Dietary Attitude of Adults with Type 2 Diabetes Mellitus in the Kingdom of Saudi Arabia:A Cross-sectional study.

Background and Objectives: There is a paucity of literature on the dietary attitude (DA) of patients with type 2 diabetes in the Kingdom of Saudi Arabia (KSA). Although the prevalence of diabetes mellitus (DM) is high in Gulf countries, there remains a lack of understanding of the importance of dietary behavior in diabetes management among patients. Understanding the behavior of patients with diabetes towards the disease requires knowledge of their DA. Therefore, this study aimed to assess and evaluate the DA of type 2 diabetes patients, and it is the first of its kind in the KSA. Material and Methods: An analytical cross-sectional study was conducted among 350 patients with type 2 diabetes. A self-administered DA questionnaire was used to collect the data. Psychometric properties of the questionnaire were assessed by face validity, content validity, exploratory factor analysis, and internal consistency reliability. The data were collected using a systematic random sampling technique. Results: The overall DA of the patients was inappropriate (p = 0.014). Patients had an inappropriate DA towards food selection (p = 0.003), healthy choices(p = 0.005), food restraint (p < 0.001), health impact (p < 0.001), and food categorization (p = 0.033). A poor DA was also observed in relation to the consumption of red meat(p < 0.001), rice (p < 0.001), soup and sauces (p = 0.040), dairy products (p = 0.015), and junk food(p < 0.001). Conclusions: It is highly recommended that patients with diabetes receive counseling with an empowerment approach, as this can bring about changes in their dietary behavior, which is deeply rooted in their daily routine. Healthcare providers should also be well-informed about patients' attitudes and beliefs towards diabetes to design tailored educational and salutary programs for this specific community. Diabetes self-management educational programs should also be provided on a regular basis with a special emphasis on diet and its related components.

Endoscopic cyclophotocoagulation for glaucoma compared to alternative procedures -A Systematic review.

INTRODUCTION: Despite many recent developments, preference in the choice of surgical treatment of uncontrolled intraocular pressure (IOP) remains a challenge. OBJECTIVE: This study compares the clinical efficacy and safety of endoscopic cyclophotocoagulation (ECP) to alternative surgical procedures, for all types of glaucoma. METHODOLOGY: The methodology adheres to the preferred reporting items for systematic reviews and meta-analyses guidelines for systematic review reporting. Studies reporting ECP and alternative surgeries in treating refractory glaucoma, neovascular glaucoma, aphakic glaucoma, filtering surgical failure-induced glaucoma, congenital or juvenile glaucoma, and secondary glaucoma such as uveitis glaucoma, traumatic glaucoma, secondary glaucoma postcorneal transplantation, etc. were included. The efficacy was evaluated from the number of IOP-lowering drugs, and mean change in pre- and post-IOP were the outcomes assessed in ECP and non-ECP groups in this review. Evaluations of the postoperative complications revealed the safety assessment of the procedure. RESULTS: In total, 11 relevant studies were selected in this study with a total of 5418 eyes, including 763 eyes in the ECP group and 4655 in the non-ECP group. This review observed that both ECP and non-ECP procedures had been successful in reducing postoperative IOP. CONCLUSION: It can be deduced from this review, that all types of glaucoma can be treated efficiently with significantly higher success rates with ECP and ECP demonstrates lowest postoperative complications when compared to non ECP procedures. This review provides updated scientific evidence which caters to support clinical decisions for surgical treatment of glaucoma.

Current State of Knowledge in Ocular Blood Flow in Glaucoma: A Narrative Review.

Glaucoma is a multifactorial disease that is dependent on Intra Ocular Pressure (IOP) and associated with risk factors related to reduced ocular blood flow (OBF). In clinical practice, it is instrumental to update and review the considerable evidence of the current imaging technologies utilized in the investigation of OBF involved in both the onset and progression of glaucoma. Bibliographic databases, including PubMed and Google Scholar, were searched for articles on OBF techniques published between 2018 and 2023 using keywords such as "ocular blood flow", "glaucoma", "invasive ocular blood flow measurement", and "non-invasive ocular blood flow measurement". All types of methodologies were considered, except for editorials, letters to the editor, and animal studies. This review provides comprehensive information on the recent state-of-the-art imaging innovations used to monitor and measure the ocular blood flow in glaucoma.

Transepithelial Photorefractive Keratectomy Compared to Conventional Photorefractive Keratectomy: A Meta-Analysis.

