Impact of personality characteristics on patient satisfaction after multifocal intraocular lens implantation: results from the "happy patient study".

PURPOSE: This prospective multicenter study assessed personality characteristics that may influence patient satisfaction after implantation of multifocal intraocular lenses (MIOLs). METHODS: One hundred eighty-three patients who underwent bilateral implantation of different MIOLs were enrolled. Uncorrected and corrected distance visual acuity for distance and near (ie, UDVA, UNVA, CDVA, and CNVA) were assessed preoperatively and 3 and 6 months after implantation. Before surgery, personality characteristics were evaluated using a questionnaire based on the NEO Personality Inventory Test and the Compulsiveness Inventory Test. At the 3- and 6-month postoperative visits, patients answered a questionnaire concerning overall satisfaction, need for spectacles at different distances, visual function at different distances and lighting conditions, photic phenomena, and ease of performing daily activities. RESULTS: Three months after surgery (n = 163), mean CDVA was 0.03 ± 0.09 logMAR, UDVA was 0.05 ± 0.09 logMAR, and UNVA was 0.04 ± 0.11 logMAR. At the 6-month visit (n = 131), mean CDVA was 0.02 ± 0.07 logMAR, UDVA was 0.06 ± 0.09 logMAR, and UNVA was 0.05 ± 0.01 logMAR. Most patients (82.2%) would opt for an MIOL again, 3.7% would not, and 14.1% were uncertain. Overall satisfaction with the procedure was correlated to low astigmatism, good visual function, low spectacle dependence, and less halos or glare. The personality characteristics of compulsive checking, orderliness, competence, and dutifulness were statistically significantly correlated to subjective disturbance by glare and halos. CONCLUSIONS: Postoperative patient satisfaction after MIOL implantation is correlated to visual performance, spectacle independence, and less photic phenomena. Personality characteristics have an impact on subjective disturbance by photic phenomena and thus are important for patient satisfaction.

Tilt and decentration of an intraocular lens implanted in the ciliary sulcus after capsular bag defect during cataract surgery.

PURPOSE: To determine the impact of ciliary sulcus implantation after capsular bag defect on tilt and decentration of foldable intraocular lenses (IOL) measured by a novel device. METHODS: This prospective noncomparative single-center investigation included patients (N = 10) older than age 60 who underwent cataract surgery with a posterior capsular bag defect and implantation of a threepiece hydrophilic aberration neutral IOL (OphthalmoPro AC 7013) in the ciliary sulcus. All eyes (N = 10) were examined using the OPD-Scan II (Nidek). Spherical aberration (Z4,0), vertical coma (Z3,-1), and horizontal coma (Z3,1) were calculated for a 5.0 mm pupil. Lens tilt and decentration was studied using a new Purkinjemeter. RESULTS: The mean horizontal optic tilt was 7.68° ± 5.16 (SD) and the mean vertical optic tilt was 3.01° ± 2.44 (SD). Horizontal decentration was 0.4 ± 0.33 mm (SD) and vertical decentration was 0.31 ± 0.21 mm (SD). Corneal aberrations were partially compensated by IOL- related aberrations. CONCLUSIONS: Both tilt and decentration of sulcus-fixated IOLs exceeded the tolerable amounts evaluated for aspheric IOLs in eye model experiments. However, these spheric IOLs showed mitigation rather than accentuation of corneal wavefront aberrations in the rare event of capsular bag defect during cataract surgery.

Decentration and tilt of a single-piece aspheric intraocular lens compared with the lens position in young phakic eyes.

