Early findings in a randomised controlled trial on crosslinking protocols using isoosmolar and hypoosmolar riboflavin for the treatment of progressive keratoconus.

PURPOSE: To present baseline characteristics and to present the perioperative corneal thickness during corneal crosslinking (CXL) treatment for progressive keratoconus and to describe how the addition of sterile water (SW) efficaciously can maintain the corneal thickness. The treatment efficacy will be evaluated when the 1-year follow-up is complete. METHODS: A randomised clinical study using epithelium-off CXL with continuous UVA irradiation (9 mW/cm2) and two kinds of riboflavin solutions: (i) isoosmolar dextran-based riboflavin (n = 27) and (ii) hypoosmolar dextran-free riboflavin (n = 27). INCLUSION CRITERIA: progressive keratoconus with an increase in maximum keratometry value (Kmax) of 1.0 dioptre (12 months) or 0.5 dioptres (6 months). Corneae thinner than 400 µm were also included. OUTCOME PARAMETERS: Perioperative corneal thickness and the effect of adding SW. RESULTS: Seventy-four per cent of the patients in the isoosmolar group and 15% in the hypoosmolar group required the addition of SW, which effectively maintained a corneal thickness of 400 µm in all cases during CXL. The addition of SW was primarily needed during the irradiation procedure and not the preoperative soaking period. CONCLUSIONS: Especially during the CXL irradiation phase, isoosmolar riboflavin causes a significant dehydrating effect leading to corneal thinning during CXL. The customised addition of SW is efficacious in maintaining the corneal thickness during CXL and could increase the safety of the procedure.

Intraocular pressure-related side-effects after endothelial keratoplasty.

PURPOSE: To investigate circumpapillary retinal nerve fibre layer (RNFL) thickness, pupillary function and diameter after phacoemulsification and lens implantation alone or combined with endothelial keratoplasty (EK). METHODS: This study was a secondary analysis of data from a randomized, single-masked trial, that included 72 patients with Fuchs' endothelial dystrophy and cataract, equally allocated (1:1) to ultrathin Descemet's stripping automated endothelial keratoplasty or Descemet's membrane endothelial keratoplasty. The cataract extraction (CE) group included 40 patients undergoing cataract surgery only. All patients were treated with phacoemulsification and lens implantation. RESULTS: RNFL thickness was significantly lower in the CE group than after EK for the global (p < 0.01), nasal (p = 0.04), and temporal sectors (p = 0.01) 12 months after surgery. RNFL thickness was comparable between patients treated with rebubbling and others (p ≥ 0.16 for all comparisons) after 12 months. The CE group and patients treated with EK demonstrated a comparable scotopic (p = 0.34) and photopic pupil diameter (p = 0.95) as well as a comparable maximum (p = 0.83) and average pupillary constriction velocity (p = 0.95) after 12 months. In contrast, patients treated with rebubbling had a significantly smaller scotopic pupil diameter (p = 0.04). CONCLUSION: In this study, no evidence was found indicating a negative impact on the RNFL thickness after EK when compared to CE 12 months after surgery. Iris function and pupil diameter were comparable between the CE group and patients treated with EK after 12 months.

Corneal grafting.

Corneal grafting is performed approximately 650 times a year in Denmark. A summary of these procedures is given in this review. Fuchs' endothelial dystrophy and pseudophakic bullous keratopathy are frequent indications for transplantation. Previously, penetrating keratoplasty was the technique of choice but is nowadays mainly used for combined stromal and endothelial pathology. Instead, techniques specifically replacing diseased layers are more common. The Danish Cornea Bank is the only center in Denmark which undertakes preparation and distribution of tissue. The operative procedures are performed at Aarhus University Hospital or Rigshospitalet Glostrup.

Early findings in a prospective randomised study on three cross-linking treatment protocols: interruption of the iontophoresis treatment protocol.