This meta-analysis review compares the primary and secondary outcomes of transepithelial photorefractive keratectomy (TPRK) to the conventional photorefractive keratectomy (PRK), in terms of efficacy, predictability, safety, and patient perspectives. A total of 1711 eyes with PRK (811 eyes) and TPRK (900 eyes) from 12 studies were included through bibliographic searches. The main outcomes were efficacy, predictability, and safety parameters, and the secondary outcomes included visual and patient-reported parameters. The effect measures were weighted mean differences with 95% confidence intervals (CI) which were derived from the random-effects model of the meta-analysis to account for possible heterogeneity. TPRK procedure presents a comparable status in the main outcome and a very dominant significance in all the secondary outcomes in this meta-analysis. This study updates the evidence of the accuracy of TPRK procedure for surgical correction of all refractive errors and was deemed safer with less surgical time required and an early healing time.

Comparison of the efficacy of lotrafilcon B and comfilcon A silicone hydrogel bandage contact lenses after transepithelial photorefractive keratectomy.

Background: At completion of transepithelial photorefractive keratectomy (t-PRK) surgery, the eye is usually fitted with a bandage contact lens to reduce discomfort and promote epithelial healing. This study aimed to compare the outcomes of eyes fitted with lotrafilcon B versus comfilcon A, silicone hydrogel bandage contact lenses after t-PRK for the correction of low to moderate myopia, with or without astigmatism. Methods: In this comparative, prospective study, patients with myopia < -6 D with or without astigmatism (< 1.75 D), who underwent t-PRK between January and June 2018, were randomly allocated to the lotrafilcon B and comfilcon A groups. Preoperative characteristics, including age, sex, eye treated, uncorrected visual acuity (UCVA), best-corrected visual acuity, mesopic pupil size, central corneal thickness, and refractive error were recorded. Postoperatively, pain score, UCVA, and corneal epithelial defect size on days 1, 4, and 7 were compared between the two groups. Results: Twenty-nine eyes were included in each group. Demographic characteristics and preoperative measurements were similar between the two groups. UCVA was significantly improved on day 7 as compared to day 1 in the comfilcon A group (P = 0.03), but remained the same in the lotrafilcon B group (P = 0.70) as on day 1 postoperatively. There was no significant difference in UCVA between the two groups at any follow-up visits (all P > 0.05). The pain score on the first postoperative day was significantly higher in the lotrafilcon B-fitted eyes than in the comfilcon A group (P < 0.001), but was significantly reduced in both groups compared to day 1 (both P < 0.001). The epithelial defect in the comfilcon A group was significantly greater than in the lotrafilcon B group (P < 0.001) at day 1 postoperatively, with significant improvement in both groups (both P < 0.001). Conclusions: Healing responses were better with lotrafilcon B than with comfilcon A bandage contact lenses. The patients had a greater mean pain score with lotrafilcon B than with comfilcon A lenses on the first postoperative day, yet the final outcome was comparable between the two groups. We did not encounter any postoperative complications related to contact lens wear.

Use of online resources by undergraduate medical students at College of Medicine, Majmaah University, Kingdom of Saudi Arabia.

The current pandemic has revolutionized medical education with a rapid shift to online teaching and learning strategies. The students have coped by turning to the online resources to keep pace with the change. To determine the type and practice of online resources used by undergraduate medical students and compare the use of online resources with gender and GPA. This was a cross-sectional study in which an online self-administered questionnaire was used to evaluate the type and practices of the online resources used by the medical students during the Covid-19 pandemic. Complete enumeration sampling method was used to collect the data from 180 medical students studying at College of Medicine, Majmaah University, Saudi Arabia. One hundred and thirty students (72.2%) were unaware of the free online resources offered by the University. Most students (58.3%, n = 105) consulted peers for online references. Male students preferred PowerPoint presentations and consulting online resources for studying as compared to the females, whereas females preferred to study textbooks predominantly as compared to males (p = 0.005). Male students significantly shifted to the online resources during the COVID-19 pandemic as compared to females (p = 0.028). Students with the highest GPA scores shifted to online educational resources during pandemic. A significant proportion of the undergraduate medical students at College of Medicine, Majmaah University used online educational resources for learning. We recommend that the college administration for deliberation with the medical educationalists for necessary curricular amendments and taking necessary steps to make the college Academic supervision and mentorship program more proactive to meet the challenges of students' use of online educational resources.