PURPOSE: To compare the tilt and decentration of a single-piece aspheric intraocular lens (IOL) and the position of the natural crystalline lens in young individuals. SETTING: Department of Ophthalmology, Knappschafts Hospital, Sulzbach, Germany. METHODS: This prospective noncomparative single-center study included volunteers younger than 40 years with no ocular abnormalities (crystalline lens group) and patients older than age 62 who had uneventful cataract surgery and Tecnis ZCB00 IOL implantation (IOL group). All eyes were examined with the OPD-Scan II; spherical aberration, vertical coma Z(3,-1), and horizontal coma Z(3,1) were analyzed with a 5.0 mm pupil. Lens tilt and decentration were studied with a new Purkinje meter. RESULTS: The crystalline lens group and IOL group comprised 20 subjects (40 eyes) each. Both groups showed compensation for corneal spherical aberration and neutralization of horizontal corneal coma. All lenses were tilted upward (mean 2.2 degrees, crystalline lens; 2.5 degrees, IOL) and to the temporal side (mean 3.1 degrees, crystalline lens; 2.6 degrees, IOL). The crystalline lenses were decentered downward (mean 0.16 mm) and to the temporal side (mean 0.07 mm). The IOL was displaced to the nasal side of the pupil (mean 0.06 mm) with almost no vertical mean decentration (0.02 mm upward). CONCLUSIONS: The aspheric IOL and young crystalline lens compensated for mean corneal spherical aberration, resulting in low total spherical aberration. The position of the IOLs showed minimal decentration and tilt and was mirror symmetrical, comparable to the position of the crystalline lens in young individuals. The slight malpositioning partially compensated for corneal horizontal coma.

Comparison of the AcrySof IQ aspheric blue light filter and the AcrySof SA60AT intraocular lenses.

PURPOSE: The development of aspheric intraocular lenses (IOL) designed to compensate for the positive spherical aberration of the cornea has been shown to improve the image quality of pseudophakic eyes. This prospective clinical study compared an aspheric IOL with a blue light filter (AcrySof IQ) with its spherical platform--the SA60AT IOL with conventional optic. METHODS: After uneventful phacoemulsification, 42 and 20 eyes were implanted with the AcrySof IQ aspheric lens and the SA60AT, respectively. Six weeks after surgery, higher order aberrations, visual acuity, contrast sensitivity, depth of focus, pupil size, and corneal asphericity were assessed. RESULTS: Visual acuity was good with both IOLs. A significant difference was found regarding spherical aberration. Mean values of spherical aberration, calculated for a 5-mm pupil were 0.20 +/- 0.06 microm with the SA60AT and 0.04 +/- 0.05 microm with the AcrySof IQ lens. Contrast sensitivity was significantly superior in the AcrySof IQ group in 7 of 15 measurement conditions. Asphericity of the cornea proved to be correlated with postoperative ocular spherical aberration. CONCLUSIONS: The aspheric optic design of the AcrySof IQ results in significant reduction of postoperative ocular spherical aberration and improved contrast vision. Measuring the corneal asphericity allows estimation of postoperative ocular spherical aberration.

Intraindividual comparison of the effect of training on visual performance with ReSTOR and Tecnis diffractive multifocal IOLs.

PURPOSE: Several studies have shown that after multifocal intraocular lens (IOL) implantation visual function improves gradually over a period of several months. To accelerate this learning process, a prospective, intraindividual comparative study was performed to investigate the efficacy of a special visual training program on the postoperative visual performance. METHODS: Sixteen patients with bilateral phacoemulsification and multifocal IOL implantation in both eyes (Alcon ReSTOR [n = 8] and AMO Tecnis ZM900 [n = 81) received computer-based visual training 6 weeks postoperatively based on the concept of perceptual learning of discrimination line orientations. The training was performed over 2 weeks in six sessions in one eye of each patient. The untrained fellow eye served as control. Before and after the training period and at 6 months, orientation visual acuity, distance visual acuity, contrast sensitivity, and near visual acuity for different contrast levels were assessed. RESULTS: After 2 weeks of training, the mean improvement of orientation visual acuity in the trained eyes was 82%, which was significantly higher than the control eyes (P < .001). Contrast sensitivity and near vision under different contrast levels showed a significant benefit of training. The superior function of the trained eyes was still present at 6 months. CONCLUSIONS: Visual performance after multifocal IOL implantation can be significantly accelerated by a specific 2-week training program. This effect is sustained over a 6-month period.

Intraindividual comparison of a blue-light filter on visual function: AF-1 (UY) versus AF-1 (UV) intraocular lens.

