Dermoscopic and clinical predictors of reflectance confocal microscopy patterns of typical nevi on the back and legs: A cross-sectional study.

BACKGROUND: Nevus phenotype is a marker of melanoma risk. In vivo prediction of microscopic pattern is needed to more precisely classify nevi. OBJECTIVE: To identify dermoscopic and clinical predictors of microscopic patterns of typical nevi. METHODS: We used reflectance confocal microscopy (RCM) to classify microscopic patterns of nevi. We prospectively accrued adults presenting for periodic skin screening and imaged, with dermoscopy and RCM, 3 randomly selected nevi from the upper and lower back and lower extremity. RCM patterns were classified into ring, clod, meshwork, and composite types. Logistic regression was used to identify best predictors of RCM pattern. RESULTS: The study included 310 nevi from 112 participants (mean age 44 years; 51 women). Dermoscopic reticular pattern correlated most frequently (59.9%) with RCM ring pattern, dermoscopic globular with RCM composite (56.6%) and RCM clod (35.9%), dermoscopic complex with RCM composite (76.3%), and dermoscopic homogenous with RCM clod (50.8%). Integrating dermoscopic pattern with contour, diameter, color, and anatomic location of nevi improved prediction of microscopic patterns beyond dermoscopy alone. The dermoscopic clinical regression model correctly classified lesions to RCM ring versus RCM clod in 90% and to RCM ring versus RCM composite patterns in 81%. LIMITATIONS: The study was restricted to adults, back and lower extremities, and typical nevi. CONCLUSIONS: Integrating dermoscopic patterns with clinical attributes may improve prediction of microscopic patterns of nevi.

Enzymatic MPG DNA repair assays for two different oxidative DNA lesions reveal associations with increased lung cancer risk.

DNA repair is a major mechanism for minimizing mutations and reducing cancer risk. Here, we present the development of reproducible and specific enzymatic assays for methylpurine DNA glycosylase (MPG) repairing the oxidative lesions 1,N6-ethenoadenine (εA) and hypoxanthine (Hx) in peripheral blood mononuclear cells protein extracts. Association of these DNA repair activities with lung cancer was determined using conditional logistic regression with specimens from a population-based case-control study with 96 lung cancer cases and 96 matched control subjects. The mean MPG-εA in case patients was 15.8 units/µg protein (95% CI 15.3-16.3), significantly higher than in control subjects-15.1 (14.6-15.5), *P = 0.011. The adjusted odds ratio for lung cancer associated with a one SD increase in MPG-εA activity (2.48 units) was significantly bigger than 1 (OR = 1.6, 95% CI = 1.1-2.4; *P = 0.013). When activity of OGG1, a different DNA repair enzyme for oxidative damage, was included in the model, the estimated odds ratio/SD for a combined MPG-εA-OGG1 score was 2.6 (95% CI 1.6-4.2) *P = 0.0001, higher than the odds ratio for each single assay. The MPG enzyme activity assays described provide robust functional risk biomarkers, with increased MPG-εA activity being associated with increased lung cancer risk, similar to the behavior of MPG-Hx. This underscores the notion that imbalances in DNA repair, including high DNA repair, usually perceived as beneficial, can cause cancer risk. Such DNA repair risk biomarkers may be useful for risk assessment of lung cancer and perhaps other cancer types, and for early detection techniques such as low-dose CT.

Co-occurrence of transcription and translation gene regulatory features underlies coordinated mRNA and protein synthesis.

BACKGROUND: Variability in protein levels is generated through intricate control of the different gene decoding phases. Presently little is known about the links between the various gene expression stages. Here we investigated the relationship between transcription and translation regulatory properties encoded in mammalian genes. RESULTS: We found that the TATA-box, a core promoter element known to enhance transcriptional output, is associated not only with higher mRNA levels but also with positive translation regulatory features and elevated translation efficiency. Further investigation revealed general association between transcription and translation regulatory trends. Specifically, translation inhibitory features such as the presence of upstream AUG (uAUG) and increased lengths of the 5'UTR, the coding sequence and the 3'UTR, are strongly associated with lower translation as well as lower transcriptional rate. CONCLUSIONS: Our findings reveal that co-occurrence of several gene-encoded transcription and translation regulatory features with the same trend substantially contributes to the final mRNA and protein expression levels and enables their coordination.

