronanalysis of circannual and circasemiannual characteristics of human suprachiasmatic vasopressin-containing neurons.

We here test for and detect anticipated about-yearly (circannual) changes in the volume and number of vasopressin-containing neurons in the human suprachiasmatic nucleus. We then resolve inferential statistical parameters quantifying the extent and timing (the amplitude and acrophase) of the circannual rhythm previously missed by data inspection and classical biometry. We parametrize about-half-yearly changes previously validated by non-parametric statistical tests. New dynamic circannual and circasemiannual endpoints thus become available for basic investigation and the assessment of disease risk elevation and/or chronoprotopathology. It was earlier demonstrated that the circannual rhythms of prolactin and TSH are prominent classifiers of individuals at high versus low familial and other risk for developing breast or prostate cancer. Any neurocrine or neural mechanisms contributing to this classification are now amenable to study, on a population basis, with the dynamic hypothalamic rhythm characteristics yielded by this metachronanalysis.

Cell Count↗

[Comparative value of transverse abdominal diameter and fetal abdominal perimeter. 3844 biometric examinations].

OBJECTIVE: Assess charts of abdominal size as they are used in a routine ultrasound screening, on a non selected population with 5 operators, to compare the interest of transverse abdominal diameter (TAD) with abdominal circumference (AC). METHOD: Retrospective study, in the department of Antenatal Diagnosis of the Centre Médico-Chirurgical et Obstétrical between September 1991 and August 1994. MAIN OUTCOME MEASURES: Abdominal biometry and gestational age to characterize the prenatal trophicity. Neonatal weight and gestational age at birth to characterize neonatal trophicity. RESULTS: Between 32 and 36 weeks, the TAD charts detected only one SGA (small for gestational age) out of 10. However, the AC sensitivity was 54.5% with a specificity of 94%. In the same period, the TAD charts suspect LGA (large for gestational age) for one exam out of two. The charts of AC have about the same performance to detect LGA and SGA. CONCLUSION: For a routine ultrasound screening between 32 and 36 weeks gestational age, the AC charts have to be preferred to TAD charts.

Abdomen↗

[Ultrasonic screening of pregnant teenagers].

Ultrasonography was applied to investigate 218 pregnant girls aged 11 to 16 for a period of 6 years, 70 of whom were examined in the first trimester and 148--in the second and third trimester. The girls presented the following disturbances: bleeding, expected premature birth, complications of pregnancy such as preeclampsia-eclampsia, suspected pelvio-fetal disproportions. Standard biometry was applied using automatic recording of body weigh by the formula of Campel. Missed abortion was diagnosed in 10 patients in the first trimester and 12 were found with blighted ovum. Ultrasound screening and cardiotocography are the most reliable to examine the status of the fetus.

Adolescent↗

[Methods of the study of basal lacrimal secretion].

The authors propose a nontraditional method for the study of basal lacrimal secretion, based on biometry of the height of the lacrimal flow meniscus during common biomicroscopy. The advantages of this method are shown: it is noninvasive, contact-free, available, and informative for assessing basal lacrimal secretion. The authors defined the normal value of lacrimal meniscus height in health and detected noticeable changes of basal secretion in secondary dry syndrome. Basal lacrimal secretion is suppressed in patients with pathologic changes of the anterior segment of the eye (relapsing erosions, pterygium, chronic conjunctivitis in contact correction, etc.). Prospects for practical use of the method are outlined.

Adolescent↗

The central oxytocin pulse generator: a pacemaker for luteolysis.

