Iodized polyvidone (betadine) and prevention of postoperative infection. A multicenter study]

A multicentre study of a new preparation of povidone iodine (5% betadine) was carried out on 150 patients undergoing cataract surgery. Pre-operatively the eye was prepared by daubing the peri-ocular skin and a two-minute instillation into the conjunctival fornices. No other antiseptic was applied. Tolerance to the product was evaluated in all the patients: clinical evaluation postoperatively and during a 60-day follow-up period confirmed that the preparation was harmless to the eye. Microbiological investigations (comprising conjunctival swabbing, bacterial culture and count of the bacterial species isolated, before and after application of the product) performed on 60 patients showed a significant fall in the number of colonies after treatment.     

Use of cyclosporin A eyedrops in the prevention of corneal graft rejection in man. I. Preoperative development of 4 eyes with metaherpetic keratitis

Topical cyclosporine A (2%) has been used to prevent corneal graft rejection in high risk patients. The treatment was begun 48 h at least before surgery. 3 patients (4 eyes) suffering from metaherpetic keratitis were placed under this treatment for a long time due to the delay to obtain a corneal donor. Their observation while treated showed a remarkable slow-down of the inflammation both in conjunctivae and corneas. This confirms if necessary the role of T lymphocytes in metaherpetic corneal diseases and the clinical modulation effect of cyclosporine A on these T cells.     

Comparative multicenter study of carteolol eyedrops with other beta blockers in 768 patients under normal conditions

In an open multi-center study involving 768 patients the efficacy and tolerability of Carteolol eye drops as compared to other beta blockers were investigated. The patients started to use the new medication without a prior washout period. In patients who were well stabilized (57%), IOP either did not change when the medication was switched to Carteolol (73%) or it actually decreased. In 78% of the patients who had not responded altogether satisfactorily to the pretreatment, Carteolol eye drops lowered IOP to a tolerable level of 21 mm Hg or less without using any comedication. IOP remained hypertonic under Carteolol in only 19% of the cases. Fewer systemic and local side effects were observed under Carteolol therapy. Patients had fewer problems going upstairs. Burning after installation decreased by 25% to 2%. Even fluorescein-positive corneal findings almost completely disappeared under Carteolol.     

Incidence of allergy to eyedrops. Results of a prospective survey in a hospital milieu

An estimation of the frequency of allergic contact reactions to eyedrops was obtained by means of a prospective study on hospitalized patients. The incidence of cases with a positive patch test was 6% during hospital care. The drugs blamed were atropine (allergic contact reaction in 3% of treated patients), phenylephrine (risk 2.6%) and neomycin (risk 1.7%). The preservatives were not involved in any case. More than half of the patients had a previous history of eyedrop contact allergy, but they only rarely knew which drug was involved. The systematic use of patch tests to identify the allergenic drug(s), the accurate information of the patient and the parcimonious use of allergenic drugs, particularly of antibiotic eyedrops, are simple measures which should decrease notably the incidence of allergic contact reactions.     

A multicenter randomized study of fusidic acid ophthalmic gel and rifamycine eyedrops in acute conjunctivitis

A total of 163 patients with acute, presumably bacterial, conjunctivitis were included in a randomized trial, comparing: 1% fusidic acid viscous eye drops, a new ophthalmic formulation of fusidic acid instilled twice daily with rifamycin eye drops, four times daily. Both drugs were given 7 days long. Bacterial origin of the conjunctivitis, mainly staphylococcal, was proved in 75% of the cases. Overall, at the end of the treatment, a satisfactory response, on bacteriological and clinical grounds, was recorded for 87.3 and 89.5% of the patients in the Fucidin gel and rifamycin groups respectively. 9 and 12% of the patients in each group respectively, had a clinical recurrence 15 days after the treatment. No significant difference between the groups clinically and bacteriologically was noted. Side effects, mainly burning and smarting were noted by the investigators in 8 and 11 patients treated by fusilic acid and rifamycin respectively. Two patients were taken out of the study in the rifamycin group because of allergy. The difference between the groups is not significant. The use of fusidic acid viscous eye drops as compared to rifamycin eye drops was judged significantly easier by the patients (P less than 0.02), especially because of the reduced number of applications, the lack of color, and the lase of application.     

