A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma

Purpose To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG). Design Prospective, multicenter, randomized, single-masked, controlled clinical trial. Participants One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg. Methods On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Wa…

Substanzen für Viskoelastika

Hyaluronat (Abb. 26) kommt in nahezu allen Bindegeweben von Vertebraten vor und besteht aus einem verhaltnismasig langen linearen Polysaccharidmolekul (Balsasz et al., 1970). Es wird in der Zellmembran ohne Proteinbeteiligung synthetisiert und die lange lineare Polysaccharidkette wird direkt in die extrazellulare Matrix extrudiert (Prehm, 1984). Natriumhyaluronat dient der Zell- und Gewebsstabilisierung und spielt eine wichtige Rolle wahrend der embryonalen Entwicklung und des Wachstums. Auf Zellebene spielt Natriumhyaluronat bei der interzellularen Interaktion, Zellmatrixadhasion, Zellmobilitat und der extrazellularen Organisation eine gewisse Rolle. Weiterhin wird die Wundheilung beschleu…

Keratopathie als Zeichen einer multifokalen kongenitalen sensiblen Polyneuropathie

Patient. Bei einer 63-jahrigen Patientin bestanden seit 10 Jahren beidseits rezidivierende korneale Ulzera mit Trubungen, Vaskularisation und aufgehobener Sensibilitat. Daneben fanden sich asymmetrisch angeordnete hypasthetische Areale. Sensible Nervenaktionspotenziale der betroffenen Regionen waren nicht ableitbar, sensorisch evozierte Potenziale fielen pathologisch aus, Muskeleigenreflexe waren ausgefallen. In der Suralisbiopsie zeigte sich ein hochgradiger Mangel an markhaltigen Axonen. Erworbene Polyneuropathieformen konnten ausgeschlossen werden. Therapie. Nach konservativen Therapieversuchen erfolgte wegen der vaskularisierten Hornhautnarbe eine perforierende Keratoplastik am linken A…

Viscoelastics: Medical Device or Drug

In § 2 of the German Drug Laws (AMG, Arzneimittelgesetz), it is determined that such materials that fall under the heading of medicinal products (MPG, Medizinproduktegesetz, 1994) are not drugs in the AMG sense of the word. MPG medicinal products, as defined in §3 are those substances whose main effect is neither pharmacological, immunological, nor metabolic.

Real-time control for transscleral cyclophotocoagulation.

• Background: In transscleral cyclophotocoagulation, the surgeon cannot directly observe the applied laser effects. Overdosage, possibly resulting in unwanted pop effects, or underdosage with no therapeutic effect therefore often occur. • Method and materials: Laser radiation passing through the sclera and ciliary body is partly reflected from the fundus and can be monitored from outside the eye by a detector system. Since all other parameters influencing the intensity of the recorded radiation are constant in time during one laser exposure, the time dependence of this radiation directly reflects the change of transmission of the treated tissue. The laser exposure therefore can be stopped b…

Allgemeine Einsatzmöglichkeiten von Viskoelastika

Die vielfaltigen physikochemischen Eigenschaften der viskoelastischen Substanzen bedingen ihre wunschenswerten und unerwunschten Eigenschaften beim klinischen Einsatz. Da es fur alle klinischen Belange keine ideale Substanz gibt, empfiehlt es sich, die verschiedenen Charakteristika fur die jeweilige Anforderung zu berucksichtigen. Georg Eisner beschrieb viskoelastische Substanzen als ein Werkzeug fur raumtaktische Masnahmen (Gewebstaktik, Raumtaktik und Oberflachentaktik) mit speziellen Techniken (Eisner, 1980; Eisner, 1983). Beim chirurgischen Einsatz dienen Viskoelastika dem Schutz von Gewebe und Zellen vor einem mechanischen Trauma, zur Aufteilung von Gewebe, zum Schaffen von Raum, zur L…

Spezielle Einsatzmöglichkeiten von Viskoelastika

Healon®5: A New Viscoadaptive Formulation

To relate the practical relevance of our study results, specific requirement profiles for individual procedures have been correlated to the desired physicochemical characteristics. Healon®5 demonstrated the statistically significant highest zero shear viscosity of all OVD and a long relaxation time (Dick et al., 2000). It therefore most effectively creates and maintains a deep anterior chamber in order to facilitate safe surgical maneuvers (e.g., in case of vitreous pressure). Additionally, the high viscosity of Healon®5 exhibits a dynamic frequency dependence, which has not been observed in any pure hyaluronic acid formulation before. Healon®5’s properties change in response to surgical ma…

