Two-year results after combined phacoemulsification and iris-fixated phakic intraocular lens removal.

PURPOSE: To describe and present results after a technique for cataract surgery combined with explantation of an iris-fixated phakic intraocular lens (IF-pIOL). METHODS: The medical records of all patients, who had undergone cataract surgery combined with IF-pIOL explantation and subsequent implantation of a posterior chamber IOL by the Single Incision Technique (SIT), were reviewed. Data collection included preoperative and postoperative corrected distance visual acuity (CDVA), manifest refraction, and endothelial cell density (ECD) up to a follow-up time of 24 months. RESULTS: Fifty myopic eyes (34 patients) and 9 hyperopic eyes (6 patients) had undergone a SIT procedure mainly because of cataract (67%). Postoperative CDVA improved in both the myopic eyes to 0.16 ± 0.37 logMAR, as in the hyperopic eyes to - 0.10 ± 0.55 logMAR with no eyes having loss of Snellen lines. Mean postoperative spherical equivalent was - 0.34 ± 0.72 D and - 0.10 ± 0.55 D, respectively. ECD loss 6 months after surgery was 5% and remained stable thereafter. CONCLUSION: SIT for combined phacoemulsification and IF-pIOL removal yields good visual and refractive results and is a safe procedure in regard to ECD loss. The technique has advantages over the conventional procedure and is easy to perform.

Allogeneic Serum Eye Drops: A Randomized Clinical Trial to Evaluate the Clinical Effectiveness of Two Drop Sizes.

INTRODUCTION: Allogeneic serum from blood donors is starting to be used to treat patients with dry eye disease (DED). However, the optimal dose is not known. We therefore aimed to evaluate the clinical efficaciousness and user-friendliness of micro-sized versus conventional-sized allogeneic serum eye drops (SEDs). METHODS: In a randomized trial, patients with DED first receive micro-sized SEDs (7 µl/unit) for 1 month, followed by a 1-month washout, before receiving conventional-sized SEDs (50 µl/unit) for 1 month; or vice versa. The primary endpoint was the Ocular Surface Disease Index (OSDI) score. Secondary endpoints were tear break-up time (TBT), tear production (TP), and presence of corneal punctate lesions (CP). The user-friendliness of both application systems was also compared. A linear mixed model for cross-over design was applied to compare both treatments. RESULTS: Forty-nine patients completed the trial. The mean OSDI score significantly improved from 52 ± 3 to 41 ± 3 for micro-sized SEDs, and from 54 ± 3 to 45 ± 3 for conventional-sized SEDs. Non-inferiority (margin = 6) of micro-sized SEDs was established. We demonstrate a significant improvement for TBT in case of conventional-sized SEDs and for CP in both treatment groups. TP trended towards an improvement in both treatment groups. The user-friendliness of the conventional drop system was significantly higher. CONCLUSIONS: For the first time, non-inferiority of micro-sized allogeneic SEDs was established. The beneficial effect of both SED volumes was similar as measured by the OSDI score. Although user-friendliness of the micro drop system was significantly lower, it is an attractive alternative as it saves valuable donor serum. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03539159).

Endothelial cell loss and visual outcome of deep anterior lamellar keratoplasty versus penetrating keratoplasty: a randomized multicenter clinical trial.

