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Abdulaziz Mohammad Al-Sharydah,1 Hussain Khalid Al-Arfaj,2 Sari Saleh Al-Suhibani,1 Fahad Safran Al-Safran,2 Abdulrahman Hamad Al-Abdulwahhab,1 Saeed Ahmad Al-Jubran,1 Abdulhadi Ahmad AlSaflan3 1Diagnostic and Interventional Radiology Department, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, Khobar City, Eastern Province, Saudi Arabia; 2Medical Imaging Department, King Fahd Specialist Hospital, Dammam City, Eastern Province, Saudi Arabia; 3Anesthesia Department, King Fahd Hospital of the University, Khobar City, Eastern Province, Saudi ArabiaCorrespondence: Abdulaziz Mohammad Al-Sharydah, Diagnostic and Interventional Radiology Department, Imam Abdulrahman Bin Faisal University, King Fahd Hospital of the University, P.O. Box: 31952 (4398), Khobar City, Eastern Province, Saudi Arabia, Tel +966 566473111, Fax +966 13-8676697, Email Amsharydah@iau.edu.saPurpose: Stroke is a leading cause of severe long-term disability and death worldwide. This study aimed to determine the genetic background, causative factors, and diagnostic and outcome measures of pediatric stroke in an area endemic to sickle cell disease (SCD).Patients and Methods: This retrospective review analyzed pediatric patients with acute stroke who were admitted to King Fahd Hospital of the University, Eastern Province, Saudi Arabia, between January and June 2019. We assessed 49 cases based on computed tomography (CT) and magnetic resonance imaging (MRI) findings. Patients with incomplete records or unavailable radiological images were excluded.Results: A high likelihood of familial coexistence of stroke was detected in patients with affected siblings (33%). Among various central nervous system manifestations, motor weakness (28.6%) and headache (20.4%) were the most common symptoms/signs. Hypoxic-ischemic encephalopathy (HIE) (28.6%), SCD (22.5%), and moyamoya disease (14.3%) were the most prevalent underlying etiologies. CT without intravenous contrast was the most used initial imaging technique (92.5%). An arterial blockage was more prevalent (53.4%) than a venous infarct (46.6%) (p = 0.041), while arterial ischemic stroke was more prevalent (56.5%) than hemorrhagic stroke (43.5%). The middle cerebral artery (MCA) was most affected (63.5%), followed by the anterior cerebral artery (22.7%) and posterior cerebral artery (13.6%). Most patients were managed with medical treatment (86.1%). No mortalities occurred during the initial hospital stay. The mean length of hospital stay was 12 days.Conclusion: HIE was the most prevalent etiology of pediatric stroke. Motor weakness and headache were the most common initial manifestations. Arterial ischemic stroke was more prevalent than venous or hemorrhagic stroke. Considering the rarity of pediatric stroke, future studies should be performed with a aborative effort nationally and internationally.Keywords: magnetic resonance imaging, computed tomography, ischemic stroke, hemorrhagic stroke, paediatric

Background Computers have become a fundamental part of clinical radiology departments. Radiologists tend to spend long hours in front of computers, reading and analyzing medical images. This prolonged use of computers is associated with digital eye strain. Therefore, this study aimed to estimate the prevalence of digital eye strain among radiologists and determine its contributory factors. Methods An online survey was sent to radiologists practicing in hospitals in the Eastern Province of Saudi Arabia. The survey addressed demographic information, workload and workstation environment, personal eye care, and evaluation of digital eye strain symptoms as well as the strategies employed to reduce these symptoms. Results were analyzed descriptively using Chi-square tests and logistic regression analyses. Results The survey was completed by 198 participants (111 men and 87 women), including residents (40.9%), senior registrars (27.3%), and consultants (27.3%). Most participants (71.2%) were aged below 40 years. Most participants tend to spend 7–9 hours daily reviewing medical images. Overall, 50 participants (25.3%) take a break from work once daily only. A total of 53 participants (26.8%) reported undergoing an eye examination within the past year and 100 participants (50.5%) reported experiencing digital eye strain. Multivariate logistic regression analysis revealed that female sex (odds ratio [OR] = 3.9; 95% confidence interval [95% CI]: 1.6–10.0) and the practice of taking breaks once a day (OR = 15.1; 95% CI: 2.4–94.1) or twice a day (OR = 5.5; 95% CI: 1.1–28.4) only were associated with higher rates of digital eye strain symptoms. Conclusion Digital eye strain is a prevalent condition among radiologists regardless of their subspecialty. It is more commonly seen among radiology residents. Being a female and not taking frequent breaks were associated with higher rates of digital eye strain.