Diskussion unter Berücksichtigung der eigenen Ergebnisse

Die Rasterelektronenmikroskopie ist bestens geeignet als Methode zur Beurteilung von Oberflachenstrukturen. In der Ophthalmochirurgie wurde sie erstmals von Drews et al. (1978), spater von Dersch (1981) eingesetzt, um Inhomogenitaten in der Oberflachenbeschaffenheit von Intraokularlinsen nachzuweisen, ferner wurde mikrochirurgisches Operationsinstrumentarium im Rahmen der Qualitatskontrolle rasterelektronenmikroskopisch untersucht (Adams, 1991; Thornton, 1991; Eisenmann und Jacobi 1993b).

Postoperative astigmatism and rotational stability after Artisan toric phakic intraocular lens implantation

Abstract Purpose To evaluate deviations in the axis (intended versus achieved) and postoperative astigmatism after implantation of an Artisan toric phakic intraocular lens (IOL). Setting University Eye Hospital, Mainz, Germany. Methods This prospective study comprised 29 eyes with high ametropia and astigmatism. All eyes had uneventful implantation of a toric phakic IOL through a superior scleral tunnel incision at 12 o’clock. After a minimum of 6 months, the uncorrected visual acuity (UCVA), best correct visual acuity, refraction, and astigmatism were analyzed in all eyes. A multivariate analysis of postoperative astigmatism was performed. Results After a follow-up of at least 6 months, 95…

Complications Through the Use of Viscoelastics

Viscoelastic material retained behind the IOL may cause a capsular bag distension in the early postoperative period. These eyes accumulate a transparent substance in the closed chamber inside the capsular bag from the IOL blocking the capsular opening. The capsular bag distension was first discribed by Davison in 1990. Miyake et al. proposed a new classification of capsular block syndrome and supposed viscoelastic material to cause early-postoperative capsular block syndrome (Miyake et al., 1999). Capsular bag distension after optic capture of a sulcus-fixated IOL was described by Basti et al. (1999).

Aseptic Production vs. Terminal Sterilization

The safety of substance use in intraocular surgery ideally requires the absence of all biologically-active components capable of causing an inflammatory reaction. Substance purity is achieved with isolation and cleansing methods (e.g., of the polysaccharide), which remove any biological component with infective potential. The methods of production for polysaccharide isolation should remove biological agents, regardless of its origin. Hyaluronic acid is isolated either from rooster combs or biological fermentation. Use of this substance showed the development of postoperative intraocular inflammatory reactions resulting from contaminations from both sources. OVD should have low endotoxin val…

Transpalpebral tonometry: reliability and comparison with Goldmann applanation tonometry and palpation in healthy volunteers

Background/aim: TGDc-01 is a new, portable, transpalpebral tonometry device. The aim of this study was to evaluate the reproducibility of this method, including intraobserver and interobserver deviations, and to compare the results with those of Goldmann applanation tonometry and palpation of intraocular pressure (IOP). Methods: A total of 40 eyes of 20 healthy volunteers were included. Two independent parallel observers (1 and 2) performed three replicate measurements per eye, respectively, both using TGDc01 tonometry, one observer (3) performed three replicate measurements using Goldmann applanation tonometry, and one observer (4) measured the IOP via palpation. Intraindividual deviations…

Effect of large positioning holes on capsule fixation of plate-haptic intraocular lenses

Abstract Purpose To compare the centration and fixation of silicone plate-haptic intraocular lenses (IOLs) with different-sized positioning holes. Setting Eye Clinic of the Johannes Gutenberg-University Mainz, Mainz, Germany. Methods In a prospective randomized study, 51 Chiroflex C10 and 56 Chiroflex C11 IOLs were implanted under standardized conditions by the same surgeon. The IOL position was documented at the end of surgery and by retroillumination on the first day and 5 months postoperatively. The positioning-hole area was evaluated by ultrasound biomicroscopy (50 MHz) 5 months postoperatively. Results One day postoperatively, no IOL in either group was decentered more than 1.0 mm. Aft…

Healon5 versus Viscoat during cataract surgery: intraocular pressure, laser flare and corneal changes

