Bettina C Thomas

Femtosecond laser correction of presbyopia (INTRACOR) in emmetropes using a modified pattern.

PURPOSE To evaluate functional results and corneal changes after femtosecond laser correction of presbyopia (INTRACOR, Technolas Perfect Vision GmbH) in emmetropes using a modified treatment pattern over a 12-month period. METHODS Twenty eyes from 20 emmetropic patients were treated with a modified intrastromal INTRACOR pattern consisting of 5 central rings and 8 radial cuts in a prospective, nonrandomized, uncontrolled, open, single-center, clinical study. Refraction, visual acuity, endothelial cell density, corneal pachymetry, total corneal power, and stray light were evaluated preoperatively and 1 (except endothelial cell density and stray light), 3, 6, and 12 months postoperatively. Patients filled out a subjective questionnaire at 12 months postoperatively. RESULTS Comparison of preoperative versus 12-month postoperative median values revealed a significant improvement in uncorrected near visual acuity (UNVA) from 0.60 (20/80) to 0.10 logMAR (20/25) (P<.0001) and a significant decrease in corrected distance visual acuity (CDVA) from -0.10 (20/16) to 0.00 logMAR (20/20), which equals a median loss of one line (P=.0005). Fifteen percent of patients lost two lines of CDVA in the treated eye. Subjective spherical equivalent refraction remained unchanged at 0.00 diopters (D) (P=.194). After INTRACOR treatment, significant corneal steepening of 1.40 D and midperipheral flattening of 0.50 D occurred (both P<.0001). Corneal pachymetry at the thinnest point and endothelial cell density did not change significantly (P=.829 and P=.058, respectively). CONCLUSIONS After 12 months, the modified INTRACOR pattern improved UNVA in emmetropic patients without inducing a myopic shift or significant changes in endothelial cell density or pachymetry.

Severe Arthrographis kalrae keratomycosis in an immunocompetent patient.

Purpose: To describe a severe case of keratomycosis caused by Arthrographis kalrae requiring repeated keratoplasty. Methods: A 42-year-old otherwise healthy soft contact lens wearer developed a unilateral central corneal ulcer. Treatment with topical and systemic voriconazole is described. Results: Repeated microbiological testing of ocular swabs (culture) initially yielded Candida albicans. Under treatment with topical clotrimazole, the ulcer progressed, and a corneal perforation required a keratoplasty à chaud. For prophylaxis, the patient received fluconazole systemically and continuous topical clotrimazole. However, in 2 weeks time, the mycotic infiltrates penetrated the corneal transplant and led to a second keratoplasty only 1 month after the first one. In the meantime, the microbiological analysis of the first keratoplasty revealed A. kalrae, which was sensitive to voriconazole. High-dose serum level-controlled systemic voriconazole and topical voriconazole were able to stabilize, but not eliminate the infection. About 1 year after the start of the voriconazole therapy, treatment had to be discontinued because of side effects. Mycotic infiltrates increased, and even an intracameral voriconazole injection could not prevent a third and a fourth keratoplasty. Conclusions: Ocular infection with A. kalrae is very rare. The microbiological differentiation of A. kalrae can be difficult. Because a broad spectrum of fungi is sensitive to voriconazole, the early topical and possibly systemic treatment is a reasonable therapeutic option when a mycotic infection of the eye is suspected, even before the causative fungus is identified.

Comparison of a new image-guided system versus partial coherence interferometry, Scheimpflug imaging, and optical low-coherence reflectometry devices: Keratometry and repeatability