OBJECTIVE: To compare endothelial cell (EC) loss, visual and refractive outcomes, and complications after deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PK). DESIGN: Randomized, multicenter clinical trial. PARTICIPANTS: Fifty-six eyes of 56 patients with a corneal stromal pathology not affecting the endothelium were randomized to DALK or PK. METHODS: The DALK procedure was performed according to Anwar's big-bubble technique. Patients underwent an ophthalmic examination preoperatively and 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES: Endothelial cell loss, refractive and topographic astigmatism, spherical equivalent, uncorrected visual acuity, and best spectacle-corrected visual acuity (BSCVA) were measured, and complications were recorded. RESULTS: Endothelial cell loss was significantly higher after PK compared with DALK procedures performed without perforation of Descemet's membrane (12 months: 27.7% ± 11.1% vs. 12.9% ± 17.6%). The BSCVA was significantly better in the PK group at 3 and 6 months after surgery but was not significantly different 12 months after surgery (0.39 ± 0.3 logarithm of the minimum angle of resolution [logMAR] in DALK and 0.31 ± 0.3 logMAR in PK). At 12 months postoperatively, refractive and topographic astigmatism in the DALK and PK groups were -3.37 ± 2.3 diopters (D) and -3.76 ± 2.1 D (P = 0.53), and 3.57 ± 2.3 D and 4.16 ± 2.0 D (P = 0.34), respectively. (Micro)perforation of the Descemet's membrane occurred in 32% (9/28) of the DALK eyes, and 18% (5/28) of the patients required conversion to PK. Endothelial cell loss was not significantly different between DALK and PK when cases with perforation of Descemet's membrane were included in the (intention-to-treat) analysis (12 months: 19.1 ± 21.6 vs. 27.7 ± 11.1 P = 0.112). Rejection episodes were reported in 1 patient in the DALK group (epithelial rejection) and 3 patients in the PK group (all endothelial rejections). No graft failure occurred. CONCLUSIONS: One year after DALK performed without perforation of Descemet's membrane, EC loss is significantly lower, whereas the BSCVA is comparable to that in the PK group. In addition, no endothelial rejection occurred in the DALK group. However, Descemet's membrane perforation remains a major complication in DALK and warrants improvements to standardize the big-bubble technique.

Implantation of an iris-fixated phakic intraocular lens for the correction of hyperopia: 15-year follow-up.

PURPOSE: To assess the predictability, efficacy, stability, and safety of implantation of an Artisan iris-fixated phakic intraocular lens (IF-pIOL) for the correction of hyperopia with a follow-up of up to 15 years. SETTING: Leiden University Medical Center, the Netherlands. METHODS: Patients operated by a single surgeon up to 2007 were identified, and data on refraction, corrected distance visual acuity (CDVA), uncorrected distance visual acuity, endothelial cell (EC) density, and complications were collected. RESULTS: A total of 61 eyes (32 patients) were analysed. The mean spherical equivalent decreased from +6.43 ± 1.78 diopters (D) preimplantation to -0.22 ± 0.57 D at 1 year postimplantation and remained stable throughout follow-up. A stable CDVA with safety indices ranging from 0.91 to 1.10 and efficacy indices between 0.43 and 0.86 were observed. Follow-up time had a significant effect on EC density with an estimated annual decline of 58 cells/mm2 after IF-pIOL implantation. IF-pIOL explantation was performed in a 10 eyes (16.4%) after 8.13 ± 5.11 years. The main reason for IF-pIOL explantation was EC loss (4 eyes [6.6%]). Pigment dispersion was the most encountered complication, observed in 9 eyes (14.8%). CONCLUSIONS: Visual and refractive results after implantation of an IF-pIOL to correct hyperopia show favorable and stable results with long-term follow-up. Lifelong monitoring of EC counts is mandatory. Pigment dispersion might be a problem in hyperopic eyes implanted with an IF-pIOL; a shallower anterior chamber depth and a convex iris configuration might be predisposing factors.

Middle- and long-term results after iris-fixated phakic intraocular lens implantation in myopic and hyperopic patients: a meta-analysis.

The iris-fixated phakic intraocular lens (pIOL) has been available for over 25 years. To provide a clear picture of outcomes and risks, for this systematic review and meta-analysis, the literature was searched for reports on middle- and long-term effects. The iris-fixated phakic intraocular lens (pIOL) has been available for over 25 years. To provide a clear picture of outcomes and risks, for this systematic review and meta-analysis, the literature was searched for reports on middle- and long-term effects of iris-fixated pIOLs on myopic and hyperopic eyes with a follow-up of at least 2 to 4 years. Visual and refractive results after implantation for correction of myopia are positive and the complication rate is low. Endothelial cell loss appears to be at an acceptable rate, although the range of endothelial cell change is too wide to draw firm conclusions. Care should be taken when considering an iris-fixated pIOL for hyperopic eyes because complication rates, particularly pigment dispersion, might be higher than those in myopic eyes. More well-designed, long-term studies are needed, especially in hyperopic eyes. The authors advocate for standardized reporting of refractive surgery data. Initiatives proposed by journal authors and editors to achieve uniformity should be supported.

