Michael A Lemp

Georgetown University | GU · Department of Ophthalmology

Purpose: To identify factors contributing to the inadequacies of systematic reviews and meta-analyses (SRMAs) published in the ophthalmology literature. Design: Perspective METHODS: Review and synthesis of selective literature, with interpretation and perspective. Results: While recommendations for the design, conduct, and assessment of qualit...

One of the most common disorders of the ocular surface is dry eye disease (DED). A historical perspective of our understanding of DED can be captured in seven thematic areas. Structure and function of the components of the tear film and ocular surface and the lacrimal functional unit provide the basic information. The hallmarks of DED are tear inst...

The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective...

Dry eye disease (DED) is a common, multifactorial ocular condition with major impact on vision and quality of life. It is now well recognized that the pathophysiology of chronic DED can include a cycle of inflammation involving both innate and adaptive immune responses. Recently, in vitro/in vivo models have been used to obtain a better understandi...

To provide a consensus clinical guideline for management of dry eye disease associated with Sjögren disease by evaluating published treatments and recommending management options. Consensus panel evaluation of reported treatments for dry eye disease. Using the 2007 Report of the International Workshop on Dry Eye (DEWS) as a starting point, a panel...

Publication of the DEWS report in 2007 established the state of the science of dry eye disease (DED). Since that time, new evidence suggests that a rethinking of traditional concepts of dry eye disease is in order. Specifically, new evidence on the epidemiology of the disease, as well as strategies for diagnosis, have changed the understanding of D...

Evaluation of: Jacobi C, Jacobi A, Kruse FE, Cursiefen C. Tear film osmolarity measurements in dry eye disease using electrical impedance technology. Cornea 30(12), 1289–1292 (2011). In the study by Jacobi et al. the authors evaluated the clinical utility of a new office-based test for tear osmolarity in the diagnosis of dry eye disease. TearLab™ t...

Introduction Maxillary Sinuses Frontal Sinuses Sphenoidal Sinuses Ethmoidal Sinuses Development of the Paranasal Sinuses Clinical Notes Clinical Problems Answers to Clinical Problems

Introduction Orbital Margin Walls of the Orbital Cavity Openings into the Orbital Cavity and the Structures That Pass Through Them Relations of the Bony Orbit The Periorbita or Orbital Periosteum (Orbital Fascia) Orbital Muscle (Muscle of Müller) Effect of Age on the Orbital Cavity Sex Differences in the Orbital Cavities Surface Anatomy of the Orbi...

Definition of the Visual Pathway Anatomy of the Visual Pathway Overview of the Retinotopic Organization of the Visual Pathway Other Areas of the Cerebral Cortex Associated with Sight The Visual Pathway and Visual Reflexes Clinical Notes Clinical Problems Answers to Clinical Problems

Composition Anterior View Lateral View Posterior View Superior View Inferior View The Cranial Cavity The Meninges The Venous Blood Sinuses Clinical Notes Development of the Skull The Neonatal Skull Clinical Notes Radiographic Appearance Clinical Problems Answers to Clinical Problems

Introduction The Eyeball The Extraocular Muscles Accessory Eye Structures The Orbit Postnatal Growth Senile Changes in the Eye Clinical Notes Clinical Problems Answers to Clinical Problems

Arteries of the Orbit Clinical Notes Veins of the Orbit Clinical Notes Clinical Problems Answers to Clinical Problems

Support of the Eyeball During Eye Movements Position of the Eyeball Terms Used in Describing Eye Movements Axes of Rotation of the Eyeball Muscles Producing Movements of the Eyeball Clinical Notes Movements of the Eyeballand the Muscles Used in Producing the Movements Additional Terminology Used in Describing the Movements of Both Eyeballs Clinical...

Introduction Nerves of the Orbital Cavity Sensory Nerves Clinical Notes Clinical Problems Answers to Clinical Problems

The Direct Ophthalmoscope The Slit Lamp Gonioscopy Clinical Problems Answers to Clinical Problems

Fascial Sheath of the Eyeball (Fascia Bulbi , Tenon's Capsule) The Eyeball Refractive Media of the Eye Clinical Problems Answers to Clinical Problems

Introduction The Sensory Nerves Clinical Notes Vestibulocochlear Nerve (Cranial Nerve VIII) The Motor Nerves The Motor and Sensory Nerves Clinical Problems Answers to Clinical Problems

The Eyebrows The Eyelids Conjunctiva Lacrimal Apparatus Clinical Problems Answers to Clinical Problems

Organization of the Autonomic Nervous System Sympathetic Part of the Autonomic Nervous System Parasympathetic Part of the Autonomic Nervous System The Large Autonomic Plexuses Structure of Autonomic Ganglia Preganglionic Transmitters Ganglion Blocking Agents Structure of Postganglionic Nerve Endings Postganglionic Transmitters Blocking of Cholinerg...