Purpose To determine the repeatability of keratometry of the Verion image‐guided system and to compare the keratometry (K) values with those of established biometric devices. Setting International Vision Correction Research Centre, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. Design Prospective case series. Methods One randomly chosen eye of volunteers was examined with partial coherence interferometry (PCI) (IOLMaster 500), optical low‐coherence reflectometry (OLCR) (Lenstar LS 900), a Scheimpflug device (Pentacam HR), and the new image‐guided system by the same examiner. None of the eyes had ocular pathology. Three consecutive measurements were performed with the image‐guided system and 1 with the other devices. The flat, steep, and average corneal radii; steep axis; and white‐to‐white (WTW) distance were analyzed and compared. Results One hundred twenty‐three eyes of 123 volunteers (mean age 37.9 years ± 16.2 [SD]) had valid measurements for all examinations and were available for analysis. The image‐guided system measured statistically significant smaller flat, steep, and average corneal radii than the Scheimpflug device, statistically significant larger flat and average corneal radii than the PCI device, and no statistically significant different values than the OLCR device. The measured steep axis did not differ significantly in any comparison. The WTW measurements were significantly higher than those of all other devices. The analysis of repeatability of the image‐guided system showed high intraclass correlation coefficients (range 0.919 to 0.997). Conclusions The new image‐guided system had high repeatability for K, steep axis, and WTW measurements. The WTW measurements with the image‐guided system were significantly higher than those using the other devices. Financial Disclosure None of the authors has a financial or proprietary interest in any material or method mentioned.

Intrastromal femtosecond laser surgical compensation of presbyopia with six intrastromal ring cuts: 3-year results

Background/aims To assess over a 36-month period functional results of the modified INTRACOR femtosecond laser-based intrastromal procedure to treat presbyopia. Methods 20 eyes of 20 presbyopic patients with mild hyperopia were included. The INTRACOR procedure with a modified pattern (six concentric intrastromal ring cuts) was performed using the FEMTEC femtosecond laser (Bausch+Lomb/Technolas Perfect Vision, Munich, Germany). Patients were also randomly divided into three subgroups to compare the effect of three different small inner ring diameters (1.8/2.0/2.2 mm (Groups A/B/C)). Follow-up examinations were performed at 1, 3, 6, 12, 24 and 36 months, and included near and distance visual acuity tests, slit-lamp examinations and corneal topography. Results Median uncorrected near visual acuity (UNVA) increased from 0.7/0.7/0.7 logMAR (Groups A/B/C) to −0.1/0.1/0.1 logMAR 36 months after surgery. Uncorrected distance visual acuity changed slightly from 0.1/0.2/0.1 logMAR to 0.2/0.3/0.1 logMAR. Losses of two lines of binocular corrected distance visual acuity (CDVA) were noted in 0/25/0% of eyes. Median spherical equivalent changed from 0.75/0.75/0.75 dioptres to −0.19/0.13/−0.19 dioptres. Overall patient satisfaction with the procedure was 80%. Conclusions INTRACOR with a modified pattern improved UNVA in all patients over a 36-month follow-up period. The possibility of reduced CDVA underlines the need for careful patient selection. Trial registration number NCT00928122.

Long-term outcomes of intrastromal femtosecond laser presbyopia correction: 3-year results

Background/aims To analyse visual outcomes and corneal changes 3 years after intrastromal femtosecond laser presbyopia treatment. Methods In a prospective, unicentric clinical trial, 25 presbyopic patients received INTRACOR treatment (Technolas femtosecond laser) on their non-dominant eye. Examinations were performed preoperatively as well as 1, 24 and 36 months postoperatively and included refraction, near, intermediate and distance visual acuity tests, reading speed, corneal topography, stray light measurement, endothelial cell count and slit-lamp examination. Results Comparison of preoperative versus 36 months postoperative values showed in median an improvement of uncorrected near visual acuity (UNVA) from 0.70 logMAR to 0.10 logMAR (p<0.001). Corrected distance visual acuity (CDVA) was reduced from −0.10 logMAR to 0.00 logMAR (p<0.001). The spherical equivalent preoperatively was 0.625 D and after an initial myopic shift after 1 month (0.125 D) and 24 months (0.25 D), the 36 months value (0.50 D) returned to resemble the preoperative value in statistical terms (p=0.123). A significant corneal steepening of 1.50 D in the treated area was measured. Pachymetry (thinnest point) revealed a statistically significant, but clinically insignificant corneal thickening from 535 to 549 µm (p=0.033). Endothelial cell count did not change. 92.86% of patients felt comfortable with the surgery result. Conclusion INTRACOR treatment after 36 months improved UNVA to varying degrees. The effect can be explained by a corneal steepening. An initial myopic shift was reversible. Reductions especially in CDVA have to be taken into account and therefore careful patient selection and information is obligatory. Trial registration number NCT01164358 and NCT01025050, Results

