Quality Assurance in Cataract and Lens Surgery with Special Consideration of Subjective Patient Reported Outcome Measures and Clinical Reported Outcome Measures. / Qualitätssicherungen in der Katarakt- und Linsenchirurgie unter besonderer Berücksichtigung der subjektiven Patientenbeurteilung und der refraktiven Ergebnisse.

BACKGROUND: Results of medical interventions must be documented and evaluated. In studies, this is done with clinical outcomes data (clinician/clinical reported outcome measure, CROM). In the past, less weight has been given to patient surveys with questionnaires (patient reported outcome measure, PROM). PATIENTS/MATERIALS AND METHODS: This retrospective study included 104 eyes from 53 patients. Of these, 35 patients had cataract surgery and 15 patients had a refractive lens exchange. The implanted lenses included 62 trifocal IOLs (Asphina trifiocal 839, Zeiss), 34 trifocal toric IOLs (Asphina trifocal toric 939, Zeiss) and 8 bifocal IOLs (Asphina 808, Zeiss) with the same IOL platform. Patients completed a modified questionnaire before surgery and one year after surgery. We made changes to the CatQuest-9SF questionnaire so as to also document side effects. RESULTS: The effort required by the patients to answer the questionnaire was a burden. Transcribing the data into electronic files so as they could be saved and analyzed was a lot of work for the staff. Among the patients, 88.7% were spectacle-independent in everyday life, and 77.5% for reading. 44.4% had a halo problem. 92% reported the operation as a success. 100% had a prediction error of ≤ ± 0.75 dpt. CONCLUSION: There is a high rate of patient satisfaction with the outcome of the intervention. New questionnaires are needed for new IOLs. The Catquest-9SF is from 2009. Accordingly, revisions and new validation is necessary. Beyond that, only automatic data transfer will reduce the amount of work involved in data input.

Considerations on the Castrop formula for calculation of intraocular lens power.

BACKGROUND: To explain the concept of the Castrop lens power calculation formula and show the application and results from a large dataset compared to classical formulae. METHODS: The Castrop vergence formula is based on a pseudophakic model eye with 4 refractive surfaces. This was compared against the SRKT, Hoffer-Q, Holladay1, simplified Haigis with 1 optimized constant and Haigis formula with 3 optimized constants. A large dataset of preoperative biometric values, lens power data and postoperative refraction data was split into training and test sets. The training data were used for formula constant optimization, and the test data for cross-validation. Constant optimization was performed for all formulae using nonlinear optimization, minimising root mean squared prediction error. RESULTS: The constants for all formulae were derived with the Levenberg-Marquardt algorithm. Applying these constants to the test data, the Castrop formula showed a slightly better performance compared to the classical formulae in terms of prediction error and absolute prediction error. Using the Castrop formula, the standard deviation of the prediction error was lowest at 0.45 dpt, and 95% of all eyes in the test data were within the limit of 0.9 dpt of prediction error. CONCLUSION: The calculation concept of the Castrop formula and one potential option for optimization of the 3 Castrop formula constants (C, H, and R) are presented. In a large dataset of 1452 data points the performance of the Castrop formula was slightly superior to the respective results of the classical formulae such as SRKT, Hoffer-Q, Holladay1 or Haigis.

[Back-calculation of the keratometer index-Which value would have been correct in cataract surgery?] / Rückrechnung des Keratometerindex ­ Welcher Wert wäre bei der Kataraktchirurgie richtig gewesen?

