Dysfunctional tear syndrome: dry eye disease and associated tear film disorders - new strategies for diagnosis and treatment.

Dysfunctional tear syndrome (DTS) is a common and complex condition affecting the ocular surface. The health and normal functioning of the ocular surface is dependent on a stable and sufficient tear film. Clinician awareness of conditions affecting the ocular surface has increased in recent years because of expanded research and the publication of diagnosis and treatment guidelines pertaining to disorders resulting in DTS, including the Delphi panel treatment recommendations for DTS (2006), the International Dry Eye Workshop (DEWS) (2007), the Meibomian Gland Dysfunction (MGD) Workshop (2011), and the updated Preferred Practice Pattern guidelines from the American Academy of Ophthalmology pertaining to dry eye and blepharitis (2013). Since the publication of the existing guidelines, new diagnostic techniques and treatment options that provide an opportunity for better management of patients have become available. Clinicians are now able to access a wealth of information that can help them obtain a differential diagnosis and treatment approach for patients presenting with DTS. This review provides a practical and directed approach to the diagnosis and treatment of patients with DTS, emphasizing treatment that is tailored to the specific disease subtype as well as the severity of the condition.

Outcome of astigmatism correction using femtosecond laser combined with cataract surgery: penetrating vs intrastromal incisions.

PURPOSE: To compare the effectiveness of penetrating vs intrastromal femtosecond laser corneal relaxing incisions (CRIs) in reducing corneal astigmatism during cataract surgery. SETTINGS: Baylor College of Medicine and Mercy Clinic Eye Specialists. DESIGN: Prospective randomized study. METHODS: 248 eyes from 248 patients were included. Patients were randomly assigned to undergo paired penetrating (8 mm optical zone [OZ] at 1 center and 9 mm OZ at the other) or intrastromal CRIs (8 mm OZ at both centers). The lengths of the CRIs were based on published nomograms but modified to take into account posterior corneal astigmatism. Vector analysis was performed, and net corneal changes along the CRI meridian were calculated. Multiple regression analysis was performed to assess factors contributing to net corneal changes. RESULTS: Preoperatively, 9% to 18% of eyes had corneal astigmatism of ≤0.5 diopters (D), and 76% to 93% of eyes had postoperative refractive astigmatism of ≤0.5 D ( P < .05). Both penetrating and intrastromal CRIs produced significant mean net corneal changes along the CRI meridian (-0.49 to -1.21 D), and 71% to 84% of eyes had postoperative astigmatism vector prediction errors of ≤0.50 D. The 8 mm penetrating CRIs induced greater net corneal changes but more eyes with overcorrection than did the intrastromal and 9 mm penetrating CRIs (all P < .05). Greater net corneal changes occurred with longer CRI length, higher preoperative corneal astigmatism magnitude, and preoperative against-the-rule corneal astigmatism. Nomograms based on anterior and total corneal astigmatism are proposed. CONCLUSIONS: Both penetrating and intrastromal CRIs were effective in reducing corneal astigmatism during cataract surgery.

Topical bromfenac 0.09% vs. ketorolac 0.4% for the control of pain, photophobia, and discomfort following PRK.

PURPOSE: To compare the efficacy of two topical nonsteroidal anti-inflammatory drugs with regards to the control of pain, burning, photophobia, foreign body sensation, and epithelial healing rates in patients who underwent photorefractive keratectomy (PRK). METHODS: Two hundred twelve eyes were randomized to receive topical postoperative ketorolac 0.4% four times daily (Acular LS, Allergan) or bromfenac 0.09% twice daily (Xibrom, ISTA Pharmaceuticals) in an open label trial. Patients having both eyes treated received ketorolac in one eye and bromfenac in the other. The epithelium was removed using the 8.4-mm Amoils brush (Innovative Excimer Solutions), and various laser beam platforms were permitted for the surgery. Investigated drugs were applied after a bandage contact lens (Acuvue Oasys, Johnson & Johnson Vision Care) was fitted. All patients received postoperative cold saline (balanced saline solution [BSS]), prednisolone acetate 1.0% (Pred Forte, Allergan), gatifloxacin ophthalmic solution 0.3% (Zymar, Allergan), and in some cases, mitomycin C 0.02% (MMC). Patients recorded postoperative results for pain, photophobia, burning, and foreign-body sensation on a visual linear analog scale. During postoperative follow-up, the corneal epithelial defect was measured. RESULTS: Two hundred twelve eyes from 149 patients were enrolled in the study. Of these eyes, 105 received bromfenac and 107 received ketorolac. No significant differences were noted in postoperative pain, burning, foreign-body sensation, and photophobia between the two drug populations at any time during the study or overall. There were no drug-related adverse events or differences in epithelial healing rates for either drug. CONCLUSIONS: No significant differences were observed between the use of bromfenac (twice daily) and ketorolac (four times daily) with regard to postoperative PRK discomfort and safety when combined with postoperative measures such as cold BSS and a bandage contact lens.