Effect of sleeping in a head-up position on intraocular pressure in patients with glaucoma.

PURPOSE: To determine whether a 30-degree head-up sleeping position decreases nocturnal intraocular pressure (IOP) compared with lying flat in patients with glaucoma. DESIGN: Prospective, nonrandomized comparative case series. PARTICIPANTS: Seventeen eyes of 17 patients with glaucoma with controlled IOP and new disc hemorrhage. METHODS: Patients with a new disc hemorrhage despite well-controlled IOP were evaluated in a sleep laboratory on 2 separate nights, the first night lying flat and the second night in a 30-degree head-up position. Intraocular pressure and blood pressure (BP) were measured every 2 hours from 6 PM to 8 AM. For the 6 PM, 8 PM, 10 PM, and 8 AM measurements (awake period) the subjects were sitting for both nights. For the midnight, 2 AM, 4 AM, and 6 AM measurements (sleep period), the subjects were supine for the first night and 30 degrees head up for the second night. MAIN OUTCOME MEASURE: Difference in IOP during the sleep period (midnight to 6 AM) between lying flat and 30-degree head-up positions. RESULTS: Seventeen eyes of 17 patients were included. There were no significant differences (P=0.68) between the 2 study visits in IOP during the awake period (6 PM, 8 PM, 10 PM, and 8 AM) when patients were sitting upright. During the sleep period (midnight to 6 AM) the mean IOP was 3.2 mmHg lower in the 30-degree head-up position compared with the flat position (P=0.03; 95% confidence interval, 0.25-6.1 mmHg). Sixteen of 17 patients (94.1%) had lower IOP in the 30-degree head-up position. The reduction in IOP in the 30-degree head-up position was 20% or more in 35% of patients (6/17). There were no differences in BP or ocular perfusion pressure between the 2 positions. CONCLUSIONS: The 30-degree head-up sleeping position lowers IOP compared with the flat position. Although this effect varies between individual patients, mean IOP was 20% lower in one third of patients in this series. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.

An Adoptive Threshold-Based Multi-Level Deep Convolutional Neural Network for Glaucoma Eye Disease Detection and Classification.

Glaucoma, an eye disease, occurs due to Retinal damages and it is an ordinary cause of blindness. Most of the available examining procedures are too long and require manual instructions to use them. In this work, we proposed a multi-level deep convolutional neural network (ML-DCNN) architecture on retinal fundus images to diagnose glaucoma. We collected a retinal fundus images database from the local hospital. The fundus images are pre-processed by an adaptive histogram equalizer to reduce the noise of images. The ML-DCNN architecture is used for features extraction and classification into two phases, one for glaucoma detection known as detection-net and the second one is classification-net used for classification of affected retinal glaucoma images into three different categories: Advanced, Moderate and Early. The proposed model is tested on 1338 retinal glaucoma images and performance is measured in the form of different statistical terms known as sensitivity (SE), specificity (SP), accuracy (ACC), and precision (PRE). On average, SE of 97.04%, SP of 98.99%, ACC of 99.39%, and PRC of 98.2% are achieved. The obtained outcomes are comparable to the state-of-the-art systems and achieved competitive results to solve the glaucoma eye disease problems for complex glaucoma eye disease cases.

Dietary Knowledge among Adults with Type 2 Diabetes-Kingdom of Saudi Arabia.

Dietary management is considered as a major step in assessing a patient's knowledge related to nutritional aspects, treatment, and complications of diabetes. Diabetes patients frequently face difficulty in identifying the recommended diet, including its quality and quantity. In the Kingdom of Saudi Arabia (KSA), sedentary lifestyle, along with food choices and portion sizes, have increased considerably and this has resulted in the soaring risk of diabetes. In addition, there is paucity of literature focusing on the Dietary Knowledge (DK) of type 2 diabetics in KSA. The study aimed to assess and evaluate the DK of type 2 diabetics. An analytical cross-sectional study was conducted among 350 type 2 diabetics using a valid and reliable self-prepared questionnaire comprising of 21 questions. Results showed that type 2 diabetics had an overall poor DK (28.57%). Sub-group analysis further revealed that diabetes patients had poor knowledge related to the consumption of carbohydrates and food choices, whereas they had good knowledge related to lipids and fats, proteins and food types. The role of diet in controlling of diabetes is considered imperative, but still, diabetes patients are unaware how they should approach this issue. The patient empowerment approach can be used to counsel patients with a poor DK. Primary care physicians and dietitians should work together and carry out individualized, tailored and patient-centered dietary education sessions.