The role of statisticians in the response to COVID-19 in Israel: a holistic point of view.

The COVID-19 pandemic cast a dramatic spotlight on the use of data as a fundamental component of good decision-making. Evaluating and comparing alternative policies required information on concurrent infection rates and insightful analysis to project them into the future. Statisticians in Israel were involved in these processes early in the pandemic in some silos as an ad-hoc unorganized effort. Informal discussions within the statistical community culminated in a roundtable, organized by three past presidents of the Israel Statistical Association, and hosted by the Samuel Neaman Institute in April 2021. The meeting was designed to provide a forum for exchange of views on the profession's role during the COVID-19 pandemic, and more generally, on its influence in promoting evidence-based public policy. This paper builds on the insights and discussions that emerged during the roundtable meeting and presents a general framework, with recommendations, for involving statisticians and statistics in decision-making.

Analysis of chemotaxis when the fraction of responsive cells is small--application to mammalian sperm guidance.

The detection of chemotaxis-related changes in the swimming behavior of mammalian spermatozoa in a spatial chemoattractant gradient has hitherto been an intractable problem. The difficulty is that the fraction of responsive cells in the sperm population is very small and that the large majority of the cells, though non-responsive, are motile too. Assessment of the chemotactic effects in a spatial gradient is also very sensitive to the quality of sperm tracking. To overcome these difficulties we propose a new approach, based on the analysis of the distribution of instantaneous directionality angles made by spermatozoa in a spatial gradient versus a no-gradient control. Although the use of this parameter does not allow identification of individual responding cells, it is a reliable measure of directionality, independent of errors in cell tracking caused by cell collisions, track crossings, and track splitting. The analysis identifies bias in the swimming direction of a population relative to the gradient direction. It involves statistical chi2 tests of the very large sample of measured angles, where the critical chi2 values are adjusted to the sample size by the bootstrapping procedure. The combination of the newly measured parameter and the special analysis provides a highly sensitive method for the detection of a chemotactic response, even a very small one.

Development of an enzymatic DNA repair assay for molecular epidemiology studies: distribution of OGG activity in healthy individuals.

While the role of reduced DNA repair in susceptibility to hereditary cancers is well established, its role in sporadic cancer is less understood. One of the reasons is the lack of specific DNA repair assays that are suitable for epidemiology studies. Here we describe the development of the OGG test, an epidemiology-grade enzymatic assay for the activity of the base excision repair enzyme 8-oxoguanine DNA glycosylase, in protein extracts prepared from human blood cells. The assay is robust and reproducible, with a coefficient of variation of 10%. Using the OGG test we determined OGG activity in 120 healthy individuals. Our results show an inter-individual variation of 2.8-fold in OGG activity, from 3.6 up to 10.1units/microg protein, with a mean value of 7.2units/microg protein. There was no significant difference in OGG activity between males and females, or between smokers and non-smokers. Interestingly, there was a gender-specific effect of age: OGG activity was slightly but significantly lower in males older than the age of 55 years compared to younger males, but not in females at the same age groups. Analysis of OGG1 mRNA by quantitative real-time RT-PCR showed a group trend of an increase in OGG enzymatic activity with increasing mRNA expression, but the correlation between activity and mRNA in individuals was poor, indicating the importance of factors other than mRNA expression. The OGG test described is expected to be useful in studying the role of 8-oxoguanine repair in cancer, as recently demonstrated for non-small cell lung cancer [T. Paz-Elizur, M. Krupsky, S. Blumenstein, D. Elinger, E. Schechtman, Z. Livneh, J. Natl. Cancer Inst. 95 (2003) 1312-1319]. In addition, it may serve as a paradigm for the development of additional functional DNA repair tests, which are needed in order to gain further insight into the role of DNA repair in cancer risk and pathology.