The rising incidence of Acanthamoeba keratitis: A 7-year nationwide survey and clinical assessment of risk factors and functional outcomes.

PURPOSE: To evaluate the incidence of Acanthamoeba keratitis in the Netherlands between 2009 and 2015 and to analyse predicting factors for treatment outcome. METHODS: Patient characteristics, diagnostic methods, diagnostic delay, therapy prior to and after diagnosis, and visual outcome were obtained from medical files of all patients diagnosed with Acanthamoeba keratitis in the Netherlands between 2009 and 2015. A logistic regression analysis on treatment failure, defined as a best corrected visual acuity of less than 20/40 Snellen decimals (i.e. >0.3 logMAR or an approximate loss of three lines of visual acuity) and/or the need for keratoplasty, was performed to determine predicting factors. RESULTS: Two hundred and twenty-four eyes of 224 patients were included. Ninety-five percent of the patients were contact lens wearers, of whom 74% wore soft contact lenses. The number of cases increased from 16 in 2009 to 49 in 2015. This resulted in an estimated incidence of 1 in 21,000 for soft contact lens wearers in 2015. Eighty-seven eyes (39%) met the criteria for treatment failure. In a multivariable regression analysis, higher age at presentation, a higher severity stage and corticosteroid use before diagnosis were positively correlated with treatment failure. Early referral to a cornea specialist was associated with better clinical outcomes. CONCLUSIONS: Although Acanthamoeba keratitis is still a relatively uncommon disease, the incidence in soft contact lens wearers has increased to reach 1 in 21,000 in 2015. Treatment failure occurred in 39% of cases, with age, higher severity stage, corticosteroid use before diagnosis and indirect referral to a cornea specialist as important risks factors.

Long-term follow-up of a multifocal apodized diffractive intraocular lens after cataract surgery.

PURPOSE: To report the long-term performance of the AcrySof ReSTOR SA60D3 intraocular lens (IOL) after cataract surgery. SETTING: University Hospital Maastricht, Maastricht, The Netherlands. METHODS: This prospective clinical trial comprised 44 eyes (22 consecutive patients) having cataract surgery with implantation of the ReSTOR IOL. Monocular and binocular uncorrected distance visual acuity, best corrected distance visual acuity, uncorrected near visual acuity, best distance-corrected near visual acuity, spectacle dependence, undesired visual symptoms, patient satisfaction, and incidence of posterior capsule opacification were analyzed 6 months and 3 years postoperatively. RESULTS: The mean uncorrected distance acuity (logMAR) was 0.046 +/- 0.099 at 6 months and 0.115 +/- 0.173 at 3 years and the mean best corrected distance acuity, -0.040 +/- 0.075 and -0.018 +/- 0.093, respectively. Binocular uncorrected and best-corrected near acuities (logMAR) were 0.009 +/- 0.029 at 6 months and 0.014 +/- 0.035 at 3 years. All patients achieved a binocular uncorrected and best distance-corrected near acuity of 20/25 or better at 6 months and 3 years. On a quality-of-life questionnaire, patients reported good distance, intermediate, and near acuity without complaints of severe glare or halos. Complete spectacle independence for distance and near acuity was achieved by 83.7% and 81.9% of patients, respectively, at 6 months and 85.0% and 75.0% of patients, respectively, at 3 years. Four eyes (9.1%) required neodymium:YAG capsulotomy. CONCLUSIONS: Cataract surgery with the AcrySof ReSTOR SA60D3 IOL provided good, stable distance and near visual acuities over a 3-year follow-up, leading to low spectacle independence and high patient satisfaction.