Purpose: To evaluate the relationship between signs and symptoms of dry eye disease (DED) in a clinic-based population. Methods: In a retrospective analysis, clinical signs and symptoms were evaluated for 344 subjects (n = 82, normal; n = 263, dry eye), across 11 sites from the EU and United States. Pearson correlations between signs and symptom...

To evaluate the efficacy of commonly used biomarkers in dry eye disease management in a longitudinal observational case series study followed by an interventional study in a subset of subjects treated with cyclosporine A (0.05%). Bilateral tear osmolarity, Schirmer, tear film breakup time (TBUT), staining, meibomian grading, and Ocular Surface Dise...

To evaluate in a general clinic-based cohort of patients with dry eye disease (DED) the distribution of patients with aqueous-deficient or evaporative subtype of DED. Schirmer tests and meibomian gland dysfunction (MGD) (Foulks-Bron scoring) were evaluated in both eyes of 299 normal subjects and DED patients (218 women and 81 men) across 10 sites i...

To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD). This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC contro...

Dry eye disease is a multifactorial chronic disorder of the ocular surface that affects up to 100 million people worldwide. During the pathogenesis of dry eye, impaired function of the lacrimal and meibomian glands results in hyposecretion of aqueous tear fluid, coupled with increased evaporation and instability of the tear film, which becomes incr...

Purpose The relationship between ocular surface inflammation, signs and symptoms in DED remains poorly understood. A correlation between ocular surface inflammation and CFS in DED patients is reported. Methods DED patients with tear break up time ≤8 seconds and CFS grades 2‐4 modified Oxford scale and Schirmer test without anesthesia ≥2 and <10 mm/...

Benzalkonium chloride (BAK) is the principal preservative employed in topical ocular hypotensive medications, although alternative compounds recently have begun to be employed or examined. Individual clinical trials have shown that exposure to BAK concentrations contained in ophthalmic solutions does not produce adverse sequelae in the majority of...

DED is a multifactorial disease of the tears associated with inflammation of the ocular surface. The diagnosis and treatment of DED relies on clinical signs and subjective patient symptoms common to other ocular surface conditions. Although a poor concordance between DED signs and symptoms has been recognized in the literature, improvement in both...

Supported by the Tear Film and Ocular Surface Society (TFOS; http://www.tearfilm.org); individual author support is listed in the Appendix of the Introduction. Disclosure: Each Workshop Participant's disclosure data can be found in the Appendix of the Introduction.

To evaluate the use of tear osmolarity in the diagnosis of dry eye disease. A prospective, observational case series to determine the clinical usefulness of tear osmolarity and commonly used objective tests to diagnose dry eye disease. A multicenter, 10-site study consisting of 314 consecutive subjects between 18 and 82 years of age. Bilateral tear...

A prospective, multisite clinical study (10 sites in the European Union and the United States) evaluated the clinical utility of commonly used tests and tear osmolarity for assessing dry eye disease severity. Three hundred fourteen consecutive subjects between the ages of 18 and 82 years were recruited from the general patient population, 299 of wh...

Purpose: (1) To investigate the relationship between dry eye symptoms and lipid layer thickness (LLT) in patients presenting for routine eye examination and (2) to consider the practicality of interferometry in a clinical practice. Methods: Patients presenting consecutively for routine eye examinations were recruited (n = 137, age range = 18-60 yea...

(1) To investigate the relationship between dry eye symptoms and lipid layer thickness (LLT) in patients presenting for routine eye examination and (2) to consider the practicality of interferometry in a clinical practice. Patients presenting consecutively for routine eye examinations were recruited (n = 137, age range = 18-60 years, mean = 41.7 +/...