A method with flexible and balanced control of false negatives and false positives for hit selection in RNA interference high-throughput screening assays: a statistical terminology.

Zhang suggests a new method that is flexible and controls the balance between false negatives and false positives for hit selection in RNA high-throughput screening assays. The author shows that the same decision rules and balances can be expressed by familiar statistical terms such as type I error and power and hence connects the new method to known statistical tools. (Journal of Biomolecular Screening 2008:309-311).

Reduced repair of the oxidative 8-oxoguanine DNA damage and risk of head and neck cancer.

An increasing number of studies indicate that reduced DNA-repair capacity is associated with increased cancer risk. Using a functional assay for the removal of the oxidative DNA lesion 8-oxoguanine by the DNA-repair enzyme 8-oxoguanine DNA glycosylase 1 (OGG1), we have previously shown that reduced OGG activity is a risk factor in lung cancer. Here, we report that OGG activity in peripheral blood mononuclear cells from 37 cases with squamous cell carcinoma of the head and neck (SCCHN) was significantly lower than in 93 control subjects, frequency matched for age and gender. Retesting of OGG activity 3 to 4 years after diagnosis and successful treatment of 18 individuals who recovered from the disease showed that OGG activity values were similar to those determined at diagnosis, suggesting that reduced OGG activity in case patients was not caused by the disease. Logistic regression analysis indicated that the adjusted odds ratio (OR) associated with a unit decrease in OGG activity was statistically significantly increased [OR, 2.3; 95% confidence interval (95% CI), 1.5-3.4]. Individuals in the lowest tertile of OGG activity exhibited an increased risk of SCCHN with an OR of 7.0 (95% CI, 2.0-24.5). The combination of smoking and low OGG was associated with a highly increased estimated relative risk for SCCHN. These results suggest that low OGG is associated with the risk of SCCHN, and if confirmed by additional epidemiologic studies, screening of smokers for low OGG activity might be used as a strategy for the prevention of lung cancer and SCCHN.

Correlation and the time interval over which the variables are measured - A non-parametric approach.

It is known that when one (or both) variable is multiplicative, the choice of differencing intervals (n) (for example, differencing interval of n = 7 means a weekly datum which is the product of seven daily data) affects the Pearson correlation coefficient (ρ) between variables (often asset returns) and that ρ converges to zero as n increases. This fact can cause the resulting correlation to be arbitrary, hence unreliable. We suggest using Spearman correlation (r) and prove that as n increases Spearman correlation tends to a limit which only depends on Pearson correlation based on the original data (i.e., the value for a single period). In addition, we show, via simulation, that the relative variability (CV) of the estimator of ρ increases with n and that r does not share this disadvantage. Therefore, we suggest using Spearman when one (or both) variable is multiplicative.

Driver views on speed and enforcement.

This paper reports on the results of a drivers' survey regarding the effects of speed cameras for speed enforcement in Israel. The survey was part of a larger study that accompanied the introduction of digital speed cameras. Speed camera deployment started in 2011, and till the end of 2013 twenty-one cameras were deployed in interurban road sections. Yearly surveys were taken between 2010 and 2013 in 9 gas stations near speed camera installation sites in order to capture drivers' opinions about speed and enforcement. Overall, 1993 drivers were interviewed. In terms of admitted speed behavior, 38% of the drivers in 2010, 21% in 2011, 13% in 2012 and 11% in 2013 reported that their driving speed was above the perceived posted speed limit. The proportion of drivers indicating some speed camera influence on driving decreased over the years. In addition, the majority of drivers (61%) predicted positive impact of speed cameras on safety. This result did not change significantly over the years. The main stated explanation for speed limit violations was time pressure, while the main stated explanation for respecting the posted speed was enforcement, rather than safety concerns. Linear regression and sigmoidal models were applied to describe the linkage between the reported driving speed (dependent) and the perceived posted speed (independent). The sigmoidal model fitted the data better, especially at high levels of the perceived posted speeds. That is, although the perceived posted speed increased, at some point the actual driving speed levels off (asymptote) and did not increase. Moreover, we found that the upper asymptote of the sigmoidal model decreased over the years: from 113.22 (SE=18.84)km/h in 2010 to 88.92 (SE=1.55)km/h in 2013. A wide variance in perceived speed limits suggest that drivers may not know what the speed limits really are.