Intraocular straylight after implantation of the multifocal AcrySof ReSTOR SA60D3 diffractive intraocular lens.

PURPOSE: To measure intraocular straylight (as a measure of glare) after cataract surgery and implantation of an AcrySof ReSTOR SA60D3 multifocal or AcrySof SA60AT monofocal intraocular lens (IOL) (both Alcon Laboratories). SETTING: University Hospital Maastricht, Maastricht; Isala Clinics, Zwolle; Netherlands Institute for Neurosciences, Amsterdam, The Netherlands. METHODS: In a prospective open observational case series, a newly developed straylight meter was used to objectively measure straylight 6 months postoperatively in 66 eyes with a diffractive AcrySof ReSTOR SA60D3 IOL (multifocal group) and 40 eyes with a monofocal AcrySof SA60AT IOL (monofocal group). A comparison of straylight levels in an age-matched population without cataract (control group) was performed. RESULTS: The straylight level was 1.20 log units +/- 0.16 (SD) in the multifocal group and 1.10 +/- 0.19 log units in the monofocal group. When the difference in mean level of straylight was adjusted for age, mean straylight levels were 0.078 log units lower in the monofocal group than in the multifocal group (P = .026). Straylight levels in both pseudophakic groups were lower than in the control group without cataract (P< .0001). CONCLUSIONS: Levels of intraocular straylight log(s) were significantly lower for both types of IOL than in age-matched subjects from the normal population. The mean level of intraocular straylight 6 months postoperatively was higher in patients with an AcrySof ReSTOR SA60D3 IOL than in patients with a monofocal AcrySof SA60AT IOL. Implantation of the former IOL would therefore result in a smaller gain in contrast sensitivity and a smaller reduction in glare and halos than implantation of the latter IOL.

Femtosecond-laser-assisted Descemet's stripping endothelial keratoplasty.

To our knowledge, we describe the first patient with pseudophakic bullous keratoplasty treated with femtosecond-laser-assisted endothelial keratoplasty. A 5.5 mm corneoscleral tunnel incision was made; after Descemet's membrane was stripped, an 8.0 mm posterior lamellar corneal disk prepared with a femtosecond laser was inserted into the anterior chamber against the recipient cornea without the use of corneal sutures. Four months postoperatively, the posterior corneal disk was clear and the induced astigmatism was 2.1 diopters, demonstrating a functional corneal endothelial layer. The femtosecond laser offers a new surgical approach for minimally invasive endothelial keratoplasty in corneal endothelial disorders.

Corneal endothelial viability after femtosecond laser preparation of posterior lamellar discs for Descemet-stripping endothelial keratoplasty.

PURPOSE: To evaluate the feasibility of the femtosecond (FS) laser in preparation of posterior lamellar discs (PLDs) and to study the effect on endothelial cell (EC) viability for Descemet-stripping endothelial keratoplasty. METHODS: Fourteen human donor bulbi unsuitable for transplantation were used. A horizontal lamellar cut was prepared in the donor cornea with an FS laser by using a raster and/or a spiral spot pattern. The control group consisted of the paired cornea of the same donor. EC density was evaluated before and after preservation in organ culture. The PLD was stripped from the anterior part by using either a forceps or a blunt dissection technique. The damage to the endothelium was evaluated. RESULTS: EC loss after organ storage was not statistically significant between the FS cornea group and the control group in the 15- (7.7% +/- 6.9% and 8.9% +/- 8.1%, respectively; P = 0.78) and 30-kHz (4.3% +/- 4.0% and 3.7% +/- 3.6%, respectively; P = 0.75) group. There was no significant effect of laser frequency (15 vs. 30 kHz) on EC loss (7.7% vs. 4.3%, P = 0.25). Dissection by using a forceps stripping technique resulted in higher EC loss than that with a blunt dissection technique (13.0% vs. 6.5%, P = 0.03). CONCLUSIONS: EC loss after FS laser lamellar cutting is not dependent on the frequency (ie, energy level) of the laser. A blunt dissection technique of PLDs resulted in acceptable EC loss and supports the clinical use of the FS laser for the preparation of PLDs.