PURPOSE: To present the outcome of the interrupted iontophoresis-assisted treatment arm in an ongoing randomised clinical trial (NCT04427956). METHODS: A randomised clinical study of corneal cross-linking (CXL) using continuous UV-A irradiation at a rate of 9 mW/cm2 and three different types of riboflavin and riboflavin delivery mode: (1) iso-osmolar dextran-based riboflavin (epithelium-off), (2) hypo-osmolar dextran-free riboflavin (epithelium-off) and (3) iontophoresis-assisted delivery of riboflavin (epithelium-on) for the treatment of progressive keratoconus. Inclusion criteria were an increase in the maximum keratometry value (Kmax) of 1.0 dioptre over 12 months or 0.5 dioptre over 6 months. The primary outcome in evaluating treatment efficacy was Kmax. Recently presented stratified detection limits were used post hoc to confirm the enrolment of patients with truly progressive keratoconus and in the assessment of the need for re-CXL. RESULTS: Thirteen patients had been randomised to iontophoresis-assisted CXL when the treatment arm was interrupted; two patients dropped out. Of the remaining 11 patients, 7 were deemed as having truly progressive disease according to the more recent stratified detection limits. The disease continued to progress in three patients according to the original definition (increase in Kmax≥1 D), necessitating re-CXL with epithelium-off CXL. This progression was confirmed by post hoc analysis using the stratified detection limits for progression. CONCLUSIONS: The iontophoresis-assisted CXL protocol failed to halt further disease progression in 27% of the patients. The failure rate increased to 38% when considering only the patients deemed to have truly progressive disease using the stratified detection limits.

Visual function after ultrathin Descemet's stripping automated endothelial keratoplasty or Descemet's membrane endothelial keratoplasty combined with cataract surgery: a randomised controlled clinical trial.

AIMS: To compare best-corrected visual acuity (BCVA), contrast sensitivity and endothelial cell density (ECD) after ultrathin Descemet's stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet's membrane endothelial keratoplasty (DMEK). METHODS: A randomised, single-blinded, single-centre design was used. 72 patients with Fuchs' endothelial dystrophy and cataract were randomised to UT-DSAEK or DMEK combined with phacoemulsification and lens implantation. 27 patients with cataract were included in a control group and treated with phacoemulsification and lens implantation. The primary outcome was BCVA at 12 months. RESULTS: Compared with UT-DSAEK, DMEK resulted in better BCVA with mean differences of 6.1 early treatment diabetic retinopathy study (ETDRS) (p=0.001) after 3 months, 7.4 ETDRS (p<0.001) after 6 months and 5.7 ETDRS (p<0.001) after 12 months. The control group obtained significantly better BCVA with a mean difference of 5.2 ETDRS (p<0.001) compared with DMEK 12 months postoperatively. Compared with UT-DSAEK, contrast sensitivity was significantly better 3 months after DMEK with a mean difference of 0.10 LogCS (p=0.03). However, our study found no effect after 12 months (p=0.08). ECD was significantly lower after UT-DSAEK compared with DMEK with mean differences of 332 cells/mm2 (p<0.01) after 3 months, 296 cells/mm2 (p<0.01) after 6 months and 227 cells/mm2 (p=0.03) after 12 months. CONCLUSIONS: Compared with UT-DSAEK, DMEK resulted in better BCVA 3, 6 and 12 months postoperatively. Twelve months postoperatively, DMEK had a higher ECD than UT-DSAEK; however, no difference in contrast sensitivity was found. TRIAL REGISTRATION NUMBER: NCT04417959.

Patient experience and repeatability of measurements made with the Pentacam HR in patients with keratoconus.

BACKGROUND: To investigate whether the repeatability of measurements with the Pentacam HR in patients with keratoconus is improved by patients gaining more experience of the measurement situation. Such an improvement could enhance the accuracy with which progressive keratoconus can be detected. METHODS: Four replicate measurements were performed on Day 0 and on Day 3. Parameters commonly used in the diagnosis of progressive keratoconus were included in the analysis, namely the flattest central keratometry value (K1), the steepest central keratometry value (K2), the maximum keratometry value (Kmax), and the parameters A, B and C from the Belin ABCD Progression Display. In addition, quality parameters used by the Pentacam HR to assess the quality of the measurements were included, namely the analysed area (front + back), 3D (front + back), XY, Z, and eye movements. RESULTS: Neither the diagnostic parameters nor the quality parameters showed any statistically significant improvement on Day 3 compared to Day 0. The quality parameter "eye movements" deteriorated significantly with increasing Kmax. CONCLUSION: Gaining experience of the measurement situation did not increase the accuracy of the measurements. Further investigations should be performed to determine whether the increasing number of eye movements with increasing disease severity has a negative effect on the repeatability of the measurements.

The intra- and inter-day repeatability of corneal densitometry measurements in subjects with keratoconus and in healthy controls.

