Cataract extraction with multifocal intraocular lens implantation: clinical, functional, and quality-of-life outcomes. Multicenter clinical trial in Germany and Austria.

PURPOSE: To compare bilateral implantation of a multifocal intraocular lens (IOL) versus a monofocal lens with respect to visual function, patient satisfaction, and quality of life. SETTING: Seven clinical sites in Germany and 1 site in Austria. METHODS: A prospective randomized masked clinical trial included 124 randomly assigned bilateral pseudophakic individuals, 64 of whom had bilateral implantation of an Array(R) foldable multifocal IOL (model SA-40N, Allergan) and 60 of whom had bilateral implantation of an AMO(R)PhacoFlex II(R) silicone monofocal IOL (model SI-40NB). Clinical data included binocular uncorrected and corrected distance and near visual acuities, complications, adverse events, and reports of halos and glare. Quality-of-life data were collected on 3 occasions using the modified Cataract TyPE Specification instrument. The functional status of the 2 groups was compared from baseline to final postoperative interview. RESULTS: Three months after surgery, a higher proportion in the Array group achieved a Jaeger value of J3 (20/40 Snellen) or better uncorrected binocular near visual acuity and 0.5 (20/40) or better distance-corrected binocular near visual acuity than in the monofocal groups (97% versus 68% and 95% versus 59%, respectively; P <.001). A higher proportion in the multifocal group achieved both 0.5 (20/40) and J3 or better uncorrected binocular distance and near visual acuities (97% versus 66%; P <.001). Those in the Array group were more likely than those in the monofocal group to never wear glasses overall (41% versus 12%; P <.001). Multifocal patients rated their vision without glasses better overall, at near and at intermediate distances (P <.05), and demonstrated better visual function for near tasks and social activities. CONCLUSIONS: Those who had bilateral implantation of the Array multifocal IOL obtained better uncorrected and distance-corrected near visual acuities and reported better overall vision, less limitation in visual function, and less spectacle dependency than patients with bilateral monofocal IOLs.

[The COMOD system. A preservative-free multidose container for eyedrops]. / Das COMOD-System. Ein konservierungsmittelfreies Mehrdosenbehältnis für Augentropfen.

BACKGROUND: The newly developed COMOD -system is a multi-dose-container for eye drops which makes the addition of preservatives unnecessary. In this study we investigated the microbiological safety of the COMOD -system which was used in action for the first time. METHODS: After cataract surgery 97 patients only used unpreserved, dexamethason-containing eye drops in COMOD -bottles for two days in hospital and for five more days at home. The used bottle were examined microbiologically afterwards. RESULTS: No COMOD -bottle showed a microbiologically serious contamination; no patient showed an unusual healing process which would have been typical for any infection. Concerning the handling it turned out during use in hospital that the hand-made prototypes have to be improves. The vast majority of patients managed the handling at home well, independent of sex or age. CONCLUSION: The COMOD -system is a suitable microbiologically safe container for unpreserved eye drops.

[Visual acuity at twilight and contrast vision in patients with bifocal IOL]. / Dämmerungssehschärfe und Kontrastsehvermögen bei Trägern von Bifocal-IOL.

After cataract extraction by phacoemulsification, the True Vista bifocal lens (group I; Storz Ophthalmics, St. Louis, Missouri, USA) was implanted in 20 eyes, and the Accurasee bifocal lens (group II; Alcon, Forth Worth, Texas, USA) was implanted in 14 eyes. Following a 4-6 month postoperative period, both groups were checked with respect to visual acuity, mesopic acuity, and thresholds of contrast under mesopic light conditions. As mean values, group I demonstrated a distance acuity without correction of 0.77 (+/- 0.17), group II of 0.73 (+/- 0.14); the average near acuity without correction in group I was 0.84 (+/- 0.17), and in group II, 0.85 (+/- 0.15). The near acuity, with distance correction only, was determined to be 0.94 (+/- 0.09) in group I, and 0.91 (+/- 0.01) in group II. Examination of mesopic visual acuity by means of the Mesoptometer II (Oculus Company, Dutenhofen) revealed 0.25 (+/- 0.08) for the True Vista bifocal lens, and 0.26 (+/- 0.07) for the Accurasee bifocal lens. Under reduced field luminance, both groups of lenses showed comparable results while testing contrast thresholds were under 0.1 cd/m2; under 0.032 cd/m2 and 0.1 cd/m2 with permanent glare, however, group I demonstrated a slight advantage.