RESPONDER – diagnosis of pathological complete response by vacuum-assisted biopsy after neoadjuvant chemotherapy in breast Cancer - a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial

BackgroundNeoadjuvant chemotherapy (NACT) is a standard approach of the multidisciplinary treatment of breast cancer. Depending on the biological subtype a pathological complete response in the breast (bpCR) can be achieved in up to 60% of the patients. However, only limited accuracy can be reached when using imaging for prediction of bpCR prior to surgery. Due to this diagnostic uncertainty, surgery after NACT is considered to be obligatory for all patients in order to either completely remove residual disease or to diagnose a bpCR histologically. The purpose of this trial is to evaluate the accuracy of a vacuum-assisted biopsy (VAB) to diagnose a bpCR after NACT prior to surgery.MethodsThis study is a multicenter, confirmative, one-armed, intra-individually-controlled, open, diagnostic trial. The study will take place at 21 trial sites in Germany. Six hundred female patients with breast cancer after completed NACT showing at least a partial response to NACT treatment will be enrolled. A vacuum-assisted biopsy (VAB) guided either by ultrasound or mammography will be performed followed by histopathological evaluation of the VAB specimen before standard, guideline-adherent breast surgery. The study is designed to prove that the false negative rate of the VAB is below 10%.DiscussionAs a bpCR is becoming a more frequent result after NACT, the question arises whether breast surgery is therapeutically necessary in such cases. To study this subject further, it will be crucial to develop a reliable test to diagnose a bpCR without surgery.During the study we anticipate possible problems in patient recruitment as the VAB intervention does not provide participating patients with any personal benefit. Hence, a proficient informed consent discussion with the patient and a detailed explanation of the study aim will be crucial for patient recruitment. Another critical issue is the histopathological VAB evaluation of a non-tumorous specimen as this may have been taken either from the former tumor region (bpCR) or outside of the (former) tumor region (non-representative VAB, sampling error).Trial registrationThe trial has been registered at clinicaltrials.gov with the identifier NCT02948764 on October 28, 2016 and at the German Clinical Trials Register (DRKS00011761) on February 20, 2017. The date of enrolment of the first participant to the trial was on March 8, 2017.

Influence on intraocular lens power calculation of corneal radii measurement using an image-guided system

Purpose To analyze the influence on intraocular lens (IOL) power calculation of corneal radii measured by the Verion Image‐Guided System in comparison with those measured by partial coherence interferometry (PCI) (IOLMaster) and optical low‐coherence reflectometry (OLCR) (Lenstar) systems. Setting International Vision Correction Research Centre, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany. Design Prospective case series. Methods One eye of ophthalmologically healthy volunteers was examined with the image‐guided, PCI, and OLCR systems. Corneal radii could be measured with all 3 devices; axial length (AL) and anterior chamber depth (ACD) could be measured with PCI and OLCR only. The IOL power calculations for the Acrysof SN60WF IOL using 4 formulas were compared between the image‐guided system and both the PCI device and OLCR device. For IOL calculation with the image‐guided system, the AL and ACD of the device used for comparison were applied. Results Of the 150 volunteers, 136 (mean age 39.60 years ± 17.31 [SD]) had valid measurements with all 3 devices and were included in the analysis. Compared with PCI, the image‐guided system measured statistically significant larger values for corneal radii and IOL power calculations for all 4 formulas. There were no statistically significant differences between the image‐guided system and the OLCR device. In both groups, the surgeon would have chosen the same IOL power in approximately 60% to 65% of cases and a ±0.5 diopter different IOL power in approximately 30% to 35% of cases when using the image‐guided system. Conclusions The IOL power calculation using the image‐guided system showed statistically significant differences compared with the PCI device but not when compared with the OLCR device. The clinical relevance of this theoretical approach remains to be evaluated. Financial Disclosure Drs. Auffarth and Holzer received travel grants and lecture fees from Alcon Pharma GmbH and Carl Zeiss Meditec AG.