PURPOSE: To evaluate the effect of the AF-1 (UY) blue-light-filtering intraocular lens (IOL) with a yellow chromophore (Hoya) on visual function, including contrast vision and color perception. SETTINGS: Five clinical ophthalmology centers in Germany. METHODS: Two types of IOLs that were identical except for a blue-light filter on 1 were compared in a prospective randomized multicenter study with intraindividual comparisons. Postoperatively, uncorrected and best corrected visual acuities, pupil size, contrast vision (Early Treatment Diabetic Retinopathy Study chart, functional acuity contrast test, photopic, mesopic, mesopic with glare), and color discrimination (Farnsworth-Munsell 100-hue test, photopic and mesopic) were evaluated. RESULTS: There were no significant differences between the 2 IOLs except in color vision dependent on blue light. Color perception for blue with the blue-light-filtering IOL was significantly reduced under mesopic conditions over the 12-month follow-up and under photopic conditions over 6 months. Despite the difference, all measured total error scores were within normal range and no patient reported impaired color vision. CONCLUSIONS: The blue-light-filtering IOL with a yellow chromophore had no effect on contrast vision and visual acuity. However, the impairment of color perception for blue was statistically significant. The impairment of the blue perception did not exceed the normal range or induce subjective disturbance of color vision.

Optic edge design as long-term factor for posterior capsular opacification rates.

OBJECTIVE: To compare the difference in posterior capsular opacification (PCO) between highly refractive silicone and hydrophobic acrylic foldable intraocular lenses (IOLs) with sharp and round edge designs 3 years after in-the-bag IOL implantation in subjects undergoing bilateral cataract surgery. DESIGN: Open-label, prospective, randomized, multicenter clinical trial. PARTICIPANTS: Two hundred and eighty-eight patients with bilateral surgery for senile cataract operated in German university clinics, eye hospitals, and private ophthalmic surgical centers (Aachen, Ahaus, Bad Hersfeld, Frankfurt/Main, Jena, Rosenheim, and Sulzbach/Saar). INTERVENTIONS: At each center, a highly refractive index silicone IOL with a sharp optic edge (CeeOn) was intraindividually compared either with a high-refractive index silicone IOL with a round optic edge (PhacoFlex) in 108 patients or with an acrylic IOL with a sharp optic edge (AcrySof) in 139 patients. All patients received standard phacoemulsification with IOL implantation in the bag in both eyes from the same surgeon. A morphological evaluation of PCO was performed by the Evaluation of the Posterior Capsule Opacification (EPCO) system 1 to 2 weeks and 11 to 14 and 35 to 37 months after surgery. The blinded digital pictures were evaluated by an independent investigator. Posterior capsular opacification was statistically evaluated by paired comparisons of 3-year cumulative incidences of neodymium:yttrium-aluminum-garnet (Nd:YAG) laser treatment and EPCO scores. MAIN OUTCOME MEASURES: Posterior capsular opacification. RESULTS: The 3-year cumulative incidences of Nd:YAG laser capsulotomy were 2.1% (CeeOn), compared with 2.1% (AcrySof) (risk difference, 0%; 90% confidence interval, -3.4% to 3.4%), and 5.7% (CeeOn), compared with 17.0% (PhacoFlex) (risk difference, -11.4%; 90% confidence interval, -18.1% to -4.7%). In patients without Nd:YAG laser treatment, medians of the total area EPCO score were 0.0005 (CeeOn) versus 0.0440 (AcrySof) and 0 (CeeOn) versus 0.0700 (PhacoFlex) at 3 years. Functional results, safety, and handling did not significantly differ for the 3 lenses. CONCLUSIONS: Our results suggest that modern foldable IOLs have a low incidence of PCO after 3 years. There is less PCO for sharp optic edge designs independent of IOL material.

Functional outcomes after implantation of Tecnis ZM900 and Array SA40 multifocal intraocular lenses.