Background: The use of a viscoelastic substance facilitates cataract surgery. Healon 5 is a new viscoelastic product with special rheological properties. We evaluated the postoperative effect of Viscoat and Healon5 on intraocular pressure (IOP), central corneal thickness (CCT), endothelial cell counts and laser flare. Methods: Forty-eight eyes of 48 patients undergoing routine phacoemulsification followed by foldable IOL implantation were enrolled. Either Healon5 or Viscoat was used according to a block- randomization scheme. The aspiration technique was standardized. IOP, CCT, endothelial cell counts and laser flare were compared pre- and postoperatively. Statistical analysis was performed…

Komplikationen nach Molteno-Implantat: Eine Falldarstellung

We present a 43-year old patient with refractory secondary glaucoma, who showed epithelial downgrowth into the anterior chamber following Molteno implant surgery. It will be discussed, whether the Molteno implant or the following keratoplasty, which was necessary because of corneal decompensation, caused the epithelial downgrowth.

Toric phakic intraocular lens

Abstract Objective To evaluate safety, efficacy, predictability, stability, complications, and patient satisfaction after implantation of Artisan toric phakic intraocular lenses (TPIOLs) for the correction of myopia or hyperopia with astigmatism. Design Prospective, nonrandomized, comparative (self-controlled) multicenter trial. Participants Seventy eyes of 53 patients (mean, 35 years; range, 22–59 years) with preoperative spherical equivalent between +6.50 and −21.25 diopters (D) and cylinder between 1.50 and 7.25 D. Methods Seventy eyes underwent implantation of a TPIOL with an optical zone of 5.0 mm (Artisan, Ophtec, Groningen, The Netherlands). The dioptric power of the intraocular lens…

Special Uses of Viscoelastics

The possibilities of viscoelastic use in phacoemulsification will be outlined in the following figures. Many ophthalmic surgeons apply viscoelastic substances in capsulorhexis to achieve a deep anterior chamber and extend the pupillary space (with a small pupil). Care must be taken during injection so that aqueous is permitted to flow out. When using a paracentesis to inject viscoelastic (Fig. 59), it must be big enough to allow aqueous outflow. For complete aqueous exchange in the anterior chamber, it is advisable to inject the viscoelastic into the opposite chamber angle.

Übereinstimmung von klinischer Beurteilung, Heidelberg-Retina-Tomograph (HRT) und Nerve Fiber Analyzer (GDx) in der Glaukomdiagnostik

BACKGROUND We have made a comparison of clinical evaluation, Heidelberg-Retina-Tomograph (HRT) and Nerve Fiber Analyzer (GDx) in diagnosing glaucoma. MATERIALS AND METHODS One eye of 38 glaucoma patients and 26 non-glaucoma patients was examined with HRT and GDx. Assignment of the patients into the two groups by clinical evaluation was performed on the basis of visual field and optic disc results. As classification criterion for glaucoma/non-glaucoma by means of the instruments we employed the statistical classification of the HRT and "the number" of the GDx. Statistical analysis was performed with Cohen's kappa and McNemar tests. Additionally, ROC curves for evaluation of the sensitivity a…

Komplikationen durch Anwendung der Viskoelastika

Komplikationen durch Viskoelastika entstehen entweder durch unsachgemase Injektion (z. B. Uberfullung) oder durch unzureichende Entfernung.

Spezielle operative Aspekte der Kleinschnitt-Kataraktchirurgie bei Implantation multifokaler IOL

Der hohe Standard und die Sicherheit bei der Entfernung der Linse und Implantation der Intraokularlinse mit weitestgehender Perfektionierung der Techniken ruckt die Bedeutung im Umgang mit dem vorbestehenden Astigmatismus in den Vordergrund des Interesses. Im Rahmen der praoperativen Vorbereitung ist also auch die Erfassung des Astigmatismus und die danach ausgerichtete Wahl der entsprechenden Operationstechnik zur Erlangung des gewunschten postoperativen Astigmatismus wichtig. Hierbei lassen sich grob schematisch in Abhangigkeit vom praoperativen Astigmatismus, verschiedene Ziele unterscheiden: korneale Spharizitat zu erhalten, masigen Astigmatismus geringfugig und hohen Astigmatismus deut…

Intraocular pressure after small incision cataract surgery: temporal sclerocorneal versus clear corneal incision.