The Clinical Relationship of Anterior Capsular Tears and Vertical Spacing in the Femtosecond Laser Capsulotomy Procedure.

PURPOSE: To evaluate the frequency of anterior capsule tears and capsule edge irregularities in femtosecond laser anterior capsulotomy, including the effect of optimized vertical spacing settings. METHODS: Three thousand eight hundred thirty-four cases were examined and grouped according to the femtosecond laser capsulotomy settings using manufacturer default settings with a vertical spacing of 10, 15, and 20 µm. Capsulotomy edge irregularities and anterior capsule tears were recorded intraoperatively. RESULTS: The anterior capsule tear rates for the 10, 15, and 20 µm groups were 0.79%, 0.35%, and 0.09%, respectively. The capsule edge irregularity rates for the 10, 15, and 20 µm groups were 6.25%, 1.13%, and 1.15%, respectively. The treatment times for the 10, 15, and 20 µm groups were 1.6, 0.7, and 0.8 second, respectively. The risk reduction of anterior capsule tears positively correlated with the 15 and 20 µm group settings. The anterior capsule tear rate difference between the 10 and 20 µm group settings was statistically significant. Capsule edge irregularity rates were reduced in the 15 and 20 µm group settings. Eye movement was monitored in the 20 µm group and was observed in 9 of 13 patients with capsule edge irregularities. CONCLUSIONS: Anterior capsule tear rates are low with femtosecond laser cataract surgery. The rate can be further reduced with optimization of the settings, including an increase in vertical spacing. [J Refract Surg. 2019;35(5):280-284.].

Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study.

PURPOSE: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. DESIGN: Cohort study within a multi-center, double-masked, randomized clinical trial. METHODS: 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals). RESULTS: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm2, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD. CONCLUSIONS: Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.

Case Report: Ocular Gnathostomiasis in Venezuela Most Likely Acquired in Texas.

A 69-year-old male dentist in Caracas, Venezuela, was referred to our Cornea Clinic with a history of pain, photophobia, and blurred vision on his left eye. Routine biomicroscopic examination with a slit lamp showed a worm in the corneal stroma of his left eye. The worm was surgically removed and was identified morphologically as Gnathostoma binucleatum.

Necrotizing nocardial scleritis after combined penetrating keratoplasty and phacoemulsification with intraocular lens implantation: a case report and review of the literature.

We report the history and clinical presentation of an 88-year-old female with Fuchs dystrophy who developed an acute anterior necrotizing scleritis in her left eye 23 months after an uncomplicated combined penetrating keratoplasty and phacoemulsification with intraocular lens implantation which progressed to slceral perforation with uveal prolapses. The patient underwent a complete systemic work-up for both autoimmune and infectious causes of scleritis. Surgical specimens of the area of scleral perforation were sent for histology and microbiologic studies. Analysis of surgical specimens revealed the presence of culture-proven Nocardia asteroides as a causative agent for the patient's scleral perforation. Results of her systemic autoimmune work-up were not conclusive. Successful treatment with tectonic scleral reinforcement with donor corneal tissue and preserved pericardium, oral and topical trimethoprim-sulfamethoxazole and topical amikacin salvaged the globe and increased vision. The patient's final best-corrected visual acuity sixteen months after her last operation remains 20/70. Prompt surgical intervention with submission of appropriate specimens for pathological diagnosis and microbiology, along with consultation with rheumatologic and infectious disease specialists, are mandatory to minimize visual loss in cases of suspected infectious necrotizing scleritis.

The RPS adeno detector for diagnosing adenoviral conjunctivitis.