The healthy cornea is transparent, however, disease can affect its structure, rendering it more or less opaque. The ability to assess the clarity of the cornea objectively could thus be of considerable interest for keratoconus patients. It has previously been suggested that densitometry can be used to diagnose early keratoconus, and that the values of densitometry variables increase with increasing disease severity, indicating that densitometry could also be used to assess progressive keratoconus. Previous studies have only assessed the repeatability of corneal densitometry measurements on the same day, which does not reflect the clinical setting in which changes are evaluated over time. We have therefore evaluated the inter-day repeatability of densitometry measurements in both patients with keratoconus and healthy controls. Measurements in the middle layer of the 2-6 mm zone of the cornea showed the best repeatability. Although an objective measure of the corneal transparency could be interesting, the generally poor repeatability of densitometry measurements limits their use. The repeatability of corneal clarity measurements could be improved by using other approaches such as optical coherence tomography, but this remains to be investigated. Such improvements would allow the more widespread use of corneal densitometry in clinical practice.

Macular Thickness After Ultrathin Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty Combined With Cataract Surgery: A Randomized Controlled Clinical Trial.

PURPOSE: The aim was to investigate alterations in central retinal thickness (CRT) and their implications for visual acuity after ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) combined with cataract surgery. METHODS: A total of 72 eyes of 72 patients with Fuchs endothelial dystrophy and cataract were included and equally randomized to either UT-DSAEK or DMEK. A control group of 40 eyes of 40 patients with cataract were included for cataract surgery. All participants were examined preoperatively as well as 3 and 6 months postoperatively. RESULTS: There was no significant difference in CRT between the study groups after surgery ( P = 0.896). A significant difference in best-corrected visual acuity (BCVA) progression over time was found between the study groups ( P < 0.0001). Average improvements of 8.03 EDTRS after UT-DSAEK ( P < 0.001) and 16.77 EDTRS after DMEK ( P < 0.001) were found 6 months postoperatively. No significant correlation was found between the change in BCVA and CRT from baseline to 3 months postoperatively (r 2 < 0.0001, P = 0.96) and from baseline to 6 months postoperatively (r 2 = 0.0053, P = 0.46). CONCLUSIONS: CRT was not altered by UT-DSAEK, DMEK, or cataract surgery 3 and 6 months postoperatively. BCVA significantly improved 3 and 6 months after UT-DSAEK and DMEK, respectively. No significant correlations were found between the change in BCVA and CRT postoperatively. As such CRT alterations were comparable after UT-DSAEK, DMEK, and cataract surgery.

Current clinical practice in corneal crosslinking for treatment of progressive keratoconus in four Nordic countries.

PURPOSE: To evaluate clinical practice in the diagnosis and treatment of progressive keratoconus with corneal crosslinking (CXL) in four Nordic countries. METHODS: A questionnaire was sent to all centres at which keratoconus patients are evaluated and CXL is performed in Sweden, Denmark, Norway and Iceland. Nineteen of 20 centres participated. RESULTS: CXL is performed approximately 1300 times per year in these four Nordic countries with a population of around 21.7 million (2019). In most cases, progression is evaluated using the Pentacam HR, and the maximum keratometry reading (Kmax ) is considered the most important parameter. The most frequently used treatment protocol in Scandinavia is the 9 mW/cm2 epi-off protocol, using hydroxylpropyl methylcellulose riboflavin (HPMC-riboflavin). The participants deemed the following areas to be in most need of improvement: adaptation of the CXL protocol to individual patients (5/19), the development of effective epi-on treatment protocols (4/19), optimal performance of CXL in thin corneas (4/19), improvement of the definition of progression (2/19), and diagnosis of the need for re-treatment (2/19). CONCLUSIONS: We concluded that the diagnosis of progressive keratoconus and the diagnostic equipment used are similar. Treatment strategies are also similar but are suitably different to provide an interesting basis for the comparison of treatment outcomes. The high degree of participation in this survey indicates the possibility of future scientific collaboration on CXL focusing on the areas deemed to need improvement. It would also be of interest to evaluate the possibility of creating a Nordic CXL Registry. The high number of CXL treatments performed ensures sufficient statistical power to solve many questions. Such a registry could be an important contribution to evidence-based care and would allow for longitudinal evaluation.

Influence of time to procurement, incubation and release of organ cultured donor corneas on graft failure after Descemet Stripping Automated Endothelial Keratoplasty.