BACKGROUND AND PURPOSE: In the clinical routine the conversion of corneal radii into corneal refractive power using a keratometer index is rarely discussed. The purpose of this study was to back-calculate the keratometer index in pseudophakic eyes based on the refractive power of the lens, biometric measurements and refraction, and to compare it to clinically established values. PATIENTS AND METHODS: In this retrospective case series 99 eyes of 99 patients without pathological alterations, previous diseases, comorbidities or history of ocular surgery apart from the uneventful cataract surgery were enrolled. In all eyes a CT Asphina 409M(P) (Carl-Zeiss Meditec, Berlin, Germany) had been implanted by two surgeons (EF and PE). For calculation we used shape and power data of the intraocular lens and data from optical biometry (axial length, pseudophakic anterior chamber depth, lens thickness, corneal radius; IOLMaster 700, Carl-Zeiss Meditec, Jena, Germany). The refraction was derived manually with a trial frame (measurement distance 5 m) and autorefractometry (iProfiler, Carl-Zeiss, Jena, Germany). For this three model eyes were used: a thin lens with the nominal refractive power positioned in the equatorial plane (model A) or in the secondary principal plane of the thick lens (model B) as well as a model considering the intraocular lens as a thick lens located at its measured position (model C). RESULTS: Back-calculation of the keratometer index using vergence formulas resulted in a keratometer index based on subjective refraction measurements considering lane distance correction of 1.3307 ± 0.0026/1.3312 ± 0.0026/1.332 ± 0.0027 for model A/model B/model C, respectively. Based on objective refraction measurements (autorefraction calibrated to infinity object distances) resulted in a keratometer index of 1.3301 ± 0.0021/1.3306 ± 0.0021/1.3315 ± 0.0021, for model A/model B/model C, respectively. The keratometer index did not show any trend in linear regression for axial length or corneal radius for any of the three models or for any refraction method. CONCLUSION: The keratometer index derived from back-calculation matched with the Zeiss index (1.332) but was much lower compared to other established indexes, e.g. the Javal index (1.3375). The missing trend for axial length or corneal radius implies that simple vergence formulas for intraocular lens refractive power calculation without correction terms or fudge factors perform best with a keratometer index slightly below 1.332, if the biometrically measured position of the intraocular lens is used as the effective lens position.

Prediction Accuracy of Total Keratometry Compared to Standard Keratometry Using Different Intraocular Lens Power Formulas.

PURPOSE: To compare the accuracy of intraocular lens (IOL) power calculation based on standard keratometry (K) and the new Total Keratometry (TK). METHODS: A post-hoc analysis of study data based on 145 pseudophakic astigmatic eyes was conducted. The absolute prediction error (APE) of spherical equivalent (SE) and cylinder (CYL) was calculated based on K and TK (including posterior corneal surface) data recorded 6 weeks after IOL implantation. APE was calculated as the difference between the postoperative refraction and the refractive error predicted by three classic IOL calculation methods (Haigis/Haigis-T, Barrett Universal II, Barrett Toric Calculator) and two new formulas developed for TK (Barrett TK Universal II, Barrett TK Toric). For APE in SE, the Haigis-T (K versus TK) and Barrett Universal II (K) versus Barrett TK Universal II (TK) were compared. For APE in CYL, the Haigis-T (K versus TK) and Barrett Toric Calculator (K) versus Barrett TK Toric formula (TK) were compared. RESULTS: Mean APE in SE and CYL was lower based on TK values compared to K, with a mean APE difference (K - TK) of 0.011 ± 0.107 diopters (D) (SE Haigis-T; 95% confidence interval [CI]: -0.004 to infinity), 0.016 ± 0.113 D (SE: Barrett Universal II versus Barrett TK Universal II; 95% CI: 0.0005 to infinity), 0.103 ± 0.173 D (CYL: Haigis-T; 95% CI: 0.0791 to infinity), and 0.020 ± 0.148 D (CYL: Barrett Toric versus Barrett TK Toric; 95% CI: -0.0002 to infinity). APE in SE was within ±0.50 D in 86% (Barrett TK Universal II) versus 84% (Barrett Universal II) of eyes. APE in CYL was within ±0.50 D in 58% (Haigis from TK) versus 44% (Haigis from K) of eyes. CONCLUSIONS: In comparison to standard K, a higher prediction accuracy can be expected by using TK values along with the two newly developed formulas. TK values are compatible with standard IOL power calculation formulas and existing optimized IOL constants. [J Refract Surg. 2019;35(6):362-368.].

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.

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.

Perioperative cataract OP management by means of teleconsultation.

BACKGROUND: Teleconsultation services have the potential to improve the communication among different medical care providers and between them and the patient. Increasing effectiveness in the shape of a savings in time or cost is often the result of better communication. METHODS: A study was performed in order to demonstrate the feasibility of teleconsultation services, using the perioperative management of cataract patients as an example, and to provide data on the quality, acceptance and effectiveness of these services in comparison with a control group experiencing normal treatment. RESULTS: Over a period of 3 months 42 patients of the teleconsultation group and 20 controls were studied. There were two referring ophthalmologists and three surgeons. The teleconsultation group had one consultation fewer with the ophthalmic surgeon because of the teleconsultation service. Patient satisfaction was slightly higher using the new technology. Patients would like to see this technique used again should surgery on the second eye become necessary. CONCLUSIONS: Teleconsultation services are ready to support and improve perioperative cataract management. Patients' confidence in their medical treatment was increased by using teleconsultation services. Physicians will expand the use of teleconsultation.