PURPOSE: To evaluate the functional outcome after implantation of the Tecnis ZM900 multifocal intraocular lens (IOL) (AMO) and the Array SA40 multifocal IOL (AMO). SETTING: Department of Ophthalmology, Bundesknappschaft s Hospital, Sulzbach, and the Department of Ophthalmology, Marienhospital, Aachen, Germany. METHODS: In a prospective comparative 2-center trial, Tecnis ZM900 and the Array SA40 multifocal IOLs were bilaterally implanted in 50 patients (50 eyes Tecnis, 50 eyes Array) by 1 surgeon at each center. The following parameters were assessed 30 to 60 days and 120 to 180 days after surgery in both eyes: refraction, pupil size, uncorrected and best corrected visual acuities for distance and near at different contrast levels, and photopic and mesopic contrast sensitivity at different spatial frequencies. Patient satisfaction (spectacle independence, photic phenomena, overall satisfaction) was assessed by a questionnaire. RESULTS: The main differences between the 2 multifocal IOLs were the better uncorrected near visual acuity (P<.001), distance-corrected near visual acuity (P<.001), the mesopic contrast sensitivity at high spatial frequencies (P<.05) as well as greater independence from spectacles in patients with the Tecnis multifocal IOL, resulting in higher levels of patient satisfaction. CONCLUSION: The aspherical diffractive Tecnis multifocal IOL gave better outcomes than the Array multifocal IOL.

Vitrectomy with removal of the internal limiting membrane in chronic diabetic macular oedema.

PURPOSE: To assess the effect of pars-plana vitrectomy including peeling of the internal limiting membrane (ILM) on the resolution of chronic diabetic macular oedema. METHODS: We performed a prospective evaluation of 60 eyes of 55 patients with chronic diabetic macular oedema who underwent pars-plana vitrectomy with ILM removal. All patients had a history of macular oedema of at least 6 months. In most of the eyes, grid laser photocoagulation had been performed previously. Eyes with further vitreoretinal pathologies such as vitreous haemorrhage, evident macular traction or significant loss of the foveal capillary net were excluded. Fluorescein angiography, funduscopic examination and the assessment of best-corrected visual acuity (BCVA) were performed pre- and postoperatively. The mean duration of follow-up was 3.0 months. Additionally BCVA was inquired of the referring ophthalmologists after a postoperative period of at least 9 months. RESULTS: Fluorescein angiography and clinical examination revealed a decrease of leakage within the macula or a decrease of macular thickening in 55 (93%) eyes. Mean visual acuity (LogMAR) significantly improved from 1.05 preoperatively to 0.87 postoperatively (P=0.0000034). Twenty-six eyes (43%) gained 2 or more lines of vision; four eyes (7%) lost 2 lines. Data concerning BCVA after a follow-up of at least 9 months were available in 37 patients (41 eyes) and confirmed the results 3 months postoperatively. CONCLUSION: Pars-plana vitrectomy with ILM peeling reduced macular oedema in most cases. In contrast, visual acuity improved significantly in 43% of the treated eyes only. The discrepancy between anatomical and functional results of ILM removal in chronic diabetic macular oedema is likely to be caused by structural changes of the macula due to long-standing oedema.

Posterior capsule opacification after implantation of CeeOn Edge 911A, PhacoFlex SI-40NB, and AcrySof MA60BM lenses: one-year results of an intraindividual comparison multicenter study.