Three-year follow-up analysis of Artisan toric lens implantation for correction of postkeratoplasty ametropia in phakic and pseudophakic eyes.

PURPOSE: To determine the 3-year follow-up of efficacy and safety of Artisan toric iris-fixated lens implantation after penetrating keratoplasty (PK) to correct high ametropia and astigmatism. DESIGN: Prospective noncomparative case series with a minimum follow-up of 1 year. PARTICIPANTS: Artisan toric lens implantation was performed in 36 eyes of 35 patients who were contact lens intolerant or unable to wear glasses due to anisometropia and/or high astigmatism. INTERVENTION: Thirty-six eyes of 35 consecutive patients received Artisan toric lens implantation for postkeratoplasty astigmatism and/or anisometropia. MAIN OUTCOME MEASURES: Manifest refraction, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), and corneal topography were determined or performed before surgery and at 3, 6, and 12 months and yearly intervals up to 4 years after surgery. Efficacy, safety, percent reduction of refractive astigmatism, anisometropia of defocus, and the astigmatism correction index were determined. A patient satisfaction questionnaire and specular microscopy were assessed. RESULTS: The mean +/- standard deviation of preoperative refractive cylinder was -7.06+/-2.01 diopters (D) (range, -3.0 to -11.0), which was reduced to -1.73+/-1.25 D, -1.69+/-1.15 D, -1.94+/-1.68 D, -2.02+/-1.93 D, and -2.00+/-1.53 D at 6 months (n = 36), 1 year (n = 36), 2 years (n = 29), 3 years (n = 15), and the last follow-up examination (28.5+/-12.5 months, n = 36), respectively (P<0.001 for all time points, paired t test). The spherical equivalent was reduced from -3.19+/-4.31 D (range, +5.5 to -14.25 D) preoperatively to -1.03+/-1.20 D (range, +1.0 to -5.25 D) at the last follow-up. The UCVA and BSCVA were > or =20/40 in 31.6% and 80.6%, respectively. There was a loss of BSCVA of >2 lines in 8.3% of eyes and a gain of at least 2 lines in 8.3% of eyes. Percent reductions in refractive astigmatism and anisometropia of defocus were 88.8%+/-29.5% and 77.8%+/-19.3%, respectively. The astigmatism correction index was 96.0%+/-24.2%. Satisfaction increased from 3.6 to 8.0 (scale, 0-10) after implantation. The endothelial cell loss as compared with preoperatively was 13.8%+/-18.7% (n = 34), 21.2%+/-21.8% (n = 33), 29.6%+/-27.3% (n = 26), 30.4%+/-32.0% (n = 18), and 34.8%+/-26.3% (n = 6) at 6 months (P = 0.001), 1 year (P<0.001), 2 years (P<0.001), 3 years (P = 0.001), and 4 years postoperatively (P = 0.1), respectively. In 2 patients, irreversible graft rejections occurred, and in 1 patient, gradual endothelial decompensation occurred. CONCLUSION: Artisan toric lens implantation after PK was effective for reduction of refractive astigmatism and ametropia. All patients were suitable for spectacle correction after implantation. There was continuing endothelial cell loss from 6 months to 3 years postoperatively. In 3 cases, corneal graft failure developed.

Relationship between retinal detachment and biometry in 4262 cataractous eyes.