Parkinson disease (PARK) genes are somatically mutated in cutaneous melanoma.

OBJECTIVE: To assess whether Parkinson disease (PD) genes are somatically mutated in cutaneous melanoma (CM) tissue, because CM occurs in patients with PD at higher rates than in the general population and PD is more common than expected in CM cohorts. METHODS: We cross-referenced somatic mutations in metastatic CM detected by whole-exome sequencing with the 15 known PD (PARK) genes. We computed the empirical distribution of the sum of mutations in each gene (Smut) and of the number of tissue samples in which a given gene was mutated at least once (SSampl) for each of the analyzable genes, determined the 90th and 95th percentiles of the empirical distributions of these sums, and verified the location of PARK genes in these distributions. Identical analyses were applied to adenocarcinoma of lung (ADENOCA-LUNG) and squamous cell carcinoma of lung (SQUAMCA-LUNG). We also analyzed the distribution of the number of mutated PARK genes in CM samples vs the 2 lung cancers. RESULTS: Somatic CM mutation analysis (n = 246) detected 315,914 mutations in 18,758 genes. Somatic CM mutations were found in 14 of 15 PARK genes. Forty-eight percent of CM samples carried ≥1 PARK mutation and 25% carried multiple PARK mutations. PARK8 mutations occurred above the 95th percentile of the empirical distribution for SMut and SSampl. Significantly more CM samples harbored multiple PARK gene mutations compared with SQUAMCA-LUNG (p = 0.0026) and with ADENOCA-LUNG (p < 0.0001). CONCLUSIONS: The overrepresentation of somatic PARK mutations in CM suggests shared dysregulated pathways for CM and PD.

Drug identification performance on the basis of observable signs and symptoms.

A double blind study was performed to evaluate the ability of trained police officers to detect drug impairments and to identify the type of drug responsible for the impairment, on the basis of observed symptoms and psychophysical measurements of performance alone. The officers were not allowed to interview the subjects, and their conclusions were based solely on observable signs and symptoms on systematically measured vital signs, and on standardized sobriety tests of motor coordination. Results showed that with this partial information, the officers are able to detect drug impairment at better-than-chance levels with a sensitivity (correct detection of impairments) of 72%, but with a specificity of 43% (false alarm rate of 57%). Furthermore, the association between drug ingestion and identification of the specific impairing drug category was not very high, with sensitivities ranging from a low of 10% for amphetamine to a high of 49% for cannabis. Based on both sensitivity and specificity, drug identification was best for alprazolam impairment, noticeably poorer for cannabis and codeine impairment, and no better than chance for amphetamine impairment. Performance could have been improved if the officers were to list the two most probable impairing drugs (rather than limit their decision to only one), and if they were more consistent in their interpretation of observable signs and symptoms.

Modeling drug detection and diagnosis with the 'drug evaluation and classification program'.