PURPOSE: To perform an intraindividual comparison of posterior capsule opacification (PCO) with 2 foldable intraocular lenses (IOLs) and a foldable acrylic IOL 1 year after in-the-bag implantation. SETTINGS: Seven German ophthalmology centers. METHODS: In an open prospective randomized multicenter study, each center intraindividually compared a high-refractive-index, sharp-edged optic silicone IOL (CeeOn Edge 911A, Pharmacia) with a high-refractive-index, round-edged optic silicone IOL (PhacoFlex SI-40NB, Allergan) or a sharp-edged optic acrylic IOL (AcrySof MA60BM, Alcon). Of 288 randomized patients, 247 had standard phacoemulsification with in-the-bag IOL implantation in both eyes by the same surgeon. One eye of each patient received a CeeOn Edge IOL and the fellow eye, an AcrySof or PhacoFlex IOL. A morphologic evaluation of PCO was performed using the Evaluation of Posterior Capsule Opacification (EPCO) system 1 to 2 weeks and 11 to 14 months after surgery. The digital pictures were evaluated by an independent investigator who was blind to the type of IOL. Intraindividual differences in EPCO scores were statistically evaluated by a 1-sided binomial test at an alpha-level of 5%. RESULTS: One year after surgery, 127 patients with the AcrySof IOL and 102 patients with the PhacoFlex IOL in the control eye were reexamined. Functional results, safety, and handling were not significantly different between the 3 IOLs. All reexamined eyes had a very low PCO grade. The EPCO values revealed less PCO in eyes with the CeeOn Edge IOL than in eyes with the AcrySof or PhacoFlex IOL, but the difference was not statistically significant. A neodymium:YAG laser capsulotomy was performed in 1 eye with a CeeOn Edge IOL, 1 eye with an AcrySof IOL, and 2 eyes with a PhacoFlex IOL. CONCLUSIONS: The EPCO PCO grade was low 1 year after implantation of CeeOn Edge 911A, PhacoFlex SI-40NB, and AcrySof MA60BM IOLs; there was no statistically significant difference between the IOLs. The impact of IOL material and edge design on PCO development might be relevant in a long-term follow-up of this study.

Eye models for the prediction of contrast vision in patients with new intraocular lens designs.

Theoretical calculations of the polychromatic modulation transfer function (MTF) and wave-front aberration were performed with physiological eye models. These eye models have an amount of spherical aberration that is representative of a normal population of pseudophakic eyes implanted with two different types of intraocular lens (IOL) made from high-refractive-index silicone. These theoretical calculations were compared with the measured contrast sensitivity function (CSF) under mesopic lighting conditions and with wave-front aberration (obtained with a Hartmann-Shack wave-front sensor) collected from 37 patients bilaterally implanted with the same types of lens. The relationships between the ocular wave-front aberration and the MTF predicted by the eye models and the CSF and the ocular wave-front aberration measured in eyes implanted with IOLs were investigated. The predicted improvements in MTF and wave-front aberration correlated well with the improvements measured in practice. Physiological eye models are therefore useful tools for IOL design.

Impact of a modified optic design on visual function: clinical comparative study.

PURPOSE: To determine whether implantation of an intraocular lens (IOL) with a modified anterior surface designed to compensate for the positive spherical aberration of the cornea in eyes of cataract patients results in improved pseudophakic quality of vision. SETTING: Department of Ophthalmology, Bundesknappschaft's Hospital, Sulzbach, Germany. METHODS: In an intraindividual randomized study of 45 patients with bilateral cataract, an IOL with a modified anterior surface (Tecnis Z9000, Pharmacia) was compared with a biconvex lens with spherical surfaces (SI-40, Allergan). All patients had bilateral cataract surgery; in 1 eye the Z9000 IOL was implanted and in the other, the SI-40 IOL. After 1 and 3 months, the following investigations were performed: assessment of the anterior and posterior segments including IOL decentration and tilt, pupil size, high- and low-contrast visual acuities, photopic and mesopic contrast sensitivities, and wavefront aberration of the cornea and eye. RESULTS: Thirty-seven patients were examined at all follow-up visits. Although the eyes with the Z9000 IOL had significantly better best corrected visual acuity after 3 months, the improved quality of vision was more apparent when assessing low-contrast visual acuity and contrast sensitivity. Wavefront measurements revealed no significant spherical aberration in eyes with a Z9000 IOL but significantly positive spherical aberration in eyes with an SI-40 IOL. CONCLUSIONS: The clinical results confirm the theoretical preclinical calculations that the spherical aberration of the eye after cataract surgery can be eliminated by modifying the anterior surface of the IOL. The Tecnis Z9000 lens compensates for the positive spherical aberration in older eyes. This leads to a significant improvement, particularly in contrast sensitivity and mesopic visual quality.