PURPOSE: The aim of the present study was to investigate whether the time from death to procurement, to preservation or the storage time of donor corneas preserved in organ culture influenced the clinical outcome of patients undergoing Descemet stripping automated endothelial keratoplasty (DSAEK) for Fuchs endothelial keratoplasty. METHODS: We conducted a registry-based study on 776 patients undergoing DSAEK. Data on time from donor death to cornea retrieval (DRT), time from death to preservation (DPT), the preservation time and donor cornea characteristics: age, sex and endothelial cell density (ECD) at the time of release for surgery, were extracted from The Danish Cornea Bank Registry. Data on recipient follow-up were collected from a corneal graft registry. The primary outcome was presence of graft failure within a period from 2 months to 2 years after surgery. Secondary outcomes were DRT, DPT, ECD ≤2300 and gender mismatch between donor and recipient. RESULTS: Graft failure occurred in 26 patients. The mean preservation time for failed grafts was 34.1 ± 10.0 days (mean ± SD) and 27.3 ± 10.6 days (mean ± SD) for the clear, functional grafts at the 2-year follow-up. A preservation time of >29 days compared with ≤29 days was associated with a lower survival (HR 2.33, 95% CI on 1.06-5.14, p = 0.036) and an increased risk of graft failure (RR 1.53, 95% CI on 1.11-2.10, p = 0.009). For the secondary outcome variables, no difference in the risk of graft failure was observed and did not appear to impact the survival rate of DSAEK patients. CONCLUSION: Preservation time of donor cornea was associated with graft survival and a prolonged preservation time of more than 4 weeks seemed to lower the 2-year survival.

The importance of donor characteristics, post-mortem time and preservation time for use and efficacy of donated corneas for posterior lamellar keratoplasty.

PURPOSE: The aim of this study is to examine whether donor age, death-to-retrieval time (DRT) and death-to-preservation time (DPT) as well as total preservation time affect donor cornea suitability for endothelial keratoplasty (EK) or penetrating keratoplasty (PK). METHODS: A registry-based study was performed identifying 3248 corneas donated between 2011 and 2017. Data regarding donated corneas were extracted from The Danish Cornea Bank and donor medical records and evaluated for missing information. The primary outcome was whether ECD at preservation (ECD-P) or at release (ECD-R) was >2000 cells/mm2 . RESULTS: Logistic regression for ECD-P showed a significant negative effect of increasing age (OR: 1.07, 95%CI: 1.05;1.08, p < 0.001) on donor suitability. Higher ECD-P had a significant positive effect on graft eligibility (OR: 1.007 95%CI: 1.003;1.010, p < 0.001). No significant effect of donor sex (p = 0.547), DRT (p = 0.289) or DPT (p = 0.102) on donor suitability for EK or PK (Chi-squared test). CONCLUSION: High donor age and low ECD-P negatively affect the suitability of donor corneas for EK/PK whereas DRT and DPT did not affect graft suitability.

7-Year Results of SMILE for High Myopia: Visual and Refractive Outcomes and Aberrations.

PURPOSE: To evaluate the 7-year visual, refractive, and optical outcomes following small incision lenticule extraction (SMILE) for high myopia and myopic astigmatism. METHODS: Sixty-nine eyes (69 patients) undergoing SMILE between March 2011 and January 2012 at Aarhus University Hospital were included. Preoperative, 3-month, 3-year, and 7-year evaluation included: manifest refraction and uncorrected (UDVA) and corrected (CDVA) distance visual acuities, total corneal refractive power (TCRP), average keratometry (Km), aberrations, and central corneal thickness (CCT). RESULTS: Preoperative spherical equivalent averaged -7.53 ± 1.18 diopters (D). Twenty-seven eyes were targeted emmetropia. In the emmetropic eyes, the postoperative logMAR UDVA remained stable (P = .11). When including all eyes, UDVA became worse from 3 to 7 years (3 months: 0.050 ± 0.16 logMAR; 3 years: 0.044 ± 0.21 logMAR; 7 years: 0.131 ± 0.29 logMAR; P < .027), whereas CDVA remained stable (3 months: -0.07 ± 0.09 logMAR; 3 years: -0.09 ± 0.08 logMAR; 7 years: -0.09 ± 0.08 logMAR, P > .99). At 7 years, 59.4% and 81.2% were within ±0.50 and ±1.00 D of target refraction, respectively. Average refractive regression was significant from 3 months to 7 years (-0.34 ± 0.69 D) and from 3 to 7 years (-0.25 ± 0.41 D, P < .05). After exclusion of three outliers with high myopic correction (< 9.63 D) and considerable regression (<-1.50 D), the average regression over 7 years was -0.25 ± 0.49 D (P = .004) with no significant change from 3 to 7 years (P = .069). Average CCT, TCRP, and anterior Km significantly increased (P < .001), whereas the posterior Km and total corneal aberrations remained stable (P > .092). CONCLUSIONS: The long-term visual outcome remained stable after SMILE, but with an average regression of -0.34 D over 7 years. A minor group with high myopic correction exhibited considerable refractive regression years after SMILE. [J Refract Surg. 2021;37(10):654-661.].