To compare intraocular pressure (IOP) after phacoemulsification and foldable intraocular lens (IOL) implantation using a temporal sclerocorneal or clear corneal incision.Department of Ophthalmology, Johannes Gutenberg-University, Mainz, Germany.One hundred patients (100 eyes) with cataract having phacoemulsification with posterior chamber IOL implantation were randomly assigned to receive a temporal sclerocorneal or clear corneal tunnel incision. Intraocular pressure was measured preoperatively and 6 hours, 1, 2, and 3 days, and 5 months postoperatively. Statistical significance was determined by nonparametric group comparisons using 2-sample random Wilcoxon tests.Six hours postoperatively,…

Absaugung des Viskoelastikums

Bei allen Viskoelastika empfiehlt sich die vollstandige Entfernung aus dem Auge, um beispielsweise die Wahrscheinlichkeit eines mitunter deutlichen Anstiegs des Augeninnendrucks zu verringern. Verbleibt Viskoelastikum hinter der IOL, kann es eine Refraktionsanderung bewirken. Bei unzureichender Entfernung kann eine hoch molekulare viskose Substanz nur verzogert aus dem Auge uber das Trabekelmaschenwerk abtransportiert werden mit der Folge eines hohen und moglicherweise protrahierten postoperativen Augenin-nendruckanstiegs.

Refraktion, Vorderkammertiefe, Dezentrierung und Tilt nach Implantation monofokaler und multifokaler Silikonlinsen

Hintergrund. Ziel der prospektiven Studie war die Analyse von Refraktion, Vorderkammertiefe, Dezentrierung und Verkippung (Tilt) nach Implantation monofokaler (MONO) und multifokaler (MIOL) Intraokularlinsen (IOL). Patienten und Methode. Bei 103 Augen von 103 Patienten wurde entweder eine dreistuckige monofokale oder multifokale Silikon-IOL implantiert. Vorderkammertiefe (ACD), IOL-Dezentrierung und -Tilt wurden mittels Retroilluminationsfotografie und Scheimpflug-Aufnahmen objektiv quantifiziert. Die Untersuchungen einschlieslich Ermittlung der sujektiven Refraktion wurden praoperativ sowie postoperativ nach 1 Woche und nach 6 Monaten vorgenommen. Ergebnisse. Im Bereich von ±1 dpt um die Z…

Trabeculotomy in congenital glaucoma.

Background: Congenital glaucoma is a potentially blinding disease that requires surgical therapy. This paper describes the outcome of trabeculotomy in primary congenital glaucoma. Methods: Thirty-nine eyes of 22 children with congenital glaucoma who underwent trabeculotomy with or without a simultaneous trabeculectomy between 1992 and 1997 were retrospectively analyzed. Results: Mean follow-up was 24.7±17.9 months. A mean of 1.3 operations per eye were performed. The mean IOP at the end of follow-up (n=39) was 17.7±6.0 mmHg; in 8 eyes (20.5%) the IOP was >21 mmHg, in 31 eyes (79.5%) it was ≤21 mmHg. The mean difference between pretreatment IOP and IOP at the end of follow-up (n=39) was –10.…

Fallzahlplanung bei ophthalmologischen Studien*

An essential aspect in the cooperation of clinic and biometry consists in designing of studies, e.g. during the preparation of grant applications or for review by official drug surveillance institutions. A central aspect in study planning is the design-adequate and well-documented prediction of sample size, which should be recommended for any intended study. Based on several examples for sample size planning in study designs, which are of common relevance for ophthalmology, guidelines are derived to enable clinical researchers to perform sample size planning on their own. The latter can be based on the various available software packages for sample size prediction.

Implantation of the modified endocapsular bending ring in pediatric cataract surgery using a viscoadaptive viscoelastic agent.

Cataract surgery and intraocular lens (IOL) implantation in pediatric eyes remain controversial. Using a viscoadaptive viscoelastic agent, we implanted a modified capsular bending ring (CBR) as well as an acrylic IOL with a sharp-optic-edge design in the capsular bag. All operated eyes demonstrated a low postoperative inflammatory reaction and a clinically well-centered IOL. The band-shaped, sharp-edged CBR facilitates the creation of a sharp, discontinuous bend in the equatorial capsule, which prevents anterior and posterior capsule opacification. Combining the viscoadaptive viscoelastic agent and the CBR enhances the safety of primary and secondary posterior chamber IOL implantation in pe…

Sutureless ciliary sulcus supported intraocular lens with transiridal anchoring haptics.

We report a technique for implanting intraocular lenses (IOLs) in the ciliary sulcus in eyes without capsule support. The IOL design allows it to be implanted without fixation sutures. The lens was implanted in 3 aphakic eyes without capsule support.