Macular ganglion cell complex parameters by optical coherence tomography in cases of multiple sclerosis without optic neuritis compared to healthy eyes.

Purpose: To compare different macular thickness parameters and peripapillary retinal nerve fiber layer (RNFL) thickness between recently diagnosed cases of multiple sclerosis (MS) without optic neuropathy (ON) and healthy individuals. Methods: This cross-sectional study was performed between June 2014 and June 2015. All subjects underwent ocular and retinal examination. Spectral domain optical coherence tomography (SD-OCT) was used to measure the thickness of different layers of the retina at macular and peripapillary regions and at different quadrants. Between groups comparison was performed with P < 0.05 indicating statistical significance. Results: There were 32 eyes in the MS group and 74 eyes in the control group. The MS group was significantly younger than the control group (P < 0.001). The mean ganglion cell complex (GCL++) thickness in superior macular area was 64.1 ± 8.9 µ in the MS group and 71.1 ± 5.9 µ in the control group. The thickness of the RNFL did not statistically differ in each of the quadrants between groups. Despite controlling for age, the macular thickness parameters were significantly thinner in eyes with MS compared to healthy eyes (P < 0.01). Conclusion: The macular ganglion cell complex (mGCC) parameters were significantly reduced in recently diagnosed cases of MS as compared to healthy individuals.

Public Awareness regarding the Differences between Ophthalmologists and Optometrists among Saudi Adults Living in Riyadh: A Quantitative Study.

Awareness of the patients to the differences between ophthalmologists and optometrists has been recognized as an important factor influencing patient utilization of available eye care services. This study aimed at assessing the public's knowledge of the differences between ophthalmologists and optometrists among the residents of Riyadh, Saudi Arabia. An online questionnaire was administered to adults in Riyadh, Saudi Arabia, from January to February in 2018. The number of the respondents was 1579. Results show that 50% (n=789) of the participants had fair knowledge of the differences between ophthalmologists and optometrists, while 32% (n=505) had poor knowledge. After multivariate logistic regression analysis, there was a significant association between satisfactory knowledge and visiting an optometrist (odds ratio (OR): 0.75, 95% CI: 0.57-0.98), age older than 26 (OR: 1.73, 95% CI: 1.17-1.19), higher level of education (OR: 1.92, 95% CI: 1.54-2.4), and wearing spectacles (OR: 0.57, 95% CI: 0.45-0.73). Given the low level of public knowledge regarding the differences in the duties between ophthalmologist and optometrists among a Saudi population, there is great potential for general population education through awareness campaign and social media regarding eye care provider's duties and practices.

Risk of Breaking Haptic of Trifocal IOL and Its Management.

Fracture of an intraocular lens (IOL) haptic is a rare complication of cataract surgery. A broken haptic can cause serious damage in the anterior and posterior segments. To the best of our knowledge, a broken haptic in a high-quality, commercially available trifocal IOL has not been documented in the literature. Prompt and proactive action at 1 day postoperatively aided in addressing the complication and restoring the vision. We suggest that the ophthalmologist performed a thorough evaluation on the 1st postoperative day and take immediate action after a discussion with the patient and relatives.

Macular Ganglion Cell-Inner Plexiform Layer and Retinal Nerve Fiber Layer Thickness in Eyes With Primary Open-Angle Glaucoma Compared With Healthy Saudi Eyes: A Cross-Sectional Study.