PURPOSE: To compare the sensitivity, specificity, and accuracy of the RPS Adeno Detector (Rapid Pathogen Screening Inc., South Williamsport, PA) against both viral cell culture with confirmatory immunofluorescence staining (CC-IFA) and the polymerase chain reaction (PCR) for diagnosing adenoviral conjunctivitis. DESIGN: Prospective, nonrandomized, masked, multicenter clinical trial. PARTICIPANTS: One hundred eighty-six consecutive patients from 5 clinical centers seeking treatment within 1 week of developing a red eye and thought to have acute conjunctivitis. METHODS: The RPS Adeno Detector is a 10-minute in-office lateral flow immunoassay. Patients were tested with the RPS Adeno Detector, CC-IFA, and PCR to detect the presence of adenovirus. MAIN OUTCOME MEASURES: The sensitivity, specificity, and accuracy of the RPS Adeno Detector were assessed for identifying cases of adenoviral conjunctivitis. RESULTS: Compared with CC-IFA, the RPS Adeno Detector was 88% sensitive and 91% specific at detecting adenoviral conjunctivitis. Using PCR as a reference method, the sensitivity of the RPS Adeno Detector increased to 89% and the specificity increased to 94%. Compared with PCR, CC-IFA was found to be 91% as sensitive and 100% as specific. CONCLUSIONS: The RPS Adeno Detector demonstrated sufficient sensitivity and specificity to be used in the physician's office for the detection of adenoviral conjunctivitis.

Bacillus megaterium delayed onset lamellar keratitis after LASIK.

PURPOSE: To report the history and clinical presentation of a 23-year-old man who developed delayed onset lamellar keratitis in his right eye 2 weeks after uneventful LASIK for correction of myopia. METHODS: Initial clinical presentation suggested an infectious etiology, which led to therapeutic elevation of the LASIK flap and further microbiologic investigation with bacterial cultures. RESULTS: Bacterial cultures revealed Bacillus megaterium, which was sensitive to all antibiotics against which it was tested. Twenty-four hours after initiating aggressive topical and oral antibiotic therapy, symptomatic relief occurred in the affected eye. The patient's uncorrected final visual acuity at 1-year follow-up was 20/15 in the right eye, and the stromal bed developed a faint peripheral non-visually significant scar. CONCLUSIONS: This case is an unusual presentation and course for microbial keratitis following LASIK, which occurred despite aseptic technique and fluoroquinolone antibiotic prophylaxis. Following refractive surgery one should be prepared to culture the lamellar interface in cases of suspected microbial keratitis and begin aggressive antibiotic therapy.

Comparison of vitreous loss rates between manual phacoemulsification and femtosecond laser-assisted cataract surgery.

PURPOSE: To compare the vitreous loss complication rate of manual phacoemulsification cataract surgery with that of femtosecond laser-assisted cataract surgery. SETTING: Mercy Eye Specialists, Springfield, Missouri, USA. DESIGN: Retrospective single-center case series. METHODS: Cataract surgeries from 2010 to 2014 performed by 4 surgeons were audited for rates of vitreous loss. Vitreous loss data were statistically analyzed with and without exclusions. RESULTS: Of the total 7155 cases from 2010 to 2014, 3784 were consecutively performed using manual phacoemulsification from 2010 to 2012 and 3371 were performed using femtosecond laser-assisted cataract surgery from 2013 to 2014. The rate of vitreous loss with exclusions was 1.17% in the manual phacoemulsification group and versus 0.65% femtosecond laser-assisted group; without exclusions, the rate was 1.40% versus 0.77%. In absolute terms, the rate decreased for every surgeon in the study. The chi-square test showed a statistically significant association between the date of surgery, and thus technique, and vitrectomy cases (P < .05). Odds ratio analysis with exclusions versus without exclusions indicated that surgeries performed from 2010 to 2012 using manual phacoemulsification were 1.6 times and 1.8 times, respectively, more likely to have vitreous loss than surgeries performed from 2013 to 2014 using the femtosecond laser-assisted cataract surgery technique. CONCLUSIONS: Conversion from manual phacoemulsification to femtosecond laser-assisted cataract surgery resulted in a statistically significant decrease in vitreous loss. Because vitreous loss increases the risk for other serious complications of cataract surgery, this new finding has important implications for the safety of cataract surgery. FINANCIAL DISCLOSURE: Proprietary or commercial disclosures are listed after the references.