Purpose To assess residents' performance of phacoemulsification surgery and determine which steps of the procedure are most difficult to learn, and to measure rate of intraoperative complications. Design This was a prospective observational study. Methods Phacoemulsification surgery was divided into steps and each step was given a proficiency grade by the attending consultant. All intraoperative complications were recorded and analyzed. Results 200 cases performed by the Eastern Province ophthalmology program residents were evaluated. The most commonly encountered difficulty factors were hard nucleus (20.7%), small pupil (12.6%), and white cataract (10.3%). Capsulorhexis, nucleus disassembly and removal, and cortex removal were the most difficult steps to learn. General complication rate was 17.5%, and posterior capsular rupture was the most common complication (40%). Proficiency more than 90% of the time in each step was noted in residents with prior experience of more than 40 cases, except for nucleus disassembly. Conclusion The study showed that nucleus disassembly remained the major obstacle in the residents' exponential learning curve of phacoemulsification surgery. Majority of complications occurred at level of capsulorhexis and cortical removal steps.

Functional magnetic resonance imaging (fMRI) is among the newest techniques of advanced neuroimaging that offer the opportunity for neuroradiologists, neurophysiologists, neuro-oncologists, and neurosurgeons to pre-operatively plan and manage different types of brain lesions. Furthermore, it plays a fundamental role in the personalized evaluation of patients with brain tumors or patients with an epileptic focus for preoperative planning. While the implementation of task-based fMRI has increased in recent years, the existing resources and evidence related to this technique are limited. We have, therefore, conducted a comprehensive review of the available resources to compile a detailed resource for physicians who specialize in managing patients with brain tumors and seizure disorders. This review contributes to the existing literature because it highlights the lack of studies on fMRI and its precise role and applicability in observing eloquent cerebral areas in surgical oncology and epilepsy patients, which we believe is underreported. Taking these considerations into account would help to better understand the role of this advanced neuroimaging technique and, ultimately, improve patient life expectancy and quality of life.

Rationale and objectives: Classifying brain tumors is challenging, but recently developed imaging techniques offer the opportunity for neuroradiologists and neurosurgeons to diagnose, differentiate, and manage different types of brain tumors. Such advances will be reflected in improvements in patients’ life expectancy and quality of life. Among the newest techniques, the apparent diffusion coefficient (ADC), which tracks the rate of microscopic water diffusion within tissues, has become a focus of investigation. Recently, ADC has been used as a preoperative diffusion-weighted magnetic resonance imaging (MRI) parameter that facilitates tumor diagnosis and grading. Here, we aimed to determine the ADC cutoff values for pediatric brain tumors (PBTs) categorized according to the World Health Organization (WHO) classification of brain tumors. Materials and methods: We retrospectively reviewed 80 cases, and assessed them based on their MRI-derived ADC. These results were compared with those of WHO classification-based histopathology. Results: Whole-lesion ADC values ranged 0.225–1.240 × 10−3 mm2/s for ependymal tumors, 0.107–1.571 × 10−3 mm2/s for embryonal tumors, 0.1065–2.37801 × 10−3 mm2/s for diffuse astrocytic and oligodendroglial tumors, 0.5220–0.7840 × 10−3 mm2/s for other astrocytic tumors, and 0.1530–0.8160 × 10−3 mm2/s for meningiomas. These findings revealed the usefulness of ADC in the differential diagnosis of PBT, as it was able to discriminate between five types of PBTs. Conclusion: The application of an ADC diagnostic criterion would reduce the need for spectroscopic analysis. However, further research is needed to implement ADC in the differential diagnosis of PBT. Keywords: Apparent diffusion coefficient, Differential diagnosis, Magnetic resonance imaging, Pediatric brain tumor