ABSTRACT Like dry eye disease 15 years ago, blepharitis today is a poorly defined condition about which there is considerable misunderstanding. For a variety of reasons, there is little good data on either the prevalence of blepharitis or how eyecare practitioners currently treat it. The work reported herein consists of two recent studies: a teleph...

Ocular allergic conditions and contact lens wear affect a large percentage of the population; the implications for interaction of allergy and changes induced by contact lens wear are significant. In addition, contact lenses are used in the treatment of severe forms of ocular allergic disease. The major themes of this review are the effects of conta...

To present evidence from the literature and scientific meetings to support fundamental changes in concepts regarding the prevalence, pathogenesis, definition, diagnosis, management of dry eye disease (DED) and the prospects for the development of new therapies. Analysis and clinical perspective of the literature and recent presentations. Review and...

The management of dry eye disease (DED) encompasses both pharmacologic and nonpharmacologic approaches, including avoidance of exacerbating factors, eyelid hygiene, tear supplementation, tear retention, tear stimulation, and anti-inflammatory agents. Artificial tears are the mainstay of DED therapy but, although they improve symptoms and objective...

This article discusses the use of contact lenses in patients suffering from dry eye and ocular allergy. The diagnosis of dry eye is outlined along with the relationship between contact lenses, the tear film, and the ocular surface. A practical approach to the recognition and management of the dry eye patient wishing to wear contact lenses is presen...

To provide an overview of considerations in the design and performance of prospective clinical trials in the evaluation of new pharmaceutical and surgical treatments in dry eye disease (DED). A compilation and interpretation of experiences in the challenges and pitfalls of clinical trial design based on experiences documented in the peerreviewed li...

Purpose: The members of the Management and Therapy Subcommittee assessed current dry eye therapies. Methods: Each member wrote a succinct level of evidence‐based review on an assigned aspect of the topic, and the final report was written after review by and with consensus of all subcommittee members and the entire DEWS membership. In addition to it...

The aim of the DEWs Definition and Classification Subcommittee was to provide a contemporary definition of dry eye disease, supported within a comprehensive classification framework. A new definition of dry eye was developed to reflect current understanding of the disease, and the committee recommended a three-part classification system. The first...

The members of the Management and Therapy Subcommittee assessed current dry eye therapies. Each member wrote a succinct evidence-based review on an assigned aspect of the topic, and the final report was written after review by and with consensus of all subcommittee members and the entire Dry Eye WorkShop membership. In addition to Its own review of...

ABSTRACT we have developed and evaluated the repeatability of a short questionnaire based on a visual analog scale (VAS) to quantify the frequency and severity of symptoms of dry eye syndrome (DES). The "Symptom Assessment iN Dry Eye" (SANDE) questionnaire utilizes a 100 mm horizontal VAS technique to quantify patient symptoms of ocular dryness and...

This text is a welcome volume on the newly emerging surgical technology of conductive keratoplasty. The principal authors of this book are experienced refractive surgeons who have been in the forefront in developing this promising technology. They have assembled an outstanding group of refractive surgical leaders who share the experience and techni...

To develop current treatment recommendations for dry eye disease from consensus of expert advice. Of 25 preselected international specialists on dry eye, 17 agreed to participate in a modified, 2-round Delphi panel approach. Based on available literature and standards of care, a survey was presented to each panelist. A two-thirds majority was used...

In consideration of the patient presenting with symptoms of tearing, it might seem incongruous to add tear defi ciency to a list of diagnostic possibilities. This is, however, an important aspect that must be considered in view of the prevalence of dry eye and the fact that some patients with dry eye can present with subjective symptoms simulating...

Contact lenses should be used with caution in patients who have an ocular allergy. Patients who have seasonal allergy should avoid contact lens use during seasonal flare-ups. The need for clean lenses with minimal deposit buildup must be stressed, and the use of daily wear lenses with rigid disinfecting and cleaning techniques is recommended. Alter...

“What’s New in Surgery” evolves from the contributions of leaders in each of the fields of surgery. In every instance the author has been designated by the appropriate Council from the American College of Surgeons’ Advisory Councils for the Surgical Specialties. This feature is now presented in issues of the Journal throughout the year.

Objective To evaluate the safety and efficacy of the removal of INTACS.