Oxytocin (OT) is released from the neurohypophysis into the jugular vein of sheep in small 1-2 min pulses (ca. 10 pg/ml) in both cyclic and ovariectomized sheep. In intact cycling sheep, additional hour long bursts of OT (up to 200 pg/ml) occur in peripheral blood during luteolysis at intervals of 6 to 9 hrs which appear to regulate large luteolytic pulses of uterine prostaglandin F2a (PGF2a). Since the ovine corpus luteum (CL) also synthesizes OT, experiments were performed to distinguish between the relative contributions of the neurohypophysis and the CL to the large bursts of OT secreted during luteolysis. Two models were used. First, ovariectomized sheep were given exogenous E and/or P by constant infusion to simulate levels during the estrous cycle. Second, in tact cycling sheep, the CL was surgically excised during the luteal phase to exclude the CL as a source of OT and, at the same time, subject the animals to the withdrawal of P. Pulses of OT in jugular vein plasma were determined by RIA or biometry of the uterus. The findings are summarized as follows: In ovariectomized sheep, maintained on low E (0.05 g/hr) to preserve the OT pulse generator, infusion of E (1 microgram, 2 micrograms or 4 micrograms/hr) for 12 to 36 hr, caused a series (4 to 6) of rapid increases in OT pulse frequency each lasting 1 to 2 hrs at intervals of 3 hrs. The time of onset of high frequency pulses was dose-dependent. Withdrawal of 10 day infusions of P (500 micrograms/hr) superimposed on low E (0.05 microgram/hr) also evoked a series of high frequency episodes of OT pulses beginning 24 hrs after P withdrawal. In intact sheep, surgical removal of the CL resulted in a series of high frequency pulses similar in duration and frequency to those following the withdrawal of P in the ovariectomized animal. We conclude that: (1) an increase in E or returning E action causes the OT pulse generator to alter its frequency intermittently thus producing a series of 4 to 6 episodes of high frequency pulses of OT. (2) Similar changes can be evoked by withdrawal of P either by terminating an infusion of P in the presence of E in the ovariectomized sheep or by surgically removing the CL from the ovary in the intact sheep. (3) At the end of the reproductive cycle, the central OT pulse generator appears to act as a pacemaker which, acting on the endometrial OT receptors, triggers a series of pulses of PGF2a from the uterus and hence causes regression of the CL. In the sheep and other ruminants, an intermittent supplemental secretion of OT from the CL, triggered via the central OT pulse generator, may also be required to amplify the luteolytic pulses of PGF2a from the uterus. (4) In addition to the well established interaction of ovarian steroid hormones, and the hypothalamic pituitary system for the initiation of the reproductive cycle via the gonadotrophins, there is now good evidence for an interaction of ovarian steroids and the posterior pituitary for terminating the reproductive cycle.

Animals↗

Sonography in the evaluation of the cervix during pregnancy.

Sonographic techniques have been developed to study the biometry and behavior of the cervix during pregnancy which have led to a better understanding of the pathogenesis of pregnancy loss and preterm birth. Nomograms have been developed for singleton and twin gestations, and associations between cervical sonographic characteristics and various adverse pregnancy outcomes have been observed. The new concept of 'relative' cervical incompetence suggests that the cervix may be an independent contributor to preterm birth. The incorporation of cervical sonography in management schemes for the prevention of pregnancy loss or preterm delivery has the potential to impact favorably on perinatal outcome.

Cervix Uteri↗

[Progress of labor and neonatal morbidity in primiparity with breech presentation].

Progress of labour in 100 consecutively delivered term ( > or = 37 weeks) primiparous breech births was analysed and correlated with fetal outcome according to different durations of first and second stages. All women had sonographic biometry prior to admission and epidural anaesthesia (PDA) early in established labour. Women with nonreassuring fetal heart rate tracings during any stage of labour were delivered by caesarean section, and were excluded. Birth weights were between 1980 g and 4090 g. There was no perinatal mortality, but eight neonates sustained birth associated trauma (6 Erb's palsies, two fractured long bones), all of which regressed spontaneously. Risk of neonatal trauma and of reduced Apgar scores was significantly associated with duration of the first stage but not of the second stage. It appears that short first stage duration (i.e. up to six hours) or a cervical dilatation rate of no less than 1 cm/h is associated with a very low risk of fetal trauma. In contrast, no upper limit of a second stage duration associated with low trauma risk could be seen in this group of parturients with effective continuous epidural anaesthesia. Assumptions regarding risks in primiparous labour progress for term breech labour may need to be reevaluated. The data presented are suitable for comparison with those from other centres and for metaanalyses.

Adult↗

MR determination of hippocampal volume: comparison of three methods.