PURPOSE: To assess risk factors for retinal detachment (RD) in eyes that previously underwent cataract surgery. DESIGN: Retrospective cohort study. PARTICIPANTS: Four thousand two hundred sixty-four eyes of 3094 patients who underwent extracapsular cataract extraction with intraocular lens (IOL) implantation at the Department of Ophthalmology, Erasmus MC, University Medical Center Rotterdam. METHODS: From January 1, 1993, through March 31, 1999, 3094 patients (4262 cases) of extracapsular cataract extraction with IOL implantation were enrolled. Through review of ophthalmic patient records, the role of preoperative and intraoperative data as well as neodymium:yttrium-aluminum-garnet (Nd:YAG) capsulotomy was assessed with respect to development of an RD. MAIN OUTCOME MEASURES: Axial length (AL), anterior chamber depth (ACD), crystalline lens thickness, mean keratometric power, spherical equivalent, intraoperative complications, Nd:YAG laser posterior capsulotomy, RD. RESULTS: Of 4262 eyes that underwent cataract extraction, 3921 eyes (2794 patients) were available for analysis. Twenty-two patients experienced RD after surgery, resulting in an overall cumulative incidence of 0.62%. Multivariate binary logistic regression analyses showed the following factors to be associated with an increased risk of RD after cataract surgery: an accidental posterior capsular rupture at the time of surgery (odds ratio [OR] = 16.26; P<0.001), an increased AL (OR = 1.25; P = 0.013), and a deeper anterior chamber (OR = 4.02; P = 0.016). Older age was found to be a protective factor for the development of RD (OR = 0.95; P = 0.003). CONCLUSIONS: Cataract surgery at a young age with an accidental posterior capsular rupture and a deeper ACD are the most important predisposing conditions for pseudophakic RD after cataract surgery. The overall cumulative incidence of 0.62% for postoperative RD is low.

Effects of graft thickness and asymmetry on visual gain and aberrations after descemet stripping automated endothelial keratoplasty.

IMPORTANCE: Understanding the contribution of graft thickness and asymmetry to visual gain and posterior corneal (PC) higher-order aberrations (HOAs) may assist optimizing visual outcomes after Descemet stripping automated endothelial keratoplasty (DSAEK). OBJECTIVE: To investigate the effects of graft thickness and asymmetry on visual gain and aberrations after DSAEK. DESIGN: Retrospective analysis of an interventional case series of eyes undergoing DSAEK. Visual gain was defined as the difference between preoperative and 6-month postoperative best-corrected visual acuity in logMAR equivalents. Graft thickness was measured by anterior-segment optical coherence tomography. Corneal topography and HOAs were measured by Scheimpflug imaging. Raw posterior corneal (PC) elevation data were exported and fitted against a best-fitted sphere, providing a measure of donor lenticule asymmetry. Correlation analysis was performed among visual gain, graft thickness, graft asymmetry, and PC HOAs. SETTING: University Eye Clinic Maastricht. PARTICIPANTS: Seventy-nine eyes with corneal endothelial dysfunction. EXPOSURE: All patients underwent DSAEK [corrected]. MAIN OUTCOMES AND MEASURES: Visual gain, graft thickness, graft asymmetry, and PC HOAs. RESULTS: Mean best-corrected visual acuity improved from 0.63 logMAR equivalents preoperatively to 0.25 logMAR equivalents postoperatively (P < .001). Mean (SD) graft thickness of the series was 97 (25) (range, 39-145) µm. After excluding patients with vision-limiting comorbidities, visual gain significantly correlated with graft thickness (r = -0.35 [P = .02]). This correlation was strongest in patients with pseudophakic bullous keratopathy (r = -0.62 [P = .01]). Graft thickness significantly correlated with graft asymmetry in the 4- and 6-mm zones (r = 0.32 [P = .007] and r = 0.32 [P = .006], respectively), which in turn correlated with all but spherical PC HOAs. CONCLUSIONS AND RELEVANCE: After DSAEK, visual gain shows a significant correlation with graft thickness in patients without vision-limiting comorbidities. This relationship is strongest in patients with pseudophakic bullous keratopathy. Graft thickness also correlates with graft asymmetry, which in turn correlates with all but spherical PC HOAs. These findings may assist surgeons in choosing DSAEK graft thickness and shape, particularly in eyes without vision-limiting comorbidities. Further randomized trials are needed to investigate the relationship between graft thickness and visual gain after DSAEK.

Economic evaluation of endothelial keratoplasty techniques and penetrating keratoplasty in the Netherlands.