Considerations of glaucoma in patients undergoing corneal refractive surgery.

Glaucoma patients present a unique set of challenges to physicians performing corneal refractive surgery. Corneal thickness, which is modified during corneal refractive surgery, plays an important role in monitoring glaucoma patients because of its effect on the measured intraocular pressure. Patients undergo a transient but significant rise in intraocular pressure during the laser-assisted in situ keratomileusis (LASIK) procedure with risk of further optic nerve damage or retinal vein occlusion. Glaucoma patients with filtering blebs are also at risk of damage to the bleb by the suction ring. Steroids, typically used after refractive surgery, can increase intraocular pressure in steroid responders, which is more prevalent among glaucoma patients. Flap interface fluid after LASIK, causing an artificially low pressure reading and masking an elevated pressure has been reported. The refractive surgeon's awareness of these potential complications and challenges will better prepare them for proper management of glaucoma patients who request corneal refractive surgery.

Mycobacterium chelonae-Mycobacterium abscessus complex clear corneal wound infection with recurrent hypopyon and perforation after phacoemulsification and intraocular lens implantation.

We report a clear corneal wound infection occurring in a 74-year-old man caused by a member of the Mycobacterium chelonae-Mycobacterium abscessus complex, presenting as crystalline keratopathy with recurrent hypopyon. This led to perforation after phacoemulsification with posterior chamber intraocular lens implantation. Only after corneal biopsy of the incision was the causative organism isolated and found to be sensitive to clarithromycin and ciprofloxacin. Despite aggressive therapy, a full-thickness corneal perforation developed, requiring emergent cyanoacrylate glue to preserve ocular integrity. Both the difficulty and delays in obtaining a correct diagnosis led to severe ocular morbidity. Infectious lamellar keratitis limited to the clear cornea phacoemulsification incision is rare, but some unusual organisms such as atypical mycobacteria may be encountered.

Bilateral intraocular foreign bodies simulating crystalline lens.

PURPOSE: To report a case of large bilateral intraocular foreign bodies mistaken for crystalline lens on computed tomography (CT). DESIGN: Case report. METHODS: A 24-year-old man was referred after bilateral open globe repair following a motor vehicle accident. Preoperatively, the CT scan had been read as "Right eye posteriorly dislocated lens. No evidence of foreign bodies." RESULTS: The patient underwent left eye cataract extraction with removal of a 7 x 5 x 5 mm piece of glass buried in the crystalline lens. The patient subsequently underwent right eye pars plana vitrectomy, removal of another piece of glass measuring 6 x 5 x 5 mm, retinal detachment surgery, and corneal grafting. CONCLUSIONS: Current safety standards require auto glass to fracture into pieces of a specific size to minimize laceration and missile injury. These pieces of glass may have a shape and size similar to the crystalline lens but have higher radiodensity on CT scan.

Effect of mild to moderate myopic correction by laser-assisted in situ keratomileusis on intraocular pressure measurements with goldmann applanation tonometer, tono-pen, and pneumatonometer.

PURPOSE: To evaluate the effect of mild to moderate myopic correction by laser-assisted in situ keratomileusis (LASIK) on intraocular pressure (IOP) measurements with three tonometers: the Goldmann applanation tonometer, Tono-Pen, and pneumatonometer. PATIENTS AND METHODS: In a prospective study of a clinic-based population undergoing elective LASIK surgery for myopia correction, IOP measurements were obtained preoperatively and postoperatively with a Goldmann applanation tonometer, Tono-Pen, and pneumatonometer. Central corneal thickness and keratometric and astigmatism measurements were also obtained before and after surgery. A paired test was used to evaluate the significance of differences between preoperative and postoperative IOP measurements with each instrument. Linear regression was used to correlate IOP measurements with degree of myopia corrected, astigmatism, and central corneal thickness before and after surgery. RESULTS: The study included 66 eyes of 34 individuals with a mean preoperative refractive error of -5.66 + 2.3 D (mean + SD). The reduction of central corneal thickness after LASIK of 0.032 + 0.030 mm (mean + SD) was statistically significant ( < 0.0001). However, there was no statistically significant change in mean IOP after the procedure with the Goldmann applanation tonometer or the Tono-Pen, while the pneumatonometer, was associated with a small but statistically significant decrease in mean IOP of 1.1 mm Hg. CONCLUSION: In this group of patients with mild to moderate myopia, LASIK had little or no statistically significant influence on IOP readings obtained with a Goldmann applanation tonometer, Tono-Pen, or pneumatonometer. This finding is in contrast to earlier reports of greater amounts of myopic correction, in which significant reductions in measured IOP were observed. Further study is needed to determine whether a critical amount of corneal change after LASIK is required to have a significant effect on IOP measurements.