An inter-day assessment of the ABC parameters in the evaluation of progressive keratoconus.

The progression of keratoconus is commonly determined by comparing the results of corneal tomographic measurements on different occasions. However, investigations on the repeatability of measurements are commonly performed within the same day, thus not taking the inter-day variation into account. The effect of keratoconus disease severity on the measurement error is also seldom considered. In this post hoc investigation, the parameters A, B and C in the Belin ABCD Progression Display were evaluated in relation to disease severity in intra-day and inter-day measurements. Four consecutive measurements were performed on 61 patients with keratoconus on the same day (intra-day). In another cohort, four consecutive measurements were obtained and then repeated 3 days later in 25 patients with keratoconus and 25 healthy controls (inter-day). The results suggest that the diagnosis of disease progression would benefit from inter-day measurements, and the stratification of the parameters A and C according to disease severity. It is also recommended that tomographic systems such as the Pentacam HR be modified to allow the comparison of both single measurements and the mean of replicate measurements of the parameters used in the assessment of progression of keratoconus.

Iris epithelium detachment - An uncommon complication of Nd:YAG laser capsulotomy.

PURPOSE: To report a case of iris epithelium detachment following Nd:YAG laser capsulotomy. OBSERVATIONS: We describe the case of an 81 year old woman who developed hyphema and detachment of the iris epithelium following standard Nd:YAG laser capsulotomy. The detachment was readily visualized using anterior segment OCT. The hyphema was managed with topical atropine and steroids. The detachment itself was left untreated. CONCLUSIONS AND IMPORTANCE: No persisting subjective complaints or effect on visual function were noted. To our knowledge, this complication represents a novel observation.

The Interday Repeatability of Parameters for the Assessment of Progressive Disease in Subjects With Less Advanced Keratoconus.

PURPOSE: To evaluate the interday repeatability in the measurement of parameters used for the detection of progression of keratoconus by prediction limits (PL) for single measurements, and the repeatability coefficient (RC) for the mean of replicate measurements. DESIGN: Prospective reliability analysis for cases and control eyes. METHODS: Twenty-five eyes in 25 subjects with KC and 25 eyes in 25 healthy controls were included. Four consecutive measurements were made, 3 days apart, with a Pentacam HR tomographic instrument (denoted the Pentacam) and a Nidek ARK 560-A auto-keratometer (denoted the keratometer). Main outcome measures were the intra- and interday RC of parameters used in the detection of progression of keratoconus. RESULTS: The most repeatable parameter obtained with the Pentacam was the curvature power of the central flat meridian (K1, 0.44 D [RC], -0.55 to 0.60 diopter [D] [PL]), followed by the central steep meridian (K2, 0.72 D [RC], -0.90 to 0.94 D [PL]). The interday repeatability of K1 and K2 was similar when using the keratometer (K1, 0.32 D [RC], -0.66 to 0.57 D [PL], K2, 0.93 D [RC], -1.36 to 1.08 D [PL]). The interday repeatability of the curvature power of the steepest point (Kmax, 0.84 D [RC], -0.90 to 1.11 D [PL]) would benefit from being stratified: RC = 0.44 D and PL = -0.49 to 0.67 D for Kmax < 49.0 D, and RC = 1.08 D and PL = -1.19 to 1.42 D for Kmax ≥ 49.0 D. CONCLUSIONS: The interday repeatability of measurements, single or replicate, in subjects with keratoconus should be considered when diagnosing progressive disease. K1 exhibited the best intraday repeatability. Kmax benefits from being stratified according to disease severity.

Impact on binocular visual function of small-incision lenticule extraction for high myopia.