PURPOSE: To evaluate cost-effectiveness of penetrating keratoplasty (PK), femtosecond laser-assisted Descemet stripping endothelial keratoplasty (FS-DSEK), and Descemet stripping automated endothelial keratoplasty (DSAEK). DESIGN: Cost-effectiveness analysis based on data from a randomized multicenter clinical trial and a noncomparative prospective study. METHODS: Data of 118 patients with corneal endothelial dysfunction were analyzed in the economic evaluation. Forty patients were included in the PK group, 36 in the FS-DSEK group, and 42 in the DSAEK group. The primary incremental cost-effectiveness ratio (ICER) was the incremental costs per clinically improved patient, defined as a patient with a combined effectiveness of both a clinically improved BSCVA (defined as an improvement of at least 2 lines) and a clinically acceptable refractive astigmatism (defined as less than or equal to 3.0 diopters). Analysis was based on a 1-year follow-up period after transplantation. RESULTS: The percentage of treated patients who met the combined effectiveness measures was 52% for DSAEK, 44% for PK, and 43% for FS-DSEK. Mean total costs per patient were €6674 (US$7942), €12 443 (US$14 807), and €7072 (US$8416) in the PK group, FS-DSEK group, and DSAEK group, respectively. FS-DSEK was less effective and more costly compared to both DSAEK and PK. DSAEK was more costly but also more effective compared to PK, resulting in incremental costs of €4975 (US$5920) per additional clinically improved patient. CONCLUSIONS: The results of this study show that FS-DSEK was not cost-effective compared to PK and DSAEK. DSAEK, on the other hand, was more costly but also more effective compared to PK. Including societal costs, a longer follow-up period and preparation of the lamellar transplant buttons in a national cornea bank could improve the cost-effectiveness of DSAEK.

Quality of vision after femtosecond laser-assisted descemet stripping endothelial keratoplasty and penetrating keratoplasty: a randomized, multicenter clinical trial.

PURPOSE: To compare the quality of vision (straylight and contrast sensitivity) after femtosecond laser-assisted Descemet stripping endothelial keratoplasty (FS DSEK) and penetrating keratoplasty (PK). DESIGN: Prospective, randomized clinical trial. METHODS: setting: Multicenter (5 ophthalmic centers in The Netherlands). study population: Eighty eyes of 80 patients with corneal endothelial dysfunction were included and were randomized to FS DSEK or PK. observation procedures: FS DSEK and PK. main outcome measures: Straylight, contrast sensitivity, astigmatism, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and visual symptom score. RESULTS: Straylight at 12 months was 1.37 ± 0.2 logarithm of straylight for FS DSEK and 1.46 ± 0.2 logarithm of straylight for PK (P = .151). During 12 months of follow-up, there was a significant improvement of straylight and contrast sensitivity after FS DSEK (P < .001) and PK (P < .001). The change of straylight and contrast sensitivity correlated significantly with the change of BSCVA after FS DSEK (r = -0.645; r = 0.580) and PK (r = -0.370; r = 0.659). The visual symptom score was comparable between the 2 groups during the 12 months of follow-up. CONCLUSIONS: Improvement of straylight and contrast sensitivity was significantly correlated with an improvement of BSCVA. Straylight and contrast sensitivity were improved significantly after FS DSEK and were comparable with those after PK, although BSCVA was slightly better in the PK group.

Economic evaluation of deep anterior lamellar keratoplasty versus penetrating keratoplasty in The Netherlands.