In this study, we propose formal models and algorithms to detect drug impairment and identify the impairing drug type, on the basis of data obtained by a Drug Evaluation and Classification (DEC) investigation. The DEC program relies on measurements of vital signs and observable signs and symptoms. A formal model, based on data collected by police officers trained to detect and identify drug impairments, yielded sensitivity levels greater than 60% and specificity levels greater than 90% for impairments caused by cannabis, alprazolam, and amphetamine. For codeine, with a specificity of nearly 90% the sensitivity was only 20%. Using logistic regression, the formal model was much more accurate than the trained officers in identifying impairments from cannabis, alprazolam, and amphetamine. Both the formal model and the officers were quite poor in identifying codeine impairment. In conclusion, the joint application of the DECP procedures with the formal model is useful for drug detection and identification.

The effect of Center High Mounted Stop Lamp (CHMSL) on rear-end accidents in Israel.

This paper examines the effect of the use of Center High Mounted Stop Lamp (CHMSL) on rear-end accidents, as reflected in Israeli police records from calendar years 1991-2002. The basic analysis, similar to that used in previous CHMSL studies, compares the involvement in accidents of passenger cars of model years 1994-1996 that are equipped with CHMSL with passenger cars of model years 1991-1993 that are not equipped with CHMSL. The number of involvements as the struck vehicle in a rear-end accident was used as the relevant measurement and the number of involvements as the striking vehicle in a rear-end accident was used as the reference measurement. The results yielded an odds ratio of 0.93. The explanation that the CHMSL is responsible for the 7% decrease is intuitively appealing and is consistent with previous findings. However, the strength of this evidence is marginal (p = 0.07). Additional analyses evaluated the model year effect in greater detail, in order to determine whether there exists a change point between 1993 and 1994 as would be expected from a CHMSL effect, or whether the effect is spurious. Detailed analyses were performed on the ratio of struck to striking involvements as well as the rates of involvement of both types. These analyses showed that (1) the chosen reference measurement is an appropriate one, but (2) the 0.93 odds ratio is quite possibly due to other reasons unrelated to the CHMSL, thus further limiting the confidence in CHMSL effectiveness.

[Diabetic retinopathy following cataract surgery].

BACKGROUND: Approximately 20% of patients undergoing cataract surgery have diabetes mellitus. AIM: To evaluate the course of diabetic retinopathy after cataract surgery. METHODS: Diabetic patients with no or mild to moderate preoperative diabetic retinopathy were included and classified into 4 groups (A-D): A--The course of retinopathy, B--macular edema, C--the effect of voltaren ophtha eye drops and D--systemic glycemic control. Group E included eyes with previous laser treatment for proliferative retinopathy. Clinical and angiographic retinal findings were scored before and after surgery. Progression was defined as an increase in the retinal score. In groups A, C, D and E the non-operated eye served as a control. In group B, the eyes of nondiabetic patients who had undergone cataract surgery served as a control. RESULTS: Retinopathy was stable in 66% and progressed in 34% (p < 0.005). Progression occurred during the first 6 postoperative months in 84%. Preoperative retinopathy was a risk factor for progression. Good visual acuity was achieved in 67% and was correlated with: preoperative retinopathy and postoperative deterioration. Macular edema was found in 50% of eyes compared to 8% of the controls (p < 0.005). Its development was correlated with preoperative retinal status. Twenty six eyes were treated with voltaren eye drops and 24 with placebo. Progression of macular edema was seen less often in eyes treated with voltaren (p < 0.001). Deterioration of retinopathy was less common in cases when HbA1C was equal to or lower than 7.5 mg%. CONCLUSIONS: Close retinal follow-up after cataract surgery is recommended, especially in patients with preoperative diabetic retinopathy. Systemic control of diabetes and antiinflammatory eye drops may improve surgical results.

Estimating the risk for conversion from mild cognitive impairment to Alzheimer's disease in an elderly Arab community.

