Upper Eyelid and Pupillary Effects of Topical Dilute Epinephrine.

PURPOSE: Adrenergic medications may elevate the upper eyelid and dilate the pupil. The effects of topical phenylephrine on Müller's muscle have been well described. Dilute epinephrine (DE) is a sympathomimetic agent commonly administered in blepharoptosis surgery, and has been shown to elevate the upper eyelid margin when injected subcutaneously. The effects of DE applied topically to the eye, whether intentional or inadvertent during surgery have not been characterized. The purpose of this investigation was to quantify and compare the effects of topical DE and phenylephrine on upper eyelid position and pupil size. METHODS: Prospective, nonrandomized trial of 41 adults without (n = 25, 25 eyes) and with ptosis (n = 16, 16 eyes). Upper eyelid margin reflex distance (MRD1) and pupil diameter were primary measures and pupil reactivity to light was a secondary measure. MRD1 and pupil diameter were recorded at baseline and at 30-second intervals for 5 minutes after administration of topical 1% lidocaine with epinephrine 1:100,000 (DE). After a washout period of >24 hours, the same measurements were recorded after administration of topical phenylephrine 2.5%. RESULTS: No statistically significant difference was observed between mean baseline and postexposure MRD1 after application of topical DE (p = 0.181). In contrast, a mean increase in MRD1 of 0.51 ± 0.09 mm (effect size 0.33) was observed after exposure to phenylephrine 2.5% (p < 0.001). Baseline-adjusted postexposure mean MRD1 was significantly greater for phenylephrine compared with DE (p < 0.001, analysis of covariance). Mean pupil diameter increased 0.29 ± 0.09 mm (effect size 0.48) in response to DE and 0.27 ± 0.11 mm (effect size 0.41) after application of phenylephrine (p = 0.004 and p = 0.001, respectively). All pupils maintained a constrictive response to light. CONCLUSIONS: Although DE is similar to topical phenylephrine in causing mydriasis, it did not have a similar effect on elevating the upper eyelid. These findings may have implications on intraoperative assessment during eyelid surgery. The pupillary changes due to DE offer one explanation for cases of transient pupil dilation during orbitofacial surgery.

A Randomized Controlled Trial Comparing Subconjunctival Injection to Direct Scleral Application of Mitomycin C in Trabeculectomy.

PURPOSE: To compare the efficacy of intraoperative scleral application with subconjunctival injection of mitomycin C (MMC) in trabeculectomy. DESIGN: Prospective, randomized, interventional study. METHODS: This study took place in a single clinical practice in an academic setting. Patients had medically uncontrolled glaucoma as indicated by high intraocular pressure (IOP), worsening visual field, or optic nerve head changes in whom primary trabeculectomy was indicated. Patients were older than 18 years with medically uncontrolled glaucoma and no history of incisional glaucoma surgery. Patients were randomized to MMC delivered by preoperative subconjunctival injection or by intraoperative direct scleral application using surgical sponges during trabeculectomy. Comprehensive eye examinations were conducted at 1 day, 1 week, 6 weeks, 3 months, and 6 months postoperatively. Subconjunctival 5-fluorouracil injections were given postoperatively, as needed. The primary outcome was the proportion of patients who demonstrated IOP of <21 mm Hg and ≥30% reduction in IOP from baseline. Secondary outcome measures included the number of IOP-lowering medications, bleb morphology using the Indiana Bleb Appearance Grading Scale, and complication rates. RESULTS: Participants (n = 100) were randomized into groups matched for baseline demographics, glaucoma status, and baseline IOP. At 6 months, there were no significant differences between the injection (n = 38) and sponge (n = 40) groups in surgical success (P = .357), mean IOP (P = .707), number of glaucoma medications (P = 1.000), bleb height (P = .625), bleb extension (P = .216), bleb vascularity (P = .672), or complications rates. CONCLUSION: Both techniques of MMC delivery (subconjunctival injection and direct scleral application) resulted in comparable surgical outcomes and bleb morphologies.

A randomized trial of multimedia-facilitated informed consent for cataract surgery.

OBJECTIVE: The aim of this study was to evaluate the value and role of patient's education videos in the informed consent process for patients undergoing preoperative assessment of cataracts. DESIGN: The study is a single-center prospective randomized controlled trial. SUBJECTS PARTICIPANTS AND/OR CONTROLS: Participants enrolled in this study were specifically those undergoing first-time phacoemulsification cataract surgery with the placement of a monofocal lens implant. PARTICIPANTS AND METHODS: Subjects were randomized to either face-to-face surgeon-informed consent with a preceding education video or face-to-face surgeon-informed consent alone. MAIN OUTCOME MEASURES: The main outcome measures assessed were time to complete the informed consent process, patient's satisfaction, and patient's comprehension. RESULTS: The video and control groups were similar in satisfaction (4.67±0.104 video vs. 4.53±0.133 control; P=0.43) and comprehension (79.4%±2.82% video vs. 79.3%±3.39% control; P=0.99). Counseling time was statistically significantly different (117.5±10.9 seconds video versus 241.6±13.0 seconds control; P<0.0001). CONCLUSION: Use of a patient's education video for cataract surgery was associated with reduced physician counseling time yet similar comprehension and patient-reported satisfaction when compared with traditional counseling methods.

Fluorescein Aqueous Angiography in Live Normal Human Eyes.