Scanning electron microscopic and energy-dispersive X-ray analysis findings on two brand new intraocular lenses.

Two intraocular lenses (IOLs) from the same manufacturer showed surface particles by scanning electron microscopy. With energy-dispersive X-ray analysis, these were shown to contain Mg-Si, Al-Mg-Si, Ti, Fe, Ca and Cu. A sterile chronic intraocular inflammation may result from implantation of such contaminated IOLs.

[Hemodynamic findings in patients with retinitis pigmentosa]. / Hämodynamische Befunde bei Patienten mit Retinitis pigmentosa.

The hemodynamic status of 26 patients with retinitis pigmentosa was examined using video fluorescein angiography. The hemorheological parameters hematocrit, plasma viscosity, erythrocyte aggregation and erythrocyte rigidity were determined. The results were compared to a matched pairs-group. Video angiography showed for retinitis pigmentosa patients a normal arm-retina time and a significant increase of the arteriovenous passage time. The rheological parameters for both groups were within the reference range. Interestingly the hemodynamic disturbance of microcirculation could be demonstrated already in early stages with no ophthalmoscopic symptoms and no atrophy of retinal vessels detectable at the time. The results indicate that disturbance of the retinal hemodynamics in early stages of retinitis pigmentosa may play a role in the pathogenesis of the disease.

[Silver nitrate burn after Credé's preventive treatment. A roentgen analytic and scanning electron microscopy study]. / Silbernitratverätzung nach Credéscher Prophylaxe. Eine röntgenanalytische und rasterelektronenmikroskopische Untersuchung.

Following Credé's prophylaxis with silver-nitrate, the cornea of a newborn presented greyish-brown, lime-like plaques on the nasal part of the right eye. A paracentral ulcerating stromal opacification undermined these appositions, when the patient was admitted to the eye-clinic at Aachen. In the material taken in a lamellar keratectomy scanning electron microscopical examination was able to prove the existence of granules, previously described in light-microscopy. These granules measured 100 to 300 nm in diameter and were placed up to 110 microns deep into the corneal stroma of the specimen. An earlier chemical analysis of necrotic material showed no silver specific reaction. By means of EDX-Analysis these granules could be identified as silver-containing. This was once reassured by a newly developed modification of van-Kossa's-staining-method. The fact that the granular deposits contained mainly silver proves that the onset of a sodium-chloride-irrigation did not promote an intended therapeutic silver-chloride-precipitation and therefore had no effects on the silver-nitrate's penetration abilities. Injuries by silver-nitrate-solutions used for Credé's prophylaxis are seldom but still reported. The mechanism of injury in this case of a child, born by sectio remains unknown. Neither the use of an unusual silvernitrate solution, that was taken from a disposable ampoule (Mova-Nitrat) was reported, nor any corneal injury during sectio mentioned.(ABSTRACT TRUNCATED AT 250 WORDS)

[Hemodilution in patients with central retinal vein thrombosis. A placebo-controlled randomized study]. / Hmodilution bei Patienten mit Zentralvenenthrombose der Retina. Eine plazebokontrollierte randomisierte Studie.

A randomized placebo-controlled study was conducted in 40 patients with acute retinal vein occlusion, 19 of whom received iso-(Hct greater than or equal to 42%) or hypervolemic (Hct less than 42%) hemodilution over 10 days with daily infusion of 250 ml hydroxyethyl-starch (MW 200,000/0.5, 10% HAES-steril) in combination with pentoxifylline (oral: 1200 mg/day; i.v.: 300 mg/day; Trental). After this 10-day trial of hemodilution rheological therapy was continued with pentoxifylline (oral: 1200 mg/day; Trental). The control group of 21 patients received no hemodilution or rheological therapy. After 10 days 35 patients underwent laser coagulation. Clinical, hemodynamic and rheological data of all patients were recorded before therapy, after 10 days but before laser coagulation, and after 6 weeks. In the group treated with hydroxyethyl-starch in combination with pentoxifylline, 10 patients had an improvement of central vision by two or more lines after 6 weeks. In the control group only 4 patients showed central vision improved by two or more lines after 6 weeks. In the treated group the retinal circulation and rheological data were significantly improved after 10 days of hemodilution therapy.