Purpose: To assess the visual outcomes, patient satisfaction and spectacle independence following implantation of new diffractive trifocal intraocular lenses. Setting: 2 centers (university-based practice and a private practice set up). Patients and methods: Prospective nonrandomized study in which 74 AT LISA TRI 839MP and 8 AT LISA TORIC TRI 939MP IOLs implanted bilaterally in 41 patients following either cataract extraction or refractive lensectomy, follow-up was done at 1st, 2nd and 3rd months to assess the visual and refractive outcomes. Also, a questionnaire was used to assess patient satisfaction, spectacle independence and photic phenomena after the surgery. Results: Mean uncorrected monocular distance decimal visual acuity (UDVA) was preoperatively 0.35. The averages of uncorrected monocular distance/intermediate/near (UDVA/UIVA/UNVA) postoperatively were 0.90/0.87/0.91 at 3 months. 87.5% patients had SE within ±0.50 by the 3rd month. Nearly all the patients were satisfied with the surgical outcome and the reported photic phenomena by some patients were non-disturbing with noticeable high level of patient’s satisfaction by the third month. Conclusion: Diffractive trifocal IOLs can provide with satisfactory visual and refractive results along with positive impact on the performance of vision-related daily activities with minimal level of non-disturbing photic phenomena to patients. Keywords: Trifocal IOLS, Visual outcomes, AT LISA, Diffractive IOLS, Intermediate vision

Purpose The aim of this study was to determine and relate corneal biomechanical metrics with demographic, tomographic and refractive data in healthy Saudi people. Design Prospective, cross-sectional, observational study. Participants The study included 215 normal Saudi adult individuals. Methods Corneal hysteresis (CH) and corneal resistance factor (CRF), Goldmann-correlated intraocular pressure (IOPg) and corneal-compensated intraocular pressure (IOPcc) were measured by ocular response analyzer. The central keratometry (CK), central corneal thickness (CCT), and anterior chamber depth (ACD) were measured using Pentacam system. The spherical equivalent of refraction (SER) was obtained by an Auto-refractometer. Results The mean CH was 11.16±2.11, CRF was 11.07±2.31 and IOP was 15.12±3.5. Mean CK, ACD, CH and CRF were distinct among gender with the significant P values of 0.05, 0.006, 0.020, and 0.047 respectively. CRF was negatively correlated with ACD ( r =−0.146, P =0.032). A positive correlation was found between CRF and SER ( r =0.176, P =0.010), CCT ( r =0.447, p =0.000) and CH ( r =0.878 and p =0.000). CH was negatively correlated with IOPcc (−0.433, p =0.000). A positive correlation was found between CH and ACD ( r =−0.14, p =0.044), SER ( r =0.617, p =0.014), CCT ( r =0.412, p =0.000) and IOPg ( r =0.183, p =0.007). Conclusion This study demonstrated a distinct difference among gender values of corneal hysteresis and corneal resistance factor being higher in female Saudi subjects. CH and CRF values were higher in Saudi subjects than values in other populations. This may suggest the presence of ethnic differences in ocular parameters and support the importance of establishing population norms for corneal biomechanical parameters.

We describe the case of a healthy 28-year-old woman who underwent implantation of a posterior chamber, phakic, toric, implantable Collamer lens (ICL) in both eyes for correction of bilateral high myopia with astigmatism. On the first postoperative day the patient developed increased intraocular pressure (IOP) and a fixed, mid-dilated pupil in her left eye. The elevated IOP was corrected within 3 days by medical treatment. However, the pupil remained mid-dilated and nonreactive to both light and accommodative effort during 2 months of follow-up; there was no reaction to pilocarpine (0.125% or 4%) eyedrops. The patient was diagnosed with Urrets-Zavalia syndrome (UZS), which has been reported in association with ICL implantation only once previously.