PURPOSE: To evaluate aqueous humor outflow (AHO) in intact eyes of live human subjects during cataract surgery using fluorescein aqueous angiography. METHODS: Aqueous angiography was performed in 8 live human subjects (56 to 86 y old; 2 men and 6 women). After anesthesia, fluorescein (2%) was introduced into the eye [either alone or after indocyanine green (ICG; 0.4%)] from a sterile, gravity-driven constant-pressure reservoir. Aqueous angiographic images were obtained with a Spectralis HRA+OCT and FLEX module (Heidelberg Engineering). Using the same device, anterior-segment optical coherence tomography (OCT) and infrared images were also concurrently taken with aqueous angiography. RESULTS: Fluorescein aqueous angiography in the live human eye showed segmental AHO patterns. Initial angiographic signal was seen on average by 14.0±3.0 seconds (mean±SE). Using multimodal imaging, angiographically positive signal colocalized with episcleral veins (infrared imaging) and intrascleral lumens (anterior-segment OCT). Sequential aqueous angiography with ICG followed by fluorescein showed similar segmental angiographic patterns. DISCUSSION: Fluorescein aqueous angiography in live humans was similar to that reported in nonhuman primates and to ICG aqueous angiography in live humans. As segmental patterns with sequential angiography using ICG followed by fluorescein were similar, these tracers can now be used sequentially, before and after trabecular outflow interventions, to assess their effects on AHO in live human subjects.

Critical evaluation of latanoprostene bunod in the treatment of glaucoma.

Latanoprostene bunod (LBN) is a novel nitric oxide-donating prostaglandin F2α receptor agonist in clinical development for intraocular pressure lowering in open-angle glaucoma and ocular hypertension. Currently in Phase III clinical trials in the USA, European Union, and Japan, LBN has demonstrated promising efficacy while maintaining safety and tolerability. We review preclinical and clinical developmental efforts and evaluate the potential role of LBN monotherapy in the management of open-angle glaucoma and ocular hypertension. The current LBN clinical development program comprises eight trials, four of which have resulted in publication of complete methodology and outcomes. We additionally pool adverse events data to determine incidences across three pivotal studies. Evidence thus far indicates that LBN may be a safe and effective ocular hypotensive agent, although the potential neuroprotective effects and the impact on visual field loss remain to be evaluated.

Outcome of primary trabeculotomy ab interno (Trabectome) surgery in patients with steroid-induced glaucoma.

To determine the efficacy and safety of Trabectome surgery on patients with steroid response, ranging from ocular hypertension refractory to maximal medical therapy to the development of steroid-induced glaucoma.A nonrandomized, nonblinded, retrospective study of 20 subjects with steroid response was conducted. All 20 eyes underwent Trabectome surgery alone. Nine subjects had steroid response with unremarkable visual field, 3 had mild steroid-induced glaucoma, and 8 had advanced steroid-induced glaucoma. Outcome measures included intraocular pressure (IOP), number of glaucoma medications, need for secondary glaucoma surgery, and steroid regimen. Mann-Whitney U test was used to compare postoperative IOP and number of medications to preoperative IOP and number of medications. Kaplan-Meier was used for survival analysis, and success was defined as: IOP reduced by 20% or more on any 2 consecutive visits after 3 months; IOP ≤21 mm Hg on any 2 consecutive visits after 3 months; and no secondary glaucoma surgery.The average preoperative IOP was 33.8 ±â€Š6.9 mm Hg and average preoperative glaucoma medication usage was 3.85 ±â€Š0.75 medications. At 12 months, the IOP was reduced to 15.00 ±â€Š3.46 mm Hg (P = 0.03) and glaucoma medication was reduced to 2.3 ±â€Š1.4 (P < 0.01). The survival rate at 12 months was 93%. At 12 months, 10 patients were continued on their preoperative steroid treatments, 5 were on tapered steroid treatments, and 5 had ceased steroid treatments entirely. One patient required secondary glaucoma surgery (glaucoma drainage device). No other complications were noted.The Trabectome procedure is safe and highly effective for steroid-response glaucoma, even in the context of continued steroid treatment.

Imaging in orbital trauma.

Orbital trauma is one of the most common reasons for ophthalmology specialty consultation in the emergency department setting. We survey the literature from 1990 to present to describe the role of computed tomography (CT), magnetic resonance imaging (MRI) and their associated angiography in some of the most commonly encountered orbital trauma conditions. CT orbit can often detect certain types of foreign bodies, lens dislocation, ruptured globe, choroidal or retinal detachments, or cavernous sinus thrombosis and thus complement a bedside ophthalmic exam that can sometimes be limited in the setting of trauma. CT remains the workhorse for acute orbital trauma owing to its rapidity and ability to delineate bony abnormalities; however MRI remains an important modality in special circumstances such as soft tissue assessment or with organic foreign bodies.

Implementation of good clinical practice guidelines in vaccine trials in developing countries.

The practicalities when applying the ICH GCPs (International Conference on Harmonization 1996 Good Clinical Practices [EU, MHLW, FDA. International Conference on Harmonization Guideline for Good Clinical Practice; 1997] in less developed countries (ldcs) are seldom discussed and we found no guidelines as how to "adapt" them. Below we illustrate how ICH GCP principles can be implemented in different settings. We have recently conducted in Asia (Hechi, China; Karachi, Pakistan; Hue, Vietnam; North Jakarta, Indonesia and Kolkata, India) large-scale cluster-randomized effectiveness evaluations of the Vi polysaccharide typhoid fever vaccine (Vi PS project) among approximately 200,000 individuals(1)[Acosta CJ, Galindo CM, Ali M, Abu-Elyazeed R, Ochiai RL Danovaro-Holliday MC et al. A multi-country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design. TMIH 2005;10(12):1219-1228]. There is no doubt on the importance of ICH GCP in its contribution to ethical and scientifically sound clinical research. However, when the ICH GCP is implemented in ldcs some considerations must be made in order to adequately tailor them. Vaccine trials in ldcs are a frequent setting for such challenges because of the increased global interest conducting health research in such countries. The ICH GCP principles are discussed below within the framework of this recent typhoid fever vaccine study experience.