Results with multichannel topographical bipolar recordings of the visual evoked potential in normals and amblyopes.

The method currently used to record topographical voltage distributions of visual evoked potentials is that of monopolar recording with respect to some arbitrary reference electrode. As an alternative we investigated the method of bipolar topographical recording of the checkerboard reversal evoked potential in four amblyopic patients and ten normal persons. The recordings were performed with a system of 14 bipolar channels, arranged in a rectangular grid with an interelectrode distance of 15% of the inion-nasion distance and centered 3 cm above the inion. The gradient distributions of the visual evoked potential obtained from normal persons showed at the time of component P2 a maximum about 3 cm above the inion. The healthy eyes of the amblyopic patients showed similar distributions and latencies. The amblyopic eyes showed normal or reduced amplitudes and normal or increased latencies with large checks and low amplitudes with smaller checks. The topographical distributions recorded with the bipolar recording system showed shifts of the maxima with the larger patterns in three of four amblyopic eyes. A technical comparison showed that these shifts can be recorded by the bipolar recording method with higher accuracy than with the monopolar method, promising a better understanding and more accurate diagnosis of amblyopia.

Corneal silver deposits following Crede's prophylaxis an examination with electron dispersive x-ray analysis (EDX-analysis) and scanning electron microscope (SEM).

In a case of silver nitrate injury after Credé's prophylaxis, the cornea of a newborn presented yellow-brown, lime-like plaques on the nasal part of the right eye. A paracentral ulcerating stromal opacification undermined these appositions, when the patient was admitted to the eye-clinic at Aachen. In the material obtained by a lamellar keratectomy scanning electron microscopical examination was able to prove the existence of granules, previously described in light-microscopy. These granules measured 100 to 300 nm in diameter. An earlier chemical analysis of necrotic material showed no silver specific reaction. By means of EDX-analysis these granules could be identified as silver-containing. Injuries by silver nitrate solutions used for Credé's prophylaxis are seldom but still reported. The mechanism of injury in this case of a child, born by sectio remains unknown. Neither the use of an unusual silver nitrate solution, that was taken from a disposable ampoule (Mova-Nitrat R) was reported, nor any corneal injury during sectio mentioned. Nevertheless the method of EDX-analysis and SEM proved the diagnosis of corneal silver deposits, so that the origin of the granullar opacification of the cornea could be determined.

Retinal and retinocortical times to pattern stimulation in amblyopic children.

In order to determine whether in amblyopes retinal conduction delays contribute to the cortical measureable delays in the visual evoked cortical potential (VECP), peak latencies of the pattern electroretinogram (ERG) are measured in amblyopic children. The results are compared with those of the normal fellow eyes and those of a healthy control group. Simultaneously the latencies in the VECP are recorded and the determination of the retinocortical times is performed. Statistically retinal b-wave (Q) and a-wave (P) of the pattern ERG of amblyopic eyes do not show significant delays of peak latency. In retincortical times, however, there are significant prolongations. During occlusion therapy retinocortical values of normal fellow eyes are also delayed in comparison with the control group. A pathological conduction delay of visual information on the retinal level up to the generators of the pattern ERG can thus be excluded in amblyopia. The total latency delay in the VECP of amblyopes consists solely in a prolongation of retinocortical times.

[Use of the scanning laser ophthalmoscope for recording pattern electroretinography and visual evoked cortical potentials]. / Anwendung des Scanning Laser-Ophthalmoskops zur Registrierung des Muster-Erg und Vecp.