Objective To report the retention rate of the Boston keratoprosthesis type 1 and to identify risk factors for keratoprosthesis loss. Design Cohort study. Participants A total of 300 eyes of 300 patients who underwent implantation of the Boston keratoprosthesis type I device between January 2003 and July 2008 by 19 surgeons at 18 medical centers. Methods Forms reporting preoperative, intraoperative, and postoperative parameters were prospectively collected and subsequently analyzed at a central data collection site. Main Outcome Measures Keratoprosthesis retention. Results A total cumulative number of 422 life-years of device implantation are included in this analysis. The average duration of follow-up was 17.1±14.8 months, with a range of 1 week to >6.1 years. Ninety-three percent of the 300 Boston keratoprosthesis implants were retained at their last follow-up, corresponding to a retention time of 396 patient-years or 1.42 years/keratoprosthesis. The probability of retention after 1 year and 2 years was 94% and 89%, respectively. During the study period, 21 (7%) eyes failed to retain the device; the reasons for keratoprosthesis loss include sterile keratolysis (9), fungal infections (8), dense retroprosthetic membranes (3), and bacterial endophthalmitis (1). Multivariate analysis demonstrated 3 independent risk factors for keratoprosthesis loss: autoimmune cause (hazard ratio [HR], 11.94; 95% confidence interval [CI], 3.31–43.11), ocular surface exposure requiring a concomitant tarsorrhaphy (HR, 3.43; 95% CI, 1.05–11.22), and number of prior failed penetrating keratoplasties (HR, 1.64; 95% CI, 1.18–2.28). Conclusions The Boston keratoprosthesis type 1 seems to be a viable option for eyes that are not candidates for penetrating keratoplasty (PK). Ocular surface disease due to an autoimmune cause demonstrated the lowest retention rate. Financial Disclosure(s) The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Objective The purpose of this study was to identify possible risk factors for retroprosthetic membrane (RPM) development in a large, multicenter cohort of patients receiving a Boston type 1 keratoprosthesis. Design Cohort study. Participants The final analysis included 265 eyes of 265 patients who underwent implantation of a Boston keratoprosthesis type I device between January 2003 and July 2008 by 1 of 19 surgeons at 18 medical centers. Methods Forms reporting preoperative, intraoperative, and postoperative parameters were prospectively collected and subsequently analyzed at a central data collection site. Main Outcome Measures The primary outcome was the presence or absence of an RPM during the follow-up period. Results The average age of patients was 63.3±19.1 years, 48.5% of the patients were female, and 52.5% of procedures were performed on the right eye. The mean follow-up time was 17.8±14.9 months. The majority (85.4%; n=222) had undergone an average of 2.2±1.2 (range, 1–8) penetrating keratoplasties before keratoprosthesis implantation, and 38 eyes (14.6%) received a primary keratoprosthesis. The overall RPM formation rate was 31.7% (n = 84). The most significant risk factor for RPM development was infectious keratitis (as a surgical indication for keratoprosthesis surgery itself), resulting in a rate of RPM formation of 70.6%. As an independent risk factor, the hazard ratio (HR) of RPM development in these eyes was 3.20 (95% confidence interval, 1.66–6.17). Aniridia was also an independent risk factor for RPM development (HR, 3.13; 95% confidence interval, 1.10–8.89). Conclusions Formation of RPM is a common complication of keratoprosthesis surgery, occurring in approximately one-third of cases. Eyes at the highest risk of RPM development are those receiving corneal replacement for infectious keratitis and aniridia. Financial Disclosure(s) The authors have no proprietary or commercial interest in any of the materials discussed in this article.

BACKGROUND AND OBJECTIVE: Conjunctival nevi are benign lesions with wide variation in clinical and histopathological features. The differentiation between benign nevi and other pigmented lesions is essential. The aim of our study was to identify the distribution of the histopathologic types of conjunctival nevi among the Saudi population and to provide the basic knowledge needed for proper clinical diagnosis. PATIENTS AND METHODS: This retrospective study of surgically excised benign conjunctival nevi was conducted at a tertiary care eye hospital from 1995 to 2006. Clinical data was collected from medical records and the histopathologic features reviewed by a single pathologist. RESULTS: A total 105 conjunctival nevi were included from 104 consecutive patients (mean age, 26 years, 54 males and 50 females). The anatomical location was the bulbar conjunctiva in 83%, juxtalimbal in 12%, caruncle in 4% and palpebral in 1%. The lesion was removed for cosmetic reasons in 38% while 8% of the lesions were removed to rule out malignancy. The compound nevus was the commonest (72%) in all age groups, followed by subepithelial nevus (24%) and finally junctional nevus (3%). CONCLUSIONS: The distribution of the histopathologic types of this tumor in our population matches the pattern in other areas of the world with the compound nevus being the commonest lesion. However, fewer lesions among our patients are removed to rule out malignancy.