Vitrectomy with arteriovenous decompression and internal limiting membrane dissection in branch retinal vein occlusion.

PURPOSE: The therapeutic armamentarium for functional improvement after branch retinal vein occlusion (BRVO) is limited with uncertain efficacy. Some surgeons have proposed surgical decompression of the vein at the arteriovenous (AV) crossing. METHODS: Forty-three patients with BRVO were treated in the authors' department from August 1999 to April 2001 with AV decompression. Twenty-five patients with comparable BRVO who refused this surgical intervention served as a control group. All 68 patients received an isovolemic hemodilution therapy for 10 days. The surgical procedure consisted of a standard pars plana vitrectomy and separation of the overlying artery from the vein using microscissors. In 16 cases dissection of the internal limiting membrane (ILM) in the macular area and around the AV crossing was also performed. Assessment of visual acuity, fluorescein angiography, and multifocal electroretinography were performed preoperatively and 6 weeks after surgery in seven patients. RESULTS: Surgical procedure and postoperative course were uneventful. In most of the treated eyes visual acuity improved and fluorescein angiography revealed capillary reperfusion. Functional results in patients with AV decompression were highly significantly better than in the control group. Furthermore, removal of the ILM seems to have an additional beneficial effect on the functional outcome. CONCLUSION: These results demonstrate the therapeutic effect of surgical AV decompression in BRVO. Additional removal of the ILM seems to improve the functional results. Further experience may answer some open questions.

The role of the vitreous in retinal detachment surgery with external buckling.

PURPOSE: To prove the role of the vitreous in retinal detachment surgery with scleral buckling procedures, we retrospectively investigated the charts of patients who were operated on for retinal detachment by scleral buckling between January 1995 and June 1997. METHODS: Out of a total of 718 cases, 41 retinal detachments occurred in previously vitrectomized eyes. The buckling procedure consisted of silicone sponge explants in 513 cases (254 radial, 259 circumferential) and of encircling elements in 202 cases. Three eyes received a temporary balloon. The minimal follow-up was 3 months. RESULTS: After primary surgery in the 677 nonvitrectomized eyes, the retina was attached in 482 eyes (71.2%), after reoperation in 627 eyes (92.6%). With up to 3 reoperations (including vitrectomy with gas or silicone oil tamponade in 79 eyes), the final success rate was 98.7%. The corresponding reattachment rates in the 41 vitrectomized eyes were 82.9% after primary surgery and 97.6% after reoperation. Repeated surgery in 6 eyes consisted of successful internal tamponade by silicone oil. The reattachment rates after primary buckle procedure are of most interest to the role of the vitreous: the highest success rate (82.9%) was achieved in the vitrectomized eyes versus 71.2% in the nonvitrectomized eyes. The difference is statistically not significant. CONCLUSIONS: We therefore conclude that the absence of the vitreous has no adverse effect on the results of buckling procedures for retinal detachment. The choice of the surgical technique in treating retinal detachments in vitrectomized eyes should only determined by retinal findings such as the number and extent of breaks or the presence and stage of proliferative vitreoretinopathy.

[Comparative investigation of the etiology of visual field defects after epimacular surgery]. / Vergleichende Untersuchung zur Genese von Gesichtsfelddefekten nach epimakulärer Chirurgie.

BACKGROUND: Sectorial visual field defects after macular hole surgery were described by several authors. The intraocular gas tamponade is discussed to be a possible causative factor for this complication. PATIENTS AND METHODS: Goldmann perimetry and threshold perimetry were performed preoperatively and 6 weeks postoperatively in 48 patients who underwent epimacular surgery because of macular pucker (23 eyes) or macular holes stage II - IV (25 eyes). Laser polarimetry was performed additionally using the Nerve Fiber Analyzer. The results were compared quantitatively. In all cases an epimacular membrane was peeled off. Eyes with macular holes underwent fluid-gas exchange with SF 6 without drying up the retina completely. RESULTS: No patient showed a sectorial visual field defect. The quantitative comparison of visual field examinations did not prove a difference between both groups. CONCLUSIONS: We could not detect any impairing influence of the intraocular gas tamponade in our patients. Without complete desiccation of the vitreous cavity, visual field defects after macular hole surgery are unlikely.