General Applications of Viscoelastics

The many and diverse physicochemical characteristics of viscoelastic substances impose both their desired and undesired effects clinically. As there is no single ideal substance to meet clinical stipulations, individual viscoelastic characteristics should be considered with respect to demand. Georg Eisner described viscoelastic agents as a tool for space-occupying measures (in tissues, in space or on surfaces) applied by the use of special techniques (Eisner, 1980; Eisner, 1983). In surgery, viscoelastic substances protect tissues and cells from mechanical trauma, serve to separate tissues, occupy space, break away adhesions, stop bleeding, coat, act as manipulative instruments and move tis…

Effects of Early Postfiltration Ocular Hypotony on Visual Acuity, Long-term Intraocular Pressure Control, and Posterior Segment Morphology

Purpose To determine whether hypotony after filtration surgery has any influence on visual acuity and intraocular pressure (IOP) lowering. Patients and methods We prospectively investigated 43 eyes of 43 patients undergoing trabeculectomy without the use of antimetabolites for 12 months. Results The lowest postoperative IOP valued 4.9 +/- 3.6 mm Hg (range, 0-14 mm Hg). It correlated statistically significant with the IOP 6 weeks (P = 0.016), 6 months (P = 0.009), and 1 year after surgery (P = 0.027). Eyes with a deterioration of visual acuity 6 weeks after surgery had undergone a stronger postoperative hypotony (correlation with lowest postoperative IOP, P = 0.035). The mean period with an …

Removal of Viscoelastic Substances

All viscoelastics should be completely removed from the eye to reduce the likelihood of increased intraocular pressure. Should OVD retention behind the IOL occur, an unstable refraction could result. Residual high molecular viscous substance is transported away through the trabecular meshwork, with delay, possibly resulting in a protracted postoperative IOP increase. To aspirate viscoelastics various techniques as well as instruments with different aspiration/irrigation adjustments have been proposed, a few of which will be described here. Viscoelastic removal involving the simultaneous irrigation and aspiration through a single cannula (Nevyas, 1987) or two separate cannulas (Brauweiler, 1…

Ocular pulse amplitude in patients with open angle glaucoma, normal tension glaucoma, and ocular hypertension.

Intraocular pressure (IOP) is not a fixed constant value but rather has pulsatile components associated with cardiac action. The SmartLens dynamic observing tonometer (odc, Ophthalmic Development Company AG, Zurich, Switzerland) can measure and record simultaneously IOP and ocular pulse amplitude (OPA). It was the aim of this study to evaluate OPA in patients with primary open angle glaucoma (POAG) and high IOP, normal tension glaucoma (NTG), and ocular hypertension (OHT). Furthermore, the authors examined whether there were any correlations with blood pressure.80 subjects were divided into four groups (n=20): 20 patients each with POAG, NTG, and OHT and 20 volunteers without any ocular pat…

Objective and subjective evaluation of photic phenomena after monofocal and multifocal intraocular lens implantation11The authors have no commercial or financial interest in any aspect of this study.

Abstract Objective To objectively measure and compare halo, flicker, and glare disability in pseudophakic eyes with monofocal (MONO) and multifocal (MULTI) intraocular lenses (IOLs) with respect to the influence of corneal surface quality, astigmatism, and age. Design Prospective case series. Participants This clinical trial involved 28 eyes of 28 patients after small-incision cataract surgery with a MONO silicone IOL and 28 eyes of 28 patients with zonal-progressive silicone IOL. Intervention A computer program objectively determined halo, glare, and flicker. Corneal surface quality and astigmatism were measured using computerized videokeratography. Ray-tracing analysis was performed based…

Aseptische Herstellung versus terminale Sterilisation

Die Sicherheit einer Substanz fur die intraokulare Chirurgie erfordert idealerweise die Abwesenheit aller biologisch aktiven Komponenten, die eine Entzundungsreaktion hervorrufen konnen. Die Reinheit einer Substanz wird dann erzielt, wenn eine Methode zur Isolation und Reinigung z. B. des Polysaccharids angewendet wird, die jede biologische Komponente mit entzundungserzeugendem Potential entfernt. Die Herstellungsmethoden zur Isolation des Polysaccharids mussen in der Lage sein, biologisch aktive Agentien unabhangig von deren Herkunft zu entfernen. Hyaluronsaure wird entweder aus Hahnenkammen oder nach biologischer Fermentation isoliert. Nach Einsatz von Hyaluronsaure sowohl aus Hahnenkamme…

Patientenselektion für MIOL

Trotz der beschriebenen ausgezeichneten klinischen Ergebnisse der untersuchten MIOL sollte bei deren Implantation eine Reihe spezifischer Ein- und Ausschluskriterien beachtet werden. Auch wenn wir im Laufe der Zeit die Indikation zur Implantation von MIOL — insbesondere von MIOL des Typs Array (Jacobi und Eisenmann, 1995) — immer groszugiger stellten, so konnen diese die monofokale IOL sicherlich nicht generell ersetzen.