Over 2 decades of research, several design modifications, and improvements in post-operative management have made Boston keratoprosthesis (B-KPro) a viable option for patients with corneal blindness for whom traditional keratoplasty procedure has a very low probability of success. In this systematic review, we examined the indications, visual outcomes, complications and retention rate of the literature published in the past 10 years (2005–2014). While most of the studies report smaller datasets (typically

We describe a protocol for adequate repositioning of free laser in situ keratomileusis (LASIK) corneal flaps created by a Moria M2 microkeratome even in the absence of fiduciary marks. In an enucleated porcine globe, a free flap was created by initially placing a longitudinal incision at the proposed hinge site followed by activating the forward pass of the automated microkeratome. A protocol was devised based on placement of a positioning dot on the free flap before the flap is retrieved from the microkeratome head. Preplaced surgical landmarks were used as a guide to determine the correct alignment of the free flap. Adequate orientation of the free flap to the stromal bed was achieved in 9 porcine eyes using the positioning dot method. The technique is applicable to the Moria M2 microkeratome only and must be validated for other types of keratomes.

Purpose: To evaluate the visual outcomes, complications and retention of threadless type I Boston keratoprosthesis (KPro) in Saudi Arabia. Materials and Methods: Retrospective analysis of four eyes of four patients (one female and three males; age range: 48 to 72 years) who underwent Boston type I threadless KPro implantation between January and December 2009. Results: In the median follow-up of 11 months (range 6 to 14 months), visual outcomes were satisfactory. Preoperative diagnosis included two patients of post-trachoma dense vascularized corneal scarring, one patient of corneal alkali burn and one patient of repeated failed corneal grafts. All patients demonstrated significant improvement in vision; with pre-operative visual acuity of hand movements (HM), counting fingers and HM improved to best corrected visual acuity (BCVA) of 20/200, 20/60, 20/50 and 20/30 on their last follow-up visits respectively. None of the patients developed glaucoma as a result of the procedure. No retro-prosthetic membrane developed till the last follow-up visit. One of the four patients had a corneal melt (due to severe dryness associated with trachoma) 6 months after the KPro implantation and underwent a successful KPro revision. Despite the relatively poor prognosis expected in alkali burn eye, the patient attained the maximum BCVA (20/30) of the four eye series on the last follow-up visit at six months. Conclusion: In consistent with the earlier reports from other parts of the world, all the 4 eyes had a significant increase in vision after Boston type I KPro implantation. However, patients require close lifelong follow-up to manage any complications.

We are reporting a 34-year-old Arabic white female patient who presented with a white mass covering her left cornea following multiple ocular surgeries and healed corneal ulcer. The lesion obscured further view of the iris, pupil and lens. The patient underwent penetrating keratoplasty and the histopathologic study of the left corneal button showed epithelial hyperplasia, absent Bowman’s layer and subepithelial fibrovascular proliferation. The histopathologic appearance was suggestive of a corneal keloid which was supported by further ultrastructural study. The corneal graft remained clear 6 months after surgery and the patient was satisfied with the visual outcome. Penetrating keratoplasty may be an effective surgical option for corneal keloids in young adult patients.