To evaluate the 2-year effects of intrastromal corneal ring segments (INTACS) on the corneal endothelium. Non-contact specular microscopy was performed as a subgroup test in a Phase III clinical trial. Endothelial cell images were collected before surgery and at 6, 12, and 24 months after surgery at the central and peripheral (6 and 10 o'clock) reg...

Patients with S ogren's syndrome (SS) have a high incidence of immune mediated ocular inflammation, making them more susceptible to infectious agents. However, the more common manifestation seen in patients with SS is immune mediated noninfectious inflammation of the lacrimal glands and ocular surface, resulting in decreased tear production and inf...

To review developments in dry-eye research leading to new therapeutic possibilities and to suggest a prioritizing schema. New development in our understanding of the pathogenesis, diagnoses, and treatment of dry-eye states have been reviewed along with the possible impact on new therapeutic approaches. A variety of approaches to the pathogenesis an...

We conducted a 3-month, randomized, comparative cross-over study to evaluate the clinical performance of lenses manufactured from omafilcon A on subjects with signs and symptoms of dry eye. The subjects' own daily wear soft lenses were used as controls. Seventy-six subjects with objective evidence of dry eye, as defined in the NEI/Industry Workshop...

Dry eye, or keratoconjunctivitis sicca (KCS), is a rubric for a number of clinical disease states characterized by disturbances in the pre-ocular tear film resulting in ocular surface disease.1 KCS accounts for a high percentage of patient visits to ophthalmologists, and its treatment has given rise to a pharmaceutical market in the US of over $100...

We developed a Dry Eye Screening Questionnaire for the Dry Eye Epidemiology Projects (DEEP), a proposed large epidemiologic study. All persons who screen positive and a small sample of those who screen negative are to be invited for a diagnostic examination. Containing 19 questions, of which only 14 were used in the analysis, the questionnaire take...

Purpose. To evaluate the safety of the ICRS™ (Intrastromal Corneal Ring Segments) for the correction of myopia. Methods. The frequency of each ocular observation/complication noted for patients participating in the U.S. Phase II trial of the ICRS was calculated. Each finding was then categorized by its relative clinical significance, according to p...

Blepharitis is probably the most common disease entity seen in the general ophthalmologist's office. A significant proportion of these cases are secondary to meibomian gland disease. This review outlines our knowledge of the histopathology, lipid abnormalities and role of microorganisms in meibomian gland dysfunction. We will also review the physio...

Purpose: Cyclosporin A (CsA) is an immune modulator which prevents T cell-mediated immune-reactivity. The efficacy of a 1% topical ophthalmic CsA preparation compared to placebo was evaluated in SS patients whose KCS was inadequately controlled by conventional treatment. Methods: Thirty-three SS patients with KCS were enrolled into this double-mask...

The evaluation of treatments in medicine has progressed at an accelerated pace in the last half century. No development has been more central to this progress than the advent of the randomized controlled clinical trial. Sir Austin Bradford Hill, who was the father of this scientific genre was judged by the President of the Royal College of Physicia...

Contributions to the literature concerning physiology of the lacrimal glands, production of tears, structure and function of the tear film, dry-eye states, the effects of eye drops, and toxic effects on the external eye have continued to extend our knowledge concerning these important processes. In recent years, the intimate association between the...

We examined the morphology of the corneal surface epithelial cells in 13 eyes of 13 subjects using specular microscopy. We determined cell area, perimeter, and shape comparing the central cornea with the inferior and superior periphery. We found surface epithelial cells are significantly smaller in the central cornea. The cells measured 560 +/- 93...

We used specular microscopy of the corneal epithelium to examine 29 eyes of 29 patients each wearing one of five different types of contact lenses. We compared these with 24 eyes of 24 age-matched control patients. We found patients with aphakic extended wear soft contact lenses had significantly larger cells (818 +/- 186 microns2) than all other g...

Using the tandem scanning microscope, in vivo confocal microscopic images of living eyes were compared to images obtained from ex vivo, freshly enucleated or fixed tissue in the rabbit. In the normal cornea, microscopic details of the superficial epithelium, basal lamina, stromal fibrocyte nuclei, nerves and endothelial cell borders were easily dis...

A flexible system for the real-time acquisition of in vivo images has been developed. Images are generated using a tandem scanning confocal microscope interfaced to a low-light-level camera. The video signal from the camera is digitized and stored using a Gould image processing system with a real-time digital disk (RTDD). The RTDD can store up to 3...