Brolucizumab-related intraocular inflammation in Japanese patients with age-related macular degeneration: a short-term multicenter study

Graefe's Archive for Clinical and Experimental Ophthalmology -     

Clinical tolerance of antiglaucoma eyedrops with and without a preservative. Results of an unpublished survey in Europe]

PURPOSE: To evaluate the clinical tolerance of antiglaucoma eye drops with and without a preservative in routine practice. METHODS: A total of 125 ophthalmologists in private practice located throughout France examined altogether 919 glaucomatous patients treated with eye drops containing a preservative or not. For some patients the examination was repeated during a second visit. Functional signs as well as conjunctival and corneal examination results were recorded. RESULTS: The proportion of patients experiencing discomfort or pain during instillation was 58% for eye drops containing a preservative and 30% for eye drops with no preservative (p < 0.001). Moreover, the proportion of patients presenting at least one symptom of eye irritation (sensation of itching or burning, sensation of a foreign body in the eye, and flow of tears) was greater with preservative-containing eye drops (53% vs 34%; p < 0.001). The experience of discomfort during instillation was more often associated with problems later on. The patient's complaints were correlated with objective signs of conjunctival (conjunctival redness, conjunctival follicles), or corneal (superficial punctuate keratitis) damages. A higher proportion of patients treated with eye drops containing a preservative showed at least one conjunctival sign (52% vs 35%; p = 0.001) or superficial punctuate keratitis (12% vs 4%; p = 0.01). In 164 patients, whose treatment was changed from eye drops containing a preservative to eye drops with no preservative and who were examined a second time (mean interval between visits: 3.3 months) the frequency of all symptoms and objective signs fell by a factor of 3 to 4 (p < 0.001). CONCLUSION: Patient complaints and objective damage to the ocular surface are more frequent among patients treated with eye drops containing a preservative. Ocular surface damage due to preservatives is partially reversible. Patient complaints should consequently be taken into account and preservative-free eye drops should be prescribed when ever possible.     

Subjective photic phenomena with refractive multifocal and monofocal intraocular lenses. results of a multicenter questionnaire

PURPOSE: To compare the incidence and severity of photic phenomena after the implantation of the Array(R) (Allergan) refractive multifocal intraocular lens (MIOL) and a monofocal IOL. SETTING: Multicenter study at Kiel, Mainz, Karlsruhe, and Bremerhaven, Germany. METHODS: The study comprised 231 randomly selected patients from 4 study centers. The patients had had uneventful phacoemulsification with implantation of a refractive MIOL (n = 138) or a monofocal IOL (n = 93). By questionnaire, patients were asked whether they experienced light sensations postoperatively (light streaks, halos, flare, flashes, or glare) that had not been noticed preoperatively. Additional questions evaluated whether these phenomena had changed over time and how much they affected the patients' quality of life. RESULTS: Overall, 9% of patients with a monofocal IOL and 41% of those with an MIOL reported photic phenomena that had not been noticed before cataract surgery. Halos and flare were mentioned significantly more often by patients with MIOLs than by those with monofocal IOLs. There was no significant between-group difference in the mention of flashes. Eighteen percent of patients with MIOLs and 4% with monofocal IOLs were slightly or moderately bothered by the photic phenomena, whereas 5% of patients with MIOLs and none in the monofocal group were severely disturbed by the light sensations. CONCLUSION: Subjective photic phenomena were experienced significantly more often by patients who had refractive MIOLs than by those who had monofocal IOLs. The differences in the results of the 4 study centers were probably influenced by different patient selection criteria for the implantation of MIOLs.     

The TRUE-VISTA bifocal IOL. Results of the European multicenter study]

In the last few years a number of bifocal IOL has been developed. The True Vista IOL, a three-zone refractive bifocal IOL with central and peripheral distance zones and a pericentral near annulus, was implanted in 367 patients in a prospective European multicenter study between February 1990 and May 1991. Visual acuity, pupil size and astigmatism were determined. At 4-6 months near acuity was measured with reading charts (Nieden Chart) and at 7-11 months with a Snellen chart (Lighthouse Chart). At 4-6 (7-11) months, so far 164 (73) of the patients have been available for follow-up. Best corrected distance acuity was 20/40 or better in 97% (99%), best corrected near acuity was 20/30 or better in 91% (83%), and uncorrected near acuity was 20/30 or better in 64% (59%). Average Snellen near acuity (Lighthouse Chart) was 20/25, slightly lower than the average reading acuity of 20/22 (Nieden Chart) (p = 0.34, Wilcoxontest). Distance and near acuity also decreased with increasing astigmatism and increasing age. Our results demonstrate good visual acuities with the True Vista bifocal IOL. Age and postoperative astigmatism may affect the performance of bifocal IOL. Snellen near acuity is reduced, despite normal reading acuity, but further investigation is required.     

双氯芬酸钠滴眼剂在白内障手术前后的应用

本文在白内障患眼手术前后应用国内研制的0.1%双氯芬酸钠滴眼剂(40例),同时用生理盐水设置对照组(30例),结果表明此药可以有效地防止术中瞳孔缩小及减轻术后的炎症反应,与对照组比较差异有显著性.且未发现严重毒副作用.     