PURPOSE: We compared the thickness of the ganglion cell-inner plexiform layer at the macula (mGCIPL) and the thickness of the retinal nerve fiber layer (RNFL) in different regions of the retina in eyes with primary open-angle glaucoma (POAG group) and normal eyes (control group). DESIGN: This was a cross-sectional study performed in 2014. METHODS: Spectral domain optical coherence tomography (SD-OCT) was used to measure mGCIPL and RNFL thickness. Age-adjusted means and standard deviation were calculated. Age, sex, refractive status, corneal thickness, and stage/severity of glaucoma (defined by vertical cup-to-disc ratio and visual field changes) were associated to outcomes. Statistical significance was indicated by P < 0.05. RESULTS: There were 50 eyes in the POAG group and 52 eyes in the control group. The difference in age between patients in both groups was statistically significant (P < 0.001). The age-adjusted measurements were thinner for POAG with a mean difference (DF) of 11.1 µm for mGCIPL and 8 µm for mRNFL. The mGCIPL to mRFNL ratio was 2.1 in the POAG group and 1.9 in the control group (degrees of freedom = 0.2, P = 0.001). The mGCIPL and RNFL thickness decreased as the severity of glaucoma increased. The mGCIPL to mRNFL ratio was a predictor of the severity of field defects in POAG (AUROC = 0.66, P = 0.0002). Age and myopia were confounders to the association of OCT findings and the visual field changes in POAG (P = 0.07). CONCLUSIONS: There was generalized thinning of retinal layers in eyes of nondiabetic Arab patients with POAG. OCT parameters can be important for detecting and monitoring glaucoma cases.

Lack of Correlation Between Diabetic Macular Edema and Thickness of the Peripapillary Retinal Nerve Fibre Layer.

INTRODUCTION: We compared the thickness of the peripapillary retinal nerve fiber layer (RNFL) in patients with diabetic macular edema (DME) and/against the thickness in the normal population. METHODS: This cross-sectional study compared the RNFL thickness in patients with DME (DME group) using optical coherence tomography (OCT) to a comparable group of healthy (nondiabetic) patients (control group). Measurements were performed in different/the four peripapillary quadrants and in the macula region for the fovea, parafoveal, and perifoveal areas. The mean RNFL thickness was compared between both groups. RESULTS: There were fifty eyes of fifty nonglaucomatous diabetic patients with DME (29 with nonproliferative diabetic retinopathy [PDR] and 21 with PDR), and fifty eyes in the control group. The macular regions were significantly thicker in the DME group compared to the control group. The central foveal thickness was 149 µ thicker in eyes with DME compared to the control group (P < 0.001). The difference in total RNFL thickness between groups was not significant (4.4 µ [95% confidence interval: -3.1 to +12]). The between-group differences in peripapillary RNFL thickness by age group, glycemic control, history of intravitreal treatments, and refractive errors were not statistically significant (P > 0.05, all comparisons). CONCLUSION: Peripapillary RNFL thickness measurements were not significantly influenced by DME. Hence, OCT parameters could be used to monitor/early detect glaucomatous eyes even in the presence of DME.

Argon Laser Photoablation for Treating Benign Pigmented Conjunctival Nevi.

PURPOSE: To evaluate the outcomes of argon laser photoablation of benign conjunctival pigmented nevi with different clinical presentations. PATIENTS AND METHODS: This interventional case series was conducted between July 2014 and January 2015. Patients presenting with benign conjunctival nevi were included. Data were collected on the clinical features at presentation, argon laser photoablation, and follow-up at 8 and 24 weeks. Postoperative photography allowed recording of the success of each case and the overall success rate. Complete removal of conjunctival pigments was considered an absolute success. Partial pigmentation requiring repeat laser treatment was considered a qualified success. RESULTS: There were 14 eyes (four right eyes and ten left eyes) with benign pigmented conjunctival nevi. There were three males and eight females in the study sample. The median age was 36 (25% percentile: 26 years). Three patients had bilateral lesions. The nevi were located temporally in nine eyes, nasally in three eyes, and on the inferior bulbar conjunctiva in two eyes. The mean horizontal and vertical diameters of nevi were 5 ± 2 mm and 4 ± 2.7 mm, respectively. The mean follow-up period was 5 months. Following laser treatment, no eyes had subconjunctival hemorrhage, infection, scarring, neovascularization, recurrence, or corneal damage. The absolute success rate of laser ablation was 79%. Three eyes with elevated nevi had one to three sessions of laser ablation resulting in a qualified success rate of 100%. CONCLUSIONS: Argon laser ablation was a safe and effective treatment for the treatment of selective benign pigmented conjunctival nevi in Arab patients.

Outcomes of Ahmed valve surgery for refractory glaucoma in Dhahran, Saudi Arabia.