Komplikationen einer großen kongenitalen Ziliarkörperzyste

Background Multiple cysts of iris and ciliary body may cause many complications such as acute or chronic angle closure glaucoma. Patient We present a boy with multiple congenital cysts of the iris pigment epithelium and a voluminous cyst of the unpigmented ciliary body epithelium of the right eye. This resulted in lenticular astigmatism, concomitant strabismus divergens and subsequently to anisometropia. The voluminous cyst (8 x 12 mm in diameter) was folded around the lens, reached the optic axis and resulted in displacement of the lens and contact between the iris and the corneal endothelium from 6.30 to 11. After puncture and partial resection of the cyst at the age of 8 months the boy d…

Contrast sensitivity and glare disability by halogen light after monofocal and multifocal lens implantation

BACKGROUND—Standard examination of contrast sensitivity under conditions of glare disability is performed with incandescent light. A new halogen glare test that simulates glare as seen with oncoming vehicle headlights was used to measure glare disability in patients implanted with multifocal and monofocal intraocular lenses (IOLs). METHODS—28 patients with an average age of 69 years (SD 12 years) were implanted with a monofocal IOL (SI-40NB, Allergan) and 28 patients with an average of 66 years (12 years) were implanted with a refractive multifocal IOL (Array-SA-40N, Allergan). All patients were followed for 5 months postoperatively. Contrast sensitivity at four spatial frequencies (3, 6, 1…

Ionising radiation and lens opacities in interventional physicians: results of a German pilot study

We assessed the feasibility of an epidemiological study on the risk of radiation-related lens opacities among interventional physicians in Germany. In a regional multi-centre pilot study associated with a European project, we tested the recruitment strategy, a European questionnaire on work history for the latter dosimetry calculation and the endpoint assessment. 263 interventional physicians and 129 non-exposed colleagues were invited. Questionnaires assessed eligibility criteria, risk factors for cataract, and work history relating to occupational exposure to ionising radiation, including details on type and amount of procedures performed, radiation sources, and use of protective equipmen…

Inflammation after sclerocorneal versus clear corneal tunnel phacoemulsification.

Abstract Objective To compare the postoperative inflammation after phacoemulsification followed by intraocular lens (IOL) implantation by means of sclerocorneal versus clear corneal tunnel incision. Design Randomized controlled clinical trial. Participants One hundred eyes of 100 patients were examined at a German University eye hospital. Intervention One hundred eyes with cataract necessitating phacoemulsification with posterior chamber IOL implantation were randomly assigned to receive a temporal sclerocorneal or clear corneal tunnel incision by a single surgeon. Main outcome measures Preoperative and postoperative inflammation was evaluated by measurement of flare using laser flare photo…

Effects of intraocular cefotaxime on the human corneal endothelium

Abstract Purpose To ascertain whether 0.4 mL of cefotaxime 0.25% applied intracamerally causes toxic alteration of the human corneal endothelium. Methods In this prospective randomized masked study, 66 patients had cataract extraction using phacoemulsification, a frown incision, and implantation of a poly(methyl methacrylate) intraocular lens. This was followed by intraocular injection of 0.4 mL of cefotaxime 0.25% or balanced salt solution (BSS®). Contact specular microscopy and photography were performed preoperatively and 1 to 4 days and 3 months postoperatively. Results In the cefotaxime group, the mean endothelial cell count was 2729 cells/mm 2 ± 474 (SD) preoperatively, 2520 ± 462 cel…

Viskoelastika: Medizinprodukt oder Arzneimittel?

In § 2 Abs. 3 Ziff. 7 Arzneimittelgesetz (AMG) ist geregelt, das solche Stoffe, die dem Medizinproduktegesetz (MPG, 1994) unterfallen, nicht Arzneimittel im Sinne des AMG sind. Als Medizinprodukte werden in § 3 Abs. 1 MPG Stoffe definiert, deren bestimmungsgemase Hauptwirkung weder auf pharmakologischem oder immunologischem Gebiet liegt noch durch Metabolismus erzielt wird.