With a scanning laser ophthalmoscope (SLO) variable patterned stimuli can be projected onto the retina. During alternation of these patterns visual evoked cortical potentials and pattern ERGs can be recorded. The configurations of the SLO-elicited potentials and peak latencies correspond to those evoked during conventional stimulation. During pattern stimulation the fundus and alternating pattern stimuli are observed simultaneously on a video monitor. Thus the examiner always knows the exact location of the stimulus on the retina. Scanning laser ophthalmoscopy could be a clinically interesting method of recording evoked potentials, because it enables the patient's retina to be viewed continuously at low light levels and makes electrophysiological examination of a defined region of the retina possible.

Surgical procedures in the treatment of most severe eye burns. Revival of the artificial epithelium.

Report of some clinical observations in 16 patients with severe and most severe burns of 19 eyes. Major problems were delayed regeneration of the epithelium, extensive ulceration of the sclera near the limbus, and subsequent corneal ulceration. The therapy with anti-inflammatory drugs, macromolecular hyaluronic acid, fibronectin, epidermal growth factor, free transplants of oral mucosa and conjunctiva was sometimes helpful, but could not induce stable epithelial regeneration. The major problem remained the inability of the epithelium to regenerate on the cornea. Therefore, an artificial epithelium was applied in many cases. When healthy conjunctiva touched closely the artificial epithelium at the limbus, it remained tightly attached to the corneal stroma, preserved it's structure and even prevented corneal vascularisation for many months. However, when corneo-scleral ulceration was present, the artificial epithelium failed to protect the corneal stroma from secondary ulceration and sloughed off. Therefore, new surgical procedures, a conjunctiva-Tenon flap and a Tenon plasty were introduced to cover and to cure corneoscleral ulceration. These operations formed a new limbus, attached tightly to the rim of the artificial epithelium and prevented secondary ulceration underneath. Then under the protection of the artificial epithelium and the Tenon plasty the eye could be treated topically with corticosteroids for a long time. When the inflammatory response to the burn was healed, the natural epithelium recovered and the eye became ready for successful keratoplasty.

[The development of stereoscopic vision in the first months of life]. / Vision stéréoscopique: étude objective et développement pendant les premiers mois de la vie.

Dynamic random dot patterns generated on a TV screen by a special pattern generator are proven to be adequate stimuli for testing stereopsis. The registration of transient visual evoked cortical potentials (VECP) to these random dot stimuli offers objective proof of stereopsis. Using different disparities in older people a typical amplitude behaviour in the dynamic random dot stereo VECP with maximum amplitudes to medium sized disparities was found. Compared to 20 adults and 30 children with normal vision, in 26 children with negative TNO- and Titmus-tests for stereoscopic vision treated for strabismus no dynamic random dot stereo VECPs could be recorded. The development of stereoscopic vision in the first 12 months of life was investigated in five babies. First positive components in the dynamic random dot stereo VECP could be found in the 4th to 6th months of life in all children. From these results the assumption, that stereoscopic vision develops in later childhood, must be revised in favour of a much earlier period of infancy.

[Retinal hemodynamics and morphologic findings in patients with occlusion of the internal carotid artery]. / Retinale Hämodynamik und morphologische Befunde bei Patienten mit Verschluss der Arteria carotis interna.

Only a minor percentage of patients with occlusion of the internal carotid artery develops the clinical symptoms of ischemic ophthalmopathy. The degree of functional collateralization that mirrors the alteration in ocular perfusion seems to be of importance for its development. We employed video fluorescein angiography to determine the degree of minor retinal perfusion in 33 patients. With a picture analyzer (Microvideomat 3, Zeiss) we quantified the arm-retina time (ART), the arteriovenous passage time (AVP) and the arterial dye bolus velocity. In these patients retinal perfusion was significantly decreased compared to a normal control group. The AVP of 18 patients was more than triple the average normal value (1.45 +/- 4.0 s); 3 of these patients showed morphological signs of ischemic ophthalmopathy with extensive non-perfusion areas: they showed a change in retinal hemodynamics and a massive deficiency in vasomotor response to CO2 stimulation. After panretinal laser coagulation their retinal hemodynamics, morphological alterations and subjective complaints improved. Our results show that using video fluorescein angiography on patients suffering from occlusion of the internal carotic artery analyzing the retinal hemodynamics can help to determine whether ischemic ophthalmopathy is developing or not.