PURPOSE: To evaluate the cost effectiveness of deep anterior lamellar keratoplasty (DALK) versus penetrating keratoplasty (PK) in The Netherlands. DESIGN: Cost-effectiveness analysis alongside a randomized, multicenter clinical trial. METHODS: Fifty-three patients with corneal stromal pathologic features not affecting the endothelium were included with 28 patients in the DALK group and 25 in the PK group. Quality of life was measured before surgery and 3, 6, and 12 months after surgery. The main outcome measures were incremental cost-effectiveness ratios per clinically improved patient on the 25-item National Eye Institute Visual Functioning Questionnaire and per patient with endothelial cell loss of maximally 20% within the first year. RESULTS: Mean total bootstrapped costs per patient were €7607 (US$10,498) in the DALK group and €6552 (US$9042) in the PK group. The incremental cost-effectiveness ratios were €9977 (US$13,768) per clinically improved patient on the 25-item National Eye Institute Visual Functioning Questionnaire and €6900 (US$9522) per patient with cell loss of maximally 20%. In patients without perforation of the Descemet membrane, the incremental cost-effectiveness ratio was €5250 (US$7245) per patient. CONCLUSIONS: This study shows that DALK is more costly and more effective as compared with PK. Results on the 25-item National Eye Institute Visual Functioning Questionnaire were in favor of DALK, and endothelial cell loss in DALK patients remained stable after 6 months, whereas cell loss in PK patients continued. Furthermore, DALK procedures performed without perforation of the Descemet membrane were more effective. However, because it is unknown what society is willing to pay for an additional improved patient, cost effectiveness of DALK within a limited follow-up period of 12 months is unclear. Cost effectiveness of DALK may improve over time because of lower graft failure.

Visual outcome and patient satisfaction after multifocal intraocular lens implantation: aspheric versus spherical design.

PURPOSE: To evaluate visual outcomes and patient satisfaction after implantation of an aspheric apodized diffractive intraocular lens (IOL) or a spherical apodized diffractive IOL in cataract surgery. SETTING: Maastricht University Medical Center, The Netherlands. DESIGN: Nonrandomized clinical trial. METHODS: This prospective nonrandomized study with a 6-month follow-up compared the results of cataract surgery with implantation of an aspheric AcrySof ReSTOR SN6AD3 IOL and a spherical AcrySof ReSTOR SN60D3 IOL. Main outcome measures were uncorrected (UDVA) and corrected (CDVA) distance visual acuities, uncorrected (UNVA) and distance-corrected (DCNVA) near visual acuities, straylight levels, incidence of glare and halos, and contrast sensitivity levels. RESULTS: The mean UDVA was 0.14 ± 0.15 logMAR in the aspheric group (47 eyes) and 0.14 logMAR ± 0.17 (SD) in the spherical group (45 eyes) and the mean CDVA, -0.01 ± 0.06 logMAR and 0.02 ± 0.10 logMAR, respectively. The mean UNVA was Jaeger (J) 1 in 83.0% of patients in the aspheric group and 55.5% of patients in the spherical IOL group (P = .003). The DCNVA was J1 in 95.7% and 71.1%, respectively (P = .001). There were no significant differences between the 2 groups in contrast sensitivity levels, intraocular straylight levels, incidence of night-vision symptoms, or subjective rating of vision. CONCLUSIONS: Patients with the aspheric multifocal IOL had significantly better near vision than patients with the multifocal spherical IOL. The UDVA, CDVA, intraocular straylight, night-vision symptoms, and contrast sensitivity were similar between the 2 groups.

Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial.

BACKGROUND: To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. METHODS: A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease were randomized to FLEK or PK. Clinical outcomes (astigmatism and visual acuity) and incidence of postoperative complications were compared between the two groups. RESULTS: At 12 months, the percentage of eyes with a refractive astigmatism less than or equal to 3 diopters was higher in the FLEK group in comparison with the PK group (86.2% vs. 51.3%, P=0.004). The mean postoperative best corrected visual acuity was 20/70+/-2 lines in the FLEK group and 20/44+/-2 lines in the PK group (P<0.001), but the gain in the best corrected visual acuity between the two groups was not significantly different. The endothelial cell loss in the FLEK and PK group was 65+/-12% and 23+/-15% (P<0.001). The most common postoperative complication in the FLEK group was graft dislocation (27.8%). Wound healing related problems occurred in six eyes (15%) in the PK group and in none of the FLEK eyes. CONCLUSIONS: FLEK effectively reduces postoperative astigmatism and results in an absence of wound healing related problems in patients with endothelial disease. However, visual acuity is lower as compared with conventional PK, and the high level of endothelial cell loss warrants a modification of the insertion technique of the endothelial graft.