Artisan phakic intraocular lens for myopia:short-term results of a prospective,multicenter study

PURPOSE: To evaluate the safety and efficiency of the Artisan iris-supported phakic intraocular lens (Ophtec BV, Groningen, Netherlands) for the correction of high myopia. STUDY DESIGN: Nonrandomized, prospective, multicenter trial conducted under a United States Food and Drug Administration (FDA) Investigational Device Exemption. PARTICIPANTS: One hundred fifty-five eyes of 155 patients with myopia from -5.5 to -22.5 diopters (D) underwent implantation of an Artisan lens, as part of a phase I, II, or III FDA trial. METHODS: Eyes were examined at 1 day (154 eyes), 2 weeks (142 eyes), 2 months (130 eyes), and 6 months (84 eyes). Intraocular pressure and presence of flare and cell on slit-lamp biomicroscopy were recorded at each visit. MAIN OUTCOME MEASURES: Achieved correction, stability of spherical equivalent refraction, change in astigmatism, postoperative uncorrected vision, change in best spectacle-corrected acuity, and change in endothelial cell count. RESULTS: Mean spherical equivalent manifest refraction stabilized on postoperative day 1. Mean difference between attempted and achieved correction at 2 months was -0.32 +/- 0.95 D (mean +/- standard deviation; range, -4.42 to +2.2 D). At 6 months, 85% of eyes saw 20/40 or better uncorrected, and 90% of eyes were within 1 D of the attempted correction. Refractive astigmatism increased in 4.8% of eyes and decreased in 17% of eyes at 6 months. At 2 months, six eyes (4.8%) lost two or more lines of best spectacle-corrected visual acuity; by 6 months, no eyes lost two or more lines of best-corrected visual acuity. Endothelial cell count was unchanged at 6 months compared with the preoperative count. Nonprogressive lens opacities developed in four eyes as a result of surgical trauma. Chronic inflammation was not detected in any eye by slit-lamp biomicroscopy, nor did any eye develop angle closure or glaucoma. CONCLUSIONS: Short-term results suggest that the Artisan lens is an accurate and safe method for the correction of high myopia. Surgical skill is important in avoiding lens opacities. Longer-term data are needed to assess the impact of the lens on the endothelium, the crystalline lens, and the iris.     

Preoperative disinfection of the conjunctival sac with antibiotics and iodine compounds: A prospective randomized multicenter study

Purpose  To compare disinfection by povidone-iodine (PI) solution with that by polyvinyl alcohol-iodine (PAI) solution in preoperative eyewash and to assess the optimal duration of the preoperative application of 0.5% levofloxacin (LVFX) ophthalmic solution. Methods  Two-hundred-seventy-two elderly cataract patients who had undergone phacoemulsification aspiration with intraocular lens insertion at 12 clinical facilities in Japan were randomized into three groups: 3-day, 1-day, and 1-h preoperative application of 0.5% LVFX ophthalmic solution. Each LVFX group was further divided into two subgroups; the patients in one subgroup were treated with diluted PI eyewash, and those in the second subgroup with diluted PAI eyewash, immediately before the surgery. Thus, a total of six groups were studied. Conjunctival scrapings were collected four times: before LVFX application, after LVFX application, after the eyewash with iodine compounds, and after the surgery. Samples of the aqueous humor were collected immediately after the surgery. All samples were cultured aerobically and anaerobically. Results  The 3-day application of LVFX had a significantly higher disinfection rate than the 1-day or 1-h applications (P < 0.05). The disinfection rate of PI was 78.0%, and that of PAI was 79.4%; PAI was not inferior to PI as a preoperative disinfectant. However, new isolates, mainly Propionibacterium acnes and Staphylococcus epidermidis, were detected after LVFX application and even after use of the eyewash with iodine compounds. Conclusion  Three-day administration of LVFX ophthalmic solution and use of an eyewash with diluted iodine compounds is effective for preoperative disinfection. However, complete elimination of bacteria from the conjunctival sac is difficult. A complete list of the members of the Preoperative Disinfection Study Group follows the Acknowledgments.     