A comparison of two different formulations of diclofenac sodium 0.1% in the treatment of inflammation following cataract-intraocular lens surgery.

OBJECTIVE: To compare the efficacy, tolerability and local tolerance of diclofenac sodium 0.1% containing hydroxypropylgamma cyclodextrin preserved with benzalkonium chloride 0.005% (Voltaren Ophtha CD), with that of diclofenac sodium 0.1% preserved with thiomersal 0.004% (Voltaren Ophtha) in the treatment of inflammation after cataract-intraocular lens surgery. DESIGN AND SETTING: Randomised 2:1, double-masked, parallel-group study in six centres in Germany. STUDY PARTICIPANTS: 299 patients scheduled to undergo phacoemulsification with posterior chamber intraocular lens implantation. INTERVENTIONS: Study medications were instilled four times in the 30 minutes before surgery and four times daily from the first postoperative day. MAIN OUTCOME MEASURES: The key efficacy variable was the reduction in anterior chamber flare (photons/millisecond) from day 1 to day 6 to 8. Patients underwent comprehensive ocular examinations, including laser flaremetry (KOWA), preoperatively and postoperatively at days 1, 6 to 8 and 24 to 32. RESULTS: 268 patients (Voltaren Ophtha CD 177, Voltaren Ophtha 91) completed the day 6 to 8 visit without any protocol violations. Reduction in the degree of intraocular inflammation with Voltaren Ophtha CD was equivalent to that achieved with Voltaren Ophtha at the day 6 to 8 [95% confidence interval (CI) -3.07 to +0.54] and day 24 to 32 (95% CI -1.44 to +1.40) visits. Although there was no significant (p = 0.464) difference between the two study groups in patients' global assessment of local tolerance at day 24 to 32, ocular discomfort was significantly (p = 0.023) less with Voltaren Ophtha CD compared with Voltaren Ophtha. CONCLUSIONS: Voltaren Ophtha CD was as effective and well tolerated but had less ocular discomfort compared with Voltaren Ophtha in the treatment of ocular inflammation after phacoemulsification with intraocular lens implantation. This new formulation of diclofenac sodium 0.1% may be used as an alternative to the existing formulations of ophthalmic diclofenac sodium 0.1%.

[Highly refractive silicone lens with sharp optic edge (CeeOn Edge, Model 911): one year results of a multicenter clinical trial on performance and efficacy]. / Hochrefraktive Silikonlinse mit scharfer Hinterkante (CeeOn Edge, Modell 911): 1-Jahres-Ergebnisse einer multizentrischen klinischen Studie zur Handhabung und Effizienz.

PURPOSE: To investigate the performance and efficacy of a new high refractive index (1.46) silicone intraocular lens with sharp optic edges. MATERIALS AND METHODS: In this open prospective multicenter study 149 patients underwent cataract surgery and implantation of CeeOn Edge in one eye. Best corrected visual acuity was determined at day 1 - 2, week 1 - 2, month 6 and month 12 postoperatively. Posterior capsule was clinically evaluated according to existence or absence of posterior capsule opacification (PCO). PCO was defined as relevant if the visual acuity loss exceeded at least two lines. The intraoperative handling of the lens was assessed concerning foldability, haptic handling, positioning, unfolding and general assessment. RESULTS: Visual acuity increased from preoperatively 0.3 to 0.9 after one year. PCO with impact on visual acuity (loss of 2 lines or more) was recorded in only two patients, after 2 weeks (YAG) resp. 1 year (no YAG). The handling and implantation was considered to be good to very good. No lens-related complications were seen during the one year study period. CONCLUSIONS: CeeOn Edge, Model 911, restores visual acuity after cataract surgery and shows promising handling results. The low rate of PCO and YAG is most probably related to the sharp edge of the lens.