PURPOSE: To determine whether measurements of the volume of the hippocampal formation obtained from a three-dimensional acquisition not perpendicular to the hippocampus are statistically different from those obtained from a perpendicular acquisition. METHODS: Both hippocampi were studied in 10 healthy volunteers with two three-dimensional acquisitions, allowing three different volume-calculation protocols: (a) on sections from a coronal 3-D acquisition not perpendicular to the axis of the hippocampal formation (NOPERP protocol), (b) on sections obtained with the same acquisition but reformatted perpendicular to the axis of the hippocampal formation (REFOR protocol), and (c) on sections from a coronal 3-D acquisition perpendicular to the axis of the hippocampal formation (PERP protocol) obtained with the patient's head tilted backward. To obtain measurements of the volume of the hippocampal formations, an accurate 3-D processing technique was used to segment the hippocampus. In all subjects, two hippocampal formation right-left asymmetry indexes were calculated by using each of the three protocols. RESULTS: For the right hippocampus, the mean volume was 3.42 cm3 (NOPERP protocol), 4.18 cm3 (REFOR protocol), and 3.91 cm3 (PERP protocol). For the left hippocampus, the mean volume was 3.29 cm3 (NOPERP protocol), 4.02 cm3 (REFOR protocol), and 3.74 cm3 (PERP protocol). For both hippocampi, the differences of the mean volumes were significant between each protocol. However, for both hippocampi, a high correlation was observed between volumes obtained with the different protocols. For the two asymmetry indexes, there were no significant differences for the means obtained with the three protocols. CONCLUSION: With the use of 3-D acquisitions in the study of hippocampal formation biometry, different procedures lead to significant variations in the absolute values of the volume of the hippocampal formation. However, there is a strong correlation between the results obtained by each method.

Adult↗

[Form deprivation myopia caused by keratitis scrophulosa].

Zrenner and Schaeffel reported that translucent occluders may induce axial eye elongation in animals. This axial growth is also called form deprivation myopia (FDM). Searching for a clinical correlate we examined in a retrospective study 115 patients with keratitis scrophulosa peracta, mainly corneal transplant patients. These patients had an average refraction of -4.27 dpt. In epidemiologic studies Stenström found +0.5 dpt as the mean refraction in the general population. When the onset of the corneal disease was before the age of 5 years, the myopia was found to be higher than in patients with later age of onset. In 43 patients we determined axial length by ultrasound biometry and found an average axial length of 26.89 mm, whereas the general average is 24.00 mm. In conclusion, these results confirm that not only in animal experiments but also in clinical cases FDM is responsible for the axial growth of eyes.

Adolescent↗

High-volume intraocular lens surgery in a rural eye camp in India.

BACKGROUND AND OBJECTIVE: The appropriate surgical treatment for the enormous number of patients in developing nations who are blind due to cataract is a hotly debated issue. The authors objective is to demonstrate that modern surgical techniques (extracapsular cataract extraction and intraocular lens implantation, phacoemulsification and intraocular lens implantation) can be performed in a high-volume, cost effective manner, even in temporary settings. The authors believe that the approach to cataract blindness is not simple intracapsular cataract extraction, but rather the challenge of (1) training all ophthalmic personnel in modern techniques (microsurgery, biometry), (2) training managers in higher levels of organizational skill, and (3) doing these things in the face of limited resources. PATIENTS AND METHODS: A total of 1298 surgeries were performed in a public eye camp in Ganeshpuri, India (50 miles north of Bombay). Of these, 1214 (93.5%) of the patients received intraocular lens (IOL) implants. Ninety-three percent (1032/1108) of the patients who underwent extracapsular cataract extraction (ECCE) and IOL implantation and 89% (83/93) of the patients who underwent phacoemulsification and IOL implantation returned for follow-up. RESULTS: Postoperatively, 48% (498/1032) of the patients who underwent ECCE and IOL implantation achieved corrected vision of 6/12 or better and 65% (671/1032) attained corrected vision of 6/18 or better. Of the patients who underwent phacoemulsification and IOL implantation, 59 of 83 (71%) attained vision of 6/12 or better with correction and 68 of 83 (79%) achieved vision of 6/18 or better with correction. These results are almost identical to those obtained by the authors in their Ganeshpuri 1991 camp. Surgical complication rates were comparable to those reported in hospital-based studies. CONCLUSION: For this type of camp to operate efficiently, there must be standardization of skills among ophthalmic personnel, costs must be contained, and the organizational skills necessary to ensure smooth functioning of the camp must exist. However, on the basis of their data, these authors believe that with suitable organizational and surgical facilities, IOL implantation can be successfully performed in high-volume surgical eye camps.

Blindness↗

Development of a comprehensive nursing/toxicity assessment form.