[Tenonplasty as a new surgical principle in the early treatment of the most severe chemical eye burns]. / Die Tenonplastik als neues Operationsprinzip in der Frühbehandlung schwerster Verätzungen.

A special danger in cases of severe chemical and thermal eye burns is the development of corneoscleral ulceration. To treat these most severe burns tenonplasty was developed as a new surgical treatment. The principle of tenonplasty is based on a plastic operation in which vital connective tissue of the orbit is used. First, all necrotic tissue is removed from the conjunctiva and sclera. The Tenon tissue is then bluntly separated from the equatorial region of the globe and from extraocular muscles. It is important to keep its blood vessels intact and to prepare the Tenon sheet with a smooth surface, because regenerating conjunctival epithelium has to slide on this layer. After preparation, the elastic Tenon flap can be moved to the limbus and sutured tightly to the sclera, thus providing a revascularization of the denuded sclera and the limbus region. In all patients the scleral ulceration healed and the eyes were saved from anterior segment necrosis. Although rapid regeneration of conjunctival epithelium on the Tenon layer always occurred rapidly, the cornea was completely covered by new epithelium in only a few cases: an artificial epithelium was therefore applied early in most patients. After tenonplasty and application of an artificial epithelium high local doses of corticosteroids can be given to suppress reactive inflammation and prevent neovascularization of the cornea.

[Video fluorescence angiography follow-up of patients with retinal stasis syndrome]. / Videofluoreszenzangiographische Verlaufsbeobachtungen bei Patienten mit retinalem Stase-Syndrom.

Forty-four patients were examined by video-fluorescein angiography. With the onset of the first symptoms a significant decrease in retinal blood flow was determined by prolonged arteriovenous passage time (AVP) and diminution of mean dye bolus velocity (MDV). No correlation could be found between the extent of impeded retinal perfusion in the acute phase and the severity of the clinical appearance. In 35 of the 44 patients a favorable clinical course was observed. An initially markedly reduced retinal perfusion improved under treatment by isovolemic or hypervolemic hemodilution, fibrinolysis, and panretinal laser coagulation, and remained stationary during the further course of time. Complete normalization of the AVP and the MDV could not be found in any of these patients. Sixteen percent of the patients with retinal stasis syndrome developed hemorrhagic central venous thrombosis. In the authors' opinion videoangiographic follow-up of patients with retinal stasis syndrome is essential for early detection of further-reduced retinal perfusion. It may thus be possible to prevent the transition to hemorrhagic central retinal vein occlusion in these cases by early treatment.

Evidence of pericentral stereopsis in random dot VECP.

Dynamic random dot patterns generated on a TV screen by a special pattern generator are proven to be adequate stimuli for testing stereopsis. In our experimental set-up we use red-green coded striped or checkered patterns of various size and disparity as stimuli, which are viewed through red-green glasses (anaglyph method). The registration of transient visual evoked cortical potential (VECP) to these random dot stimuli offers objective proof of stereopsis. There is a typical amplitude behavior with maximum amplitudes at medium disparities. By recording the specific stereo VECP while masking the central retinal areas stepwise (artificial central scotoma) we can objectively show intact stereopsis of corresponding pericentral retinal areas. This peripheral stereopsis is demonstrable in the VECP by central scotomas up to eight degrees.

[Biomicroscopy of an intraocular lens. Comparison of specular microscopy findings with the cytologic specimen]. / Biomikroskopie einer Intraokularlinse. Vergleich des spiegelmikroskopischen Befundes mit dem zytologischen Präparat.

Seventeen months after implanting an anterior chamber intraocular lens the lens had to be removed because of secondary glaucoma and retinal hemorrhage. The lens had been examined 5 days prior to surgery. It appeared that histiocytic giant cells and fibroblasts had settled on its surface. This was subsequently confirmed by cytological studies. It therefore appears possible to describe an in vivo differential cytology and to diagnose the type of inflammatory reaction in vivo.