Prospective, multicenter, clinical evaluation of point-of-care matrix metalloproteinase-9 test for confirming dry eye disease.

PURPOSE: The aim of this study was to determine the negative and positive agreement of a point-of-care matrix metalloproteinase-9 test in confirming the diagnosis of dry eye and to evaluate the ease of use by untrained ophthalmic technicians. METHODS: The study was a prospective, sequential, masked, clinical trial with 4 clinical trial sites. The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test. RESULTS: The study enrolled 237 patients. If the OSDI is included in the definition for mild dry eye, the InflammaDry test was shown to have a total positive agreement of 81% (127/157) and a negative agreement of 98% (78/80). The removal of the OSDI shifted the categorization of 11 patients previously considered positive for dry eye to become categorized as negative for dry eye. If the OSDI is excluded from the definition of dry eye, the InflammaDry test demonstrates a positive agreement of 86% (126/146) and a negative agreement of 97% (88/91) against the clinical assessment. CONCLUSIONS: The InflammaDry test demonstrates a high positive and negative agreement for confirming suspected dry eye disease. In addition, the test was safely and effectively performed by untrained operators. These findings support the intended use of the InflammaDry test as an aid in the diagnosis of dry eye.

Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis.

OBJECTIVE: To compare the clinical sensitivity and specificity of the AdenoPlus test with those of both viral cell culture (CC) with confirmatory immunofluorescence assay (IFA) and polymerase chain reaction (PCR) at detecting the presence of adenovirus in tear fluid. METHODS: A prospective, sequential, masked, multicenter clinical trial enrolled 128 patients presenting with a clinical diagnosis of acute viral conjunctivitis from a combination of 8 private ophthalmology practices and academic centers. Patients were tested with AdenoPlus, CC-IFA, and PCR to detect the presence of adenovirus. MAIN OUTCOME MEASURES: The sensitivity and specificity of AdenoPlus were assessed for identifying cases of adenoviral conjunctivitis. RESULTS: Of the 128 patients enrolled, 36 patients' results were found to be positive by either CC-IFA or PCR and 29 patients' results were found to be positive by both CC-IFA and PCR. When compared only with CC-IFA, AdenoPlus showed a sensitivity of 90% (28/31) and specificity of 96% (93/97). When compared only with PCR, AdenoPlus showed a sensitivity of 85% (29/34) and specificity of 98% (89/91). When compared with both CC-IFA and PCR, AdenoPlus showed a sensitivity of 93% (27/29) and specificity of 98% (88/90). When compared with PCR, CC-IFA showed a sensitivity of 85% (29/34) and specificity of 99% (90/91). CONCLUSION: AdenoPlus is sensitive and specific at detecting adenoviral conjunctivitis. APPLICATION TO CLINICAL PRACTICE: An accurate and rapid in-office test can prevent the misdiagnosis of adenoviral conjunctivitis that leads to the spread of disease, unnecessary antibiotic use, and increased health care costs. Additionally, AdenoPlus may help a clinician make a more informed treatment decision regarding the use of novel therapeutics. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00921895.

Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye.