PURPOSE/OBJECTIVES: To develop and implement a form that integrates nursing and clinical trials toxicity assessments and interventions. DATA SOURCES: Published books, journal articles, and toxicity scales. DATA SYNTHESIS: The combined nursing and biometry department Documentation/Toxicity Committee at the London Regional Cancer Centre designed and implemented the comprehensive Patient Assessment Record (PAR) to provide consistent nursing and toxicity data related to patients enrolled in clinical trials research protocols. Nursing interventions and evaluations are documented on the Nursing Intervention Record (NIR). CONCLUSIONS: Initial evaluation suggested that the PAR has been an effective form. Audit results indicated that the form minimizes the number of individuals collecting the same data while maintaining the quality of toxicity data. IMPLICATIONS FOR NURSING PRACTICE: The collection of toxicity data for patients enrolled in clinical trials protocols has been incorporated into primary nurses' job descriptions. This additional responsibility has enhanced their role. Both the PAR and the NIR have assisted the multidisciplinary teams in meeting their documentation needs.

Antineoplastic Agents↗

[The results of correcting aphakia by an artificial lens implant].

The author shows the efficacy of correction in aphakia by intraocular lenses in the absence of ocular biometry and using of viscoelastic substance on a group of 258 cases hospitalised and operated in the Department of Ophthalmology of the University of Medicine from Cluj-Napoca. The study includes also the immediate and late complications of intraocular lenses and causes for removal of intraocular lens.

Adolescent↗

[Labor induction with extra-amnial administration of PGE2 vaginal tablets].

UNLABELLED: During the period between Jan. 1 1992 and Dec. 31, 1995 at the Second Department of Gynaecology and Obstetrics in Brno labour was induced in 1159 patients by extraamnial fractionated administration of PGE2 vaginal tablets. After assessment of the indication and the baseline examination (NST, amnioscopy, US biometry and cervical score) according to the CS to the patient the first dose of PGE2 was administered into the extraamnial space beyond the inner os uteri (CS 5-8:1.0 mg PGE2, CS > 8 : 0.5 mg PGE2). After two hours the patient was examined again and if regular uterine contractions had started or the finding on the os uteri was larger than 2 cm, the amniotic sac was disrupted. If not, another dose was administered. After two hours the patient was re-examined and if the os was larger than 2 cm, and there were regular uterine contractions, the amniotic sac was disrupted. If the changes did not take place, the induction was considered a failure. RESULTS: there were 1007 successful inductions (95.5%), the mean period from the onset of induction to the onset of uterine contractions was < 120 mins-269 (24.6%), 120-180 mins.: 501 (45.9%) and > 180 mins.: 322 (29.5%). The mean period of the first stage of labour was 228 mins., stage II 10 mins., stage III 8 mins. Five times uterine hypertonus was recorded and a blood loss greater than 500 ml occurred in four patients. Forty-nine Caesarean sections were made (4.2%) and 51 (4.4%) forceps deliveries. The rate of epidural analgesia was 27 (2.3%). Revision of the uterine cavity was made in 39 patients (3.4%) and manual lysis of the placenta in 30 (2.6%). The Apgar score was inferior to 6 in 10 neonates (0.9%). The protocol of induction of labour described by the authors is effective and associated with a minimum of side-effects, safe for the mother and foetus, well tolerated by patients and cost-effective.

Dinoprostone↗

Combined pars plana vitrectomy, phacoemulsification, and intraocular lens implantation in the capsular bag: a comparison to vitrectomy and subsequent cataract surgery as a two-step procedure.

BACKGROUND AND OBJECTIVE: To evaluate the effectiveness and safety of combined surgery. PATIENTS AND METHODS: Combined surgery (CS) consisting of pars plana vitrectomy (PPV), phacoemulsification, and implantation of a posterior chamber intraocular lens (PC IOL) in the capsular bag was performed on 26 patients. Another 26 had phacoemulsification with PC IOL insertion one to 84 months (mean 17.3) after PPV (sequential surgery, SS). Mean follow-up was 21.9 months after CS and 19.5 months after the cataract surgery in the SS group. The data were analyzed in a prospective, nonrandomized fashion. RESULTS: Visual acuity and refraction, astigmatism, accuracy of biometry, intraocular pressure, intraoperative, postoperative and long-term complications, and medical treatment were comparable in the two groups. Among the four uveitis patients in each group, transient fibrin formation was more frequent with CS (100%) than with SS (25%). The advantages of CS are that only one operation is needed, intraoperative working conditions are good, macular recovery is not masked by postvitrectomy cataract formation, and ideal lens centration is achievable. Potential disadvantages of CS include a longer operative time and increased technical demand, shrinkage of the anterior capsular opening, which may interfere with fundus view, and increased inflammation may be seen in patients with preexisting uveitis. CONCLUSION: Combined surgery in selected patients is a safe and effective approach, and outcomes are comparable to sequential surgery.

Adult↗