BACKGROUND: Vascular risk factors and lack of formal education may increase the risk of Alzheimer's disease (AD). OBJECTIVE: To determine the contribution of vascular risk factors and education to the risk of mild cognitive impairment (MCI) and AD and to estimate the risk for conversion from MCI to AD. METHODS: This door-to-door survey was performed by an Arab-speaking team in Wadi Ara villages in Israel. All consenting residents aged ≥ 65 years were interviewed for medical history and underwent neurological and cognitive examinations. Individuals were cognitively classified as normal (CN), MCI, AD, vascular dementia, or unclassifiable. MCI patients were re-examined at least one year later to determine conversion to AD. The contributions of age, gender, school years, and vascular risk factors to the probability of conversion were estimated using logistic regression models. RESULTS: Of the 906 participants, 297 (33%) had MCI and 95 (10%) had AD. Older age (p = 0.0008), female gender (p = 0.023), low schooling (p < 0.0001), and hypertension (p = 0.0002) significantly accounted for risk of MCI versus CN, and diabetes was borderline (p = 0.051). The risk of AD versus CN was significantly associated with age (p < 0.0001), female gender (p < 0.0001), low schooling (p = 0.004) and hypertension (p = 0.049). Of the 231 subjects with MCI that were re-examined, 65 converted to AD. CONCLUSIONS: In this population, age, female gender, lack of formal education, and hypertension are risk factors for both AD and MCI. Conversion risk from MCI to AD could be estimated as a function of age, time interval between examinations, and hypertension.

Pneumatic retinopexy: results in eyes with classic vs relative indications.

OBJECTIVE: To compare the results of pneumatic retinopexy in 3 groups of eyes with rhegmatogenous retinal detachment. METHODS: In this retrospective, consecutive study, 44 eyes of 44 patients who underwent pneumatic retinopexy were divided into 3 groups: eyes with vitreoretinal abnormalities (group A), pseudopakic or aphakic eyes (group B), and phakic eyes without vitreoretinal abnormalities (group C). RESULTS: Single retinopexy success was achieved in 10 (71%) of 14 eyes in group A, 7 (64%) of 11 eyes in group B, and 16 (84%) of 19 eyes in group C (P=.42). Final success after reoperation was achieved in 13 (93%) of 14 eyes in group A, 10 (91%) of 11 eyes in group B, and in all 19 eyes in group C (P=.44). In group B, the rate of single retinopexy success using cryotherapy was significantly higher (5/5; 100%) than when laser photocoagulation was used (1/5; 20%) (P=.015). The final visual outcome obtained in the 3 groups was similar. There were no significant intergroup differences in either early or late complications. CONCLUSIONS: The best results were achieved in eyes with classic indications for pneumatic retinopexy, though the differences between these results and those in the nonclassic indications were not significant. In pseudophakic or aphakic eyes, the rate of single operation success after cryopexy was significantly higher than the rate after laser photocoagulation.

Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization.

OBJECTIVE: Exploration of the possibility that local injury of the endometrium increases the incidence of implantation. DESIGN: Prospective study. SETTING: Clinical IVF unit. PATIENT(S): A group of 134 patients, defined as good responders to hormonal stimulation, who failed to conceive during one or more cycles of IVF and embryo transfer (ET). INTERVENTION(S): The IVF treatment and ET were preceded by repeated endometrial biopsies, in a randomly selected 45 of a total of 134 patients. MAIN OUTCOME MEASURES: Outcome of IVF-ET treatments. RESULT(S): Transfer of a similar number of embryos (3.4 +/- 1.0 and 3.1 +/- 0.9 in the experimental and control patients, respectively) resulted in rates of implantation (27.7% vs. 14.2%, P =.00011), clinical pregnancy (66.7% vs. 30.3%, P =.00009), and live births per ET (48.9% vs. 22.5%, P =.016) that were more than twofold higher in the experimental group as compared to controls. CONCLUSION(S): These results suggest that IVF treatment that is preceded by endometrial biopsy doubles the chance for a take-home baby.

Cabergoline, pramipexole and ropinirole used as monotherapy in early Parkinson's disease: an evidence-based comparison.