Abstract Achieving successful zonal isolation is critical to install smart completion tools. Currently, cementing and mechanical packers are the only conventional methods used in Saudi fields to provide zonal isolation. However, these techniques are difficult to operate and result in reduced inner casing string diameter. Another method to provide zonal isolation for smart completion tools and to complete them in single stage is to use a rubber elastomer bonded onto a base pipe. The rubber swells in oil and provides a seal between the base pipe and the open hole. This paper will outline the step-by-step qualification testing that was carried out by Saudi Aramco facilities in an attempt to improve zonal isolation for smart completions. In this study, we present lab evaluation of elastomers at 190°F using six different oil samples. The evaluation involved studying the effect of oil viscosity and API gravity. Also, the study investigated the effect of acids on the swelled elastomers. To the best of the authors' knowledge no previous work was done to investigate the impact of these factors on the swelling mechanisms. The elastomer bonded in pipes was tested in autoclaves. The pressure drop across the pipes was measured as a function of time. The effects of other factors were investigated using elastomer samples and fluid characterization. The oil swelling elastomers withstood pressure up to 5,000 psi at 190°F after placing the elastomers in some crude oils. In addition, the elastomers swelled rapidly in some oils and slowly in others. Introduction Swelling packers can be used for multiple-zone open-hole completions. These packers will swell when in contact with wellbore fluids (oil or water). Open-hole completions become attractive because they require fewer trips and no cementing near-wellbore damage that can limit production. Swelling packers can be used for any of the following reasons:1 Horizontal sections where cementing is difficult, lateral zones with compartmental isolation, and large permeability variation zones. There are no operational difficulties in running the swelling packers. There are two types of packers; water swelling and oil-swelling. Contaminations in the wellbore fluids can affect the swelling of the packers. Oil swelling elastomer will swell faster in lighter oils compared to heavier ones. In field applications where acid stimulation is required, the swelling packers will be exposed to acids. Common acid used in carbonate formations is HCl at various concentrations. Higher concentrations of HCl acid will affect the swelled packers, but not the weak ones.1 The swelling packers depend on thermodynamic absorption process. All liquids have solubility parameter which is the energy required to vaporize them. The packers have two components which are polymers and flexible materials. When the polymer is immersed into a liquid with similar solubility parameter, a strong affinity between the polymer and liquid will result. These affinities will cause swelling of the polymer and as a result the flexible material will expand. The result of this is that the packer will swell in some cases to several 100% by volume. The swelling will continue until equilibrium is reached. The time to reach equilibrium will be reduced with increase in temperature. When swelling reaches equilibrium, the mechanical properties and volume remain constant. If further expansion after equilibrium is reached it will be due to thermal chain degradation in the polymer. When expansion is limited by the wall of the hole, the packer will not reach equilibrium and will continue to swell until it does.2

Purpose: To analyze the visual results of Descemet stripping automated endothelial keratoplasty (DSAEK) in the first consecutive 10 cases. Materials and Methods: Retrospective, non-randomized, non-comparative interventional case series. Ten eyes of 10 patients with endothelial dysfunctions of different etiology, scheduled for DSEAK, were included in this study. Indications, operative problems, and postoperative complications were noted. Best-corrected visual acuity, refractive and keratometric astigmatism, and central corneal thickness were analyzed for each patient after a minimum follow-up of 10 months. Results: In a median follow-up of 12 months (range 10-16 months), visual outcomes were satisfactory. Preoperative diagnosis included five eyes of psuedophakic bullous keratopathy and two eyes of repeated failed corneal grafts and one bullous keratopathy secondary to anterior chamber phakic IOL implantation. Two eyes with Fuchs dystrophy and cataract had combined DSAEK and phacoemulsification and IOL implantation. One patient had known glaucomatous optic nerve precluding vision better than 20/150. Of the remaining nine patients, four eyes had BSCVA of 20/40 or better by postoperative 6 months (3 by 3 months). The average pachymetry was 646.9 μm. One patient had total graft dislocation and one needed trabeculectomy. None of the patients developed graft rejection or graft failure. None of patients needed to convert to penetrating keratoplasty. Conclusion: DSAEK is safe and effective procedure in patients with endothelial dysfunctions with encouraging surgical and visual outcomes.

Objective To study the safety and efficacy of topical bevacizumab in the treatment of corneal neovascularization (NV). Design In a prospective, open-label, noncomparative study, 10 eyes from 10 patients with stable corneal NV were treated with topical bevacizumab, 1.0%, for 3 weeks and followed up for up to 24 weeks. Main Outcome Measures The primary safety variables were the occurrence of ocular and systemic adverse events throughout the course of the study. The primary efficacy variables were neovascular area, the area of the corneal vessels themselves; vessel caliber, the mean diameter of the corneal vessels; and invasion area, the fraction of the total corneal area covered by the vessels. Results From baseline visit to the last follow-up visit, mean reductions were 47.1% (standard deviation [SD], 36.7%) for neovascular area, 54.1% (SD, 28.1%) for vessel caliber, and 12.2% (SD, 42.0%) for invasion area. The decreases in neovascular area and vessel caliber were statistically significant ( P = .001 and P P = .19). Visual acuity and central corneal thickness showed no significant changes. Topical bevacizumab was well tolerated with no adverse events. Conclusions Short-term topical bevacizumab therapy reduces the severity of corneal NV without local or systemic adverse effects. Application to Clinical Practice Topical bevacizumab provides an alternative therapy in the treatment of stable corneal NV. Trial Registration clinicaltrials.gov Identifier:NCT00559936