OBJECTIVES: To determine the clinical sensitivity, specificity, negative predictive value, and positive predictive value of a rapid point-of-care diagnostic test to detect elevated matrix metalloproteinase 9 levels (InflammaDry). METHODS: In a prospective, sequential, masked, multicenter clinical trial, InflammaDry was performed on 206 patients: 143 patients with clinical signs and symptoms of dysfunctional tear syndrome (dry eyes) and 63 healthy individuals serving as controls. Participants were assessed as healthy controls or for a clinical diagnosis of dry eye using the Ocular Surface Disease Index, Schirmer tear test, tear breakup time, and keratoconjunctival staining. MAIN OUTCOME MEASURES: The sensitivity and specificity of InflammaDry were compared with clinical assessment. RESULTS: InflammaDry showed sensitivity of 85% (in 121 of 143 patients), specificity of 94% (59 of 63), negative predictive value of 73% (59 of 81), and positive predictive value of 97% (121 of 125). CONCLUSION: Compared with clinical assessment, InflammaDry is sensitive and specific in diagnosing dry eye. APPLICATION TO CLINICAL PRACTICE: Dry eye is often underdiagnosed resulting from poor communication between the clinical assessment of dry eye severity between clinicians and patients. This often leads to a lack of effective treatment. Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of patients with dry eyes. The ability to accurately detect elevated matrix metalloproteinase 9 levels may lead to earlier diagnosis, more appropriate treatment, and better management of ocular surface disease. Preoperative and perioperative management of inflammation related to dry eyes may reduce dry eyes that develop after laser in situ keratomileusis, improve wound healing, and reduce flap complications. Recognition of inflammation may allow for targeted perioperative therapeutic management of care for patients who undergo cataract and refractive surgery and improve outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01313351.

Precise temperature control of donor cornea tissue with reusable passive thermal container.

PURPOSE: To describe a new reusable passive thermal shipping container for domestic and international transport of human donor cornea, which maintains air temperature for 72 consecutive hours of harsh hypothermic and hyperthermic environmental challenges. METHODS: The passive thermal container (PTC) was prepared by storing the device at -30°C for 8 hours. On full activation of the biphasic wax-based compound, 2 human corneas for research and future histological studies were secured in either of 2 similarly prepared PTCs or 2 polystyrene containers with wet ice. Three thermal data loggers were enclosed in the bottom, side, and middle of each payload area. The container was then exposed to hyperthermic (range, 21.1 to 51.7°C) or hypothermic (range, 15.6 to -28.9°C) external temperatures for 72 hours after which all corneas were removed, and the air temperature readings from the loggers were reviewed. RESULTS: Air temperature stability was measured at 5-minute intervals. The PTC maintained steady acceptable air temperatures for 71.13 consecutive hours in the hyperthermic challenge and 60.33 consecutive hours in the hypothermic challenge. The polystyrene containers with wet ice did not maintain a payload temperature between 2 and 8°C for more than 8 consecutive hours during the hypothermic challenge and never achieved industry regulation temperatures during the hyperthermic challenge. CONCLUSIONS: We present a novel method for transporting human corneal tissue that ensures proper air temperature stability between 60 and 71 hours in harsh hypothermic and hyperthermic environments, which is also reusable. There may be applications for this technology in both domestic and international transportation of corneal tissue.

Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis.

INTRODUCTION: An alternative formulation of 0.5% moxifloxacin ophthalmic solution (Moxeza, MOXI-AF, Alcon Laboratories, Inc., Fort Worth, TX, USA) containing xanthan gum to prolong retention on the eye has been developed. MOXI-AF was designed to optimize the treatment regimen for bacterial conjunctivitis for the convenience of the patient with twice-daily dosing. METHODS: A safety and efficacy clinical study was conducted as a multicenter, vehiclecontrolled, randomized, double-masked, parallel group study in clinically diagnosed bacterial conjunctivitis patients aged >28 days. MOXI-AF or its vehicle was dosed one drop twice-daily for 3 days. Microbiological specimens were obtained from affected eyes on day 1, prior to the initial dose, and on day 4 after 3 days of dosing, and processed using routine clinical microbiology laboratory methods. All recovered bacteria were identified to the species level. RESULTS: This paper reports on the microbiological success rate, a secondary efficacy variable in the trial. All patients (1180) were randomized to treatment. Patient age ranged from 30 days to 92 years. The microbiological success rate for patients treated topically with MOXI-AF twice-daily for 3 days was 74.5%, compared with 56.0% of patients treated with its vehicle control (P<0.0001). MOXI-AF was also statistically more effective than vehicle in eradicating the three principle conjunctivitis pathogens, Haemophilus influenzae (98.5% vs. 59.6%, respectively), Streptococcus pneumoniae (86.4% vs. 50.0%, respectively), and Staphylococcus aureus (94.1% vs. 80.0%, respectively) (P<0.001). CONCLUSION: The xanthan gum-based 0.5% moxifloxacin ophthalmic formulation, MOXI-AF, provides effective eradication of the three principle causative pathogens of bacterial conjunctivitis across all age groups when dosed twice-daily for 3 days.