Complications with foldable intraocular lenses with subsequent explantation in 1998 and 1999. Results of a questionnaire evaluation

Purpose. A questionnaire was sent to all members of the German Society of Ophthalmic Surgeons to evaluate complications of foldable intraocular lenses (IOLs) that required explantation. Methods. Information on preoperative visual acuity, foldable IOL design and material as well as the reason for IOL explantation was obtained and analysed. We received 167 completed questionnaires for 1998 and 1999. Results. In 1998 and 1999 the most common reasons for IOL explantation were as follows: incorrect lens power for 56% of the 3-piece hydrophobic acrylic IOLs, 16% because of glare or other photic phenomena, 40% of the 1-piece hydrophilic acrylic IOLs were explanted because of incorrect lens power and 30% for IOL damage. For the 3-piece monofocal silicone IOLs, 41% were explanted because of incorrect IOL power and 32% because of IOL decentration. For the 1-piece Hydrogel IOL, 76% were explanted because of opacification of the optic and 14% because of incorrect lens power. Most multifocal IOLs were explanted because of photic phenomena. Conclusion. In addition to the most common complications such as decentration and incorrect IOL power observed in rigid IOLs, new complications associated with foldable IOLs occurred such as optic opacification, glare and photic phenomena. Some complications seemed to appear in particular IOL types (opacification: SC-60BOUV, MDR), while others were observed in all types of foldable lenses. Accurate calculation of the IOL power and further improvement of the IOL material and design seem to be necessary to minimise the rate of explantations.     

Results with a modified method for scleral suturing of intraocular lenses

PURPOSE / METHODS: The long-term results obtained by a modified method of scleral suturing of posterior chamber lenses (PCLs) (Behndig & Otto 1997) were retrospectively registered and evaluated. Forty-four patients with insufficient capsular support for ordinary PCL implantation were included. Mean follow-up time was 13.1 +/- 6.4 months and registered parameters included visual acuity, deviation from planned refractive outcome, induced astigmatism, and complications. RESULTS / CONCLUSIONS: The results were comparable to those reported earlier for this type of surgery. It has previously been stated that scleral suturing of posterior chamber lenses is a safe procedure with good long-term results. This modified method produces comparable results while being more surgically simple and reproducible.     

Efficacy of cimetidine/pyrilamine eyedrops. A dose response study with histamine challenge

Eighteen healthy volunteers participated in a histamine challenge, dose response study of cimetidine (H2 antagonist)/pyrilamine (H1 antagonist) eyedrops. This was a randomized, double-masked, multiple-crossover trial, consisting of six visits spaced 48 hours apart. At each visit, subjects were pretreated with one of six different doses of test medication in one randomly selected eye and with vehicle in the fellow eye. Five minutes later, one drop of 0.0075% histamine was instilled in both eyes. Conjunctival hyperemia and edema were graded at various time points during a 20-minute interval after the instillation of histamine. Results indicated that the cimetidine/pyrilamine combination was effective in preventing histamine-induced conjunctival hyperemia in normal volunteers; neither cimetidine nor pyrilamine was effective when administered alone.     

White-noise field campimetry before and after artificial increase of intraocular pressure. Possible applications in diagnosis and evaluation of glaucoma]

A total of 173 eyes (visual field defect stages O-V) of 99 glaucoma patients were investigated by means of conventional threshold-oriented suprathreshold automated test point perimetry using the Tübingen Automatic Perimeter (TAP) and by means of white-noise-field campimetry (flickering random dot pattern) using the Tübingen Electronic Campimeter (TEC). Most eyes were affected by primary open-angle glaucoma (119) or low tension glaucoma (35). The concordance between the two methods was good in 65 eyes (37.6%). Sufficient in 32 (18.5%) eyes, poor in 32 cases (18.5%) and inadequate in 44 eyes (25.4%). Among the last group of 44 eyes, 32 perceived a scotoma in the noise field (NF) but did not show any pathologic defect in conventional automated test point perimetry: the opposite constellation was found in only 12 eyes. In most cases, scotoma in the NF showed a change in both brightness and motion (noise) perception. No clear relationship between the type of glaucoma and a certain constellation of the aforementioned NF specifications could be found. Complete lack of noise perception in the scotoma occurred more frequently in advanced glaucoma (stage > or = IV). In 110 eyes of 63 of the glaucoma patients, white-noise-field campimetry was carried out during artificial IOP elevation achieved by suction-cup oculopression: during steplike increases of the negative pressure in the suction-cup up to maximum of 375 mmHg the following stages could be seen (the percentage of eyes that perceived each phenomena over the negative pressure range is shown in brackets): change in NF perception compared with initial findings (96.4%); impairment of central noise-field perception (78.2%); concentric constriction of NF (61.8%); complete breakdown of noise (field) perception (42.7%). A further, quantitative classification of these eyes was possible by evaluation of the negative pressure in the suction-cup that led to any one of these NF phenomena. The results demonstrate the usefulness of white-noise-field campimetry as a very fast screening method for detecting glaucomatous visual field defects. It can also be performed as a pressure tolerance test and thus be used to classify glaucomatous risk stages.