AIM: To evaluate the outcomes of Ahmed glaucoma valve (AGV) implantation surgery for refractory glaucoma. METHODS: This one-armed historical cohort study was conducted in 2011. Refractory glaucoma was defined as eyes with an intraocular pressure (IOP) greater than 21 mm Hg with maximally tolerated glaucoma medications, failed surgeries, or both. For all eyes with refractory glaucoma that underwent AGV implantation, data were collected on IOP, the best corrected visual acuity (BCVA) and glaucoma medications preoperatively and 4, 6, 12, 24 and 56wk postoperatively. Logarithm values of IOP were calculated and compared. RESULTS: The study group was comprised of 30 patients (30 eyes, 16 males and 14 females) with refractory glaucoma. Mean preoperative IOP was 39.3±13.8 mm Hg. Postoperative mean IOP was 15.7±7.1 mm Hg, 19.6±12.8 mm Hg and 13.9±14.2 mm Hg at 12, 24 and 56wk respectively. BCVA was ≥ 6/60 in 11 eyes preoperatively, and five eyes had BCVA≥6/60 at 56wk postoperatively. Preoperatively, more than four medications were used to treat glaucoma in 21 eyes. At 12wk postoperatively, no medications were required to control IOP in 20 eyes. At 56wk postoperatively, at least one medication was required to control IOP in 10 eyes. Over the entire follow up period, four eyes were treated with yttrium aluminium garnet (YAG) laser and 14 eyes required a second surgery. The AGV was removed in four eyes. CONCLUSION: AGV implantation reduced IOP and the number of medications required to control refractory glaucoma. However, there was a higher risk of decreased vision. Long-term follow up and prompt intervention are recommended.

Cataract Surgery Audit at a Private Hospital in Saudi Arabia.

BACKGROUND: To assess the visual outcomes following cataract surgeries at a Private Eye Hospital in Riyadh, Saudi Arabia. METHODS: This was a cohort study of cataract surgeries performed from January to June 2014. Preoperative data were collected on patient demographics presenting and best corrected distance visual acuity (BCVA) and ocular comorbidity. Data were also collected on the type of surgery, type of intraocular lens (IOLs) implanted, and complications. BCVA and refractive status at 6-8 weeks postoperatively were noted. The predictors of vision ≥ 6/18 were identified. RESULTS: Four hundred eyes of 400 patients underwent cataract surgery. There were 235 (59%) males. Presenting preoperative vision was < 6/60 in 52 (13%) eyes. There were 395 (99%) eyes that underwent IOL implantation following phacoemulsification and 4 eyes received a sulcus fixated IOL. A single piece aspheric IOL was implanted in 358 (90%) eyes and a toric IOL was implanted in 31 (8%) eyes. Postoperative BCVA was classified as a "good outcome" (≥ 6/18) in 320 (80%) and a "poor outcome" (< 6/60) in 24 (6%) eyes. Young age (adjusted odds ratio (OR) = 0.97, P = 0.01), male (adjusted OR = 2.4, P = 0.002), and ocular co-morbidities (adjusted OR = 0.2, P < 0.001) were predictors of vision ≥ 6/18. Complications included a dropped nucleus and a posterior capsular tear in 2 eyes each. Two hundred and fifty-two (63%) eyes were emmetropic or intentionally myopic for distance. Astigmatism < 2 D was present in 264 (66%) eyes and astigmatism > 2 D was present in 33 (8%) eyes. CONCLUSION: The recent trend of intentional overcorrection in one eye following modern cataract surgery in order to provide some functional near vision indicates that benchmark for success in getting "good visual outcomes" postoperatively (vision of ≥ 6/18) may need to be revised.

Conjunctival complications related to Ahmed glaucoma valve insertion.