Dopamine agonists have been widely used as add-on to levodopa in the treatment of Parkinson's disease with motor fluctuations. However, the use of dopamine agonists in early Parkinson's disease and levodopa-naive patients is controversial. Although dopamine agonists have been compared with levodopa, no studies exist which directly compare one dopamine agonist with another. This evidence-based review compares the results of large published studies of early treatment of Parkinson's disease with dopamine agonists (cabergoline, ropinirole or pramipexole) with similar studies using levodopa. Because of their design, the common variables analysed in all studies were the proportion of patients who developed dyskinesia, those withdrawn from the trial and the mean change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III scores. Cabergoline, pramipexole and ropinirole were similarly effective in reducing the risk for dyskinesia relative to levodopa (p < 0.01 for all three). The reduction in risk for dyskinesia was slightly more evident for pramipexole and ropinirole (p < 0.0001) than cabergoline (p = 0.0074). Odds ratios (95% confidence intervals [CI]) relative to levodopa were 0.38 (0.19-0.78) for cabergoline, 0.25 (0.13-0.47) for pramipexole and 0.31 (0.18-0.53) for ropinirole. The absolute risk reductions (95% CI) were, respectively, 8% (2.2-13.7), 20% (11.7-29.8) and 25% (13.6-36.7), ropinirole reducing the risk significantly more than cabergoline. The mean change from baseline UPDRS was similar for pramipexole and ropinirole (not evaluated for cabergoline). The proportion of withdrawn patients and the adverse effect profiles of the three agonists were similar to each other, with the exception of oedema, which was less prominent for ropinirole than for the other two agonists. Cabergoline, pramipexole and ropinirole are comparable choices for the delay of dyskinesia. Their adverse effect profiles are also similar, but they are less well tolerated than levodopa. The motor antiparkinsonian benefit of dopamine agonists is somewhat smaller than that of levodopa.

Comparison of trabeculectomy with mitomycin C with or without phacoemulsification and lens implantation.

PURPOSE: To compare the results of combined trabeculectomy with phacoemulsification and posterior chamber intraocular lens (IOL) implantation to those of trabeculectomy alone using mitomycin C (MMC) application intraoperatively in all cases. PATIENTS AND METHODS: A retrospective comparative study of consecutive patients was conducted on two groups: 102 eyes of 90 patients studied in the combined procedure group, and 33 eyes of 30 patients in the trabeculectomy alone group. RESULTS: Both groups showed a significant decrease in IOP. The combined group had a change from 21.5+/-5.8 mm HG preoperative to 14.73+/-3.44 mm HG postoperative, P=0.0001; the trabeculectomy group changed from 24.2+/-7.5 mm HG preoperative to 12.46+/-3.86 mm HG postoperative, P=0.0001. This represents a 31.5% reduction in IOP in the combined group versus a 48.5% reduction in the trabeculectomy alone group (P=0.0001). The follow-up time was longer in the trabeculectomy group (trabeculectomy group, 22.6+/-13.3 months; combined group, 14.2+/-8.0 months), P=0.0014. There were 97 eyes in the combined group (95%) and 32 eyes (97%) in the trabeculectomy group that had an IOP of less than 20 mm HG at the end of follow up. Postoperatively, the two groups showed similar significant reductions in the number of antiglaucomatous medications used (combined group, 0.82+/-1.0 compared with 2.65+/-0.84 preoperatively, P=0.0001; trabeculectomy group, 0.76+/-1.2 compared with 2.7+/-0.95 preoperatively, P=0.0001). There were no cases of bleb leakage in the combined group and two cases (6%) in the trabeculectomy group. CONCLUSION: The reduction of IOP is significantly larger after trabeculectomy alone than after the combined procedure; however, the functional and anatomical results of the combined procedure of phacoemulsification, posterior chamber IOL implantation, and trabeculectomy with MMC application were as good as those of trabeculectomy alone with MMC.