PURPOSE: Conjunctival complications may occur after glaucoma drainage device surgery. We analyzed the frequency, risk factors, management and outcomes of Ahmed glaucoma valve (AGV)-related conjunctival complications. METHODS: Retrospective review of postoperative conjunctival complications in patients undergoing AGV insertion. Only subjects with ≥1-year follow-up were included. RESULTS: The charts of 158 subjects with a median age of 64±16.2 years were reviewed. Median follow-up was 43.5 months (range, 12 to 103 mo). Fifty-three (33.5%) wound dehiscences and 14 (8.9%) device exposures were diagnosed 31.6±35.7 and 996±735 days after procedure, respectively (P<0.001). Ninety-one subjects (57.6%) had no conjunctival complications. This uncomplicated group used 3.3 (±1.1) [95% confidence interval (CI): 3.07, 3.51] hypotensive medications before surgery as compared with 3.8 (±1.1) (95% CI: 3.48, 4.10) and 3.9 (±0.9) (95% CI: 3.36, 4.36) for dehiscence and exposure groups, respectively (P=0.01). The inferonasal quadrant was associated with the highest rate of dehiscences (4/7, 57.1%) (95% CI: 18.4, 90.1), followed by the inferotemporal quadrant (30/65, 46.2%) (95% CI: 33.1, 58.2), the superotemporal (15/61, 24.6%) (95% CI: 12.9, 33.8), and the superonasal (4/25, 16%) (95% CI: 10.9-52.0; P<0.0073). There were no differences in dehiscence and exposure rates between limbal versus fornix-based approaches (P=0.54; 95% CI: 24.8-44.9, 24.4-45.7, 5.9-19.6, 3-45.1, respectively). Forty-eight (90.6%) dehiscent wounds resolved with conservative management and 5 were resutured, whereas all exposed devices were managed surgically. CONCLUSIONS: Conjunctival dehiscence is usually a benign, common complication after AGV insertion. It does not need repair as long as the tube is well covered. AGV tube or plate exposures are less common, occur later and were promptly repaired as per current practice. Important factors predisposing to these problems include a greater number of preoperative hypotensive medications and the implantation quadrant.

Effect of beclomethasone nasal spray on intraocular pressure in ocular hypertension or controlled glaucoma.

PURPOSE: To evaluate the effect of 6 weeks administration of beclomethasone nasal spray on intraocular pressure (IOP) in patients with ocular hypertension or controlled primary open-angle glaucoma. PATIENTS AND METHODS: Randomized double-masked controlled trial. Patients were randomized to twice daily beclomethasone versus placebo saline nasal spray. There were a total of 4 study visits: baseline and weeks 2, 4, 6 after starting the spray. Each study visit was at the same time within a 1-hour time window. Primary outcome measure was IOP. Secondary measures included visual acuity, anterior segment changes, patient reported side effects, and compliance. Study endpoint was 6 weeks from the start of treatment or an IOP increase of >20% from baseline. A sample size calculation suggested that 8 patients in each arm would be sufficient to detect a difference of 3.2 mm Hg with a power of 80%. RESULTS: Nineteen consecutive consenting patients completed the study-9 in the steroid arm and 10 in the placebo arm. There were no statistically significant differences between groups in baseline characteristics, IOP at each study visit, or change in IOP from baseline at any time point. At 6 weeks, the change in mean IOP from baseline was +0.50±1.52 versus +0.70±1.44 mm Hg in the steroid and saline nasal spray groups, respectively (P=0.77). CONCLUSIONS: Patients with ocular hypertension and primary open-angle glaucoma showed no evidence of IOP elevation after 6 weeks use of beclomethasone nasal spray.

Evaluation of investigator bias in industry-funded clinical trials of latanoprost.

OBJECTIVE: To determine whether sponsorship of prostaglandin analogue (PGA) clinical trials results in investigator bias in outcomes when studying intraocular pressure (IOP). DESIGN: Retrospective, observational cohort study. METHODS: A PubMed search was performed for latanoprost or Xalatan, bimatoprost or Lumigan, and travoprost or Travatan, with limits to humans, clinical trials, and English language. Inclusion criteria included randomized controlled trials, open-angle glaucoma, monotherapy with a PGA, baseline IOP ≥ 21 mm Hg, washout period, and minimum 1-month follow-up. Each article was reviewed by 2 independent reviewers. The results of IOP for each PGA were categorized as being sponsored by the parent company (the company manufacturing the PGA); by the competing company (the company manufacturing competing glaucoma therapy); or by a nonindustry source. The mean IOP and changes in IOP from baseline were compared among the 3 categories of sponsorship. RESULTS: Only studies involving latanoprost were analyzed because of the low number of studies meeting the inclusion criteria for bimatoprost and travoprost. We found 29 and 13 studies that provided 1- and 3-month data, respectively, for analysis. The mean baseline IOPs in the 3 groups (parent company, competing company, nonindustry) were not significantly different (p = 0.47). The mean IOP at 1 (p = 0.72) and 3 months (p = 0.59) and the change in IOP from baseline (p = 0.83 and 0.90, respectively) were not significantly different in the 3 groups. A random-effects metaregression controlling for the covariates of blinding, naïveté to PGAs, and baseline IOP < 24 mm Hg or ≥ 24 mm Hg did not change the findings. CONCLUSION: There was no evidence of investigator bias in determining outcomes for IOP in these clinical trials of latanoprost.