PURPOSE: To assess whether small-incision lenticule extraction (SMILE) for high myopia reduces the binocular visual function assessed by stereoacuity, binocular visual acuity, binocular contrast sensitivity, and binocular summation. SETTING: University hospital. DESIGN: Prospective case series. METHODS: Patients with a myopic spherical equivalent of at least 6.00 diopters (D) scheduled for SMILE aimed at emmetropia were included. Psychophysical testing was performed with correction preoperatively but no correction postoperatively. Stereoacuity was assessed with the Randot Circles test and the near Frisby test, visual acuity (monocular and binocular) was assessed with high-contrast Early Treatment Diabetic Retinopathy Study charts, and contrast sensitivity (monocular and binocular) was assessed with the Pelli-Robson chart and the Freiburg Acuity and Contrast Test. Binocular summation was calculated by comparing the binocular score against the best monocular score. RESULTS: A total of 138 eyes of 69 patients were included. The mean spherical equivalent changed from -7.46 D ± 1.06 (SD) to -0.23 D ± 0.40 postoperatively. Stereoacuity did not change significantly postoperatively; median change (interquartile range) was -0.32 (-6.21 to 1.55) seconds of arc with the Frisby test and 0.00 (-7.5 to 5.0) seconds of arc with the Randot test (P ≥ .06). Binocular postoperative uncorrected distance visual acuity was not different from the preoperative corrected distance visual acuity (P = .40). Contrast sensitivity declined slightly monocularly with both tests of contrast sensitivity but was unaltered binocularly (P ≥ .08). Binocular summation for visual acuity and contrast sensitivity was unaltered following surgery (P ≥ .09). CONCLUSIONS: SMILE for high myopia did not reduce the binocular function assessed by stereoacuity, binocular visual acuity, binocular contrast sensitivity, and binocular summation.

Visual image quality after small-incision lenticule extraction compared with that of spectacles and contact lenses.

PURPOSE: To assess the influence of small-incision lenticule extraction (SMILE) for high myopia on the visual image quality assessed by the logarithm of the visual Strehl ratio (logVSX) and put this into a clinical context by pairwise comparing the logVSX of postoperative eyes with those of myopic controls wearing spectacles and/or contact lenses. SETTING: University hospital. DESIGN: Prospective and cross-sectional clinical study. METHODS: Patients with a myopic spherical equivalent of at least 6.00 diopters treated with SMILE aimed at emmetropia and correspondingly myopic controls corrected with spectacles and/or contact lenses were included. The logVSX calculation was divided into habitual logVSX based on the wavefront aberration measurement directly and optimal logVSX calculated in a theoretical through-focus experiment to obtain the best-achievable logVSX. RESULTS: A total of 117 eyes of 61 patients and 64 eyes of 34 myopic controls were included. SMILE did not affect the habitual logVSX but worsened the optimal logVSX (P < .001). The postoperative habitual logVSX was statistically significantly worse compared with contact lenses (P = .002). The postoperative optimal logVSX was significantly worse compared with both spectacles (P < .01) and contact lenses (P = .003). There was no statistically significant difference in habitual or optimal logVSX between spectacles and contact lenses. CONCLUSIONS: SMILE for high myopia does not affect the habitual logVSX but decreases the optimal logVSX slightly. The postoperative habitual logVSX is worse than for contact lenses but not spectacles, and the postoperative optimal logVSX is worse than for both contact lenses and spectacles. There is no statistically significant difference in either habitual or optimal logVSX between spectacles and contact lenses.

The Keratoconus Outcome Research Questionnaire: A Cross-Cultural Validation Study of the Danish Version.

PURPOSE: To evaluate the psychometric properties of the Danish Keratoconus Outcome Research Questionnaire (KORQ). METHODS: Phase 1: Rasch analysis assessed the original Danish KORQ. Phase 2: Reengineering of the Danish KORQ to optimize the psychometric properties and functioning of the KORQ. RESULTS: The KORQ was self-administered by 195 patients. Phase 1 displayed trouble with local dependency and poor item fit. In phase 2, local dependency was addressed, and acceptable item fit was obtained for both subscales by collapsing item pairs into superitems (A6+A7, A9+A17, and S6+S9) and deleting 2 items (S4 and S2). After these corrections, the inter-item range was 0.28 to 0.72 for activity limitation scale (AL-S) and 0.14 to 0.54 for symptoms scale (S-S). Ordered thresholds were present, except in items A11, S5, and S10. No differential item functioning was present. Person separation reliability was 0.93 for AL-S and 0.81 for S-S. The person-item maps showed that the target was slightly above the study population. The maximal corneal curvature was the clinical measure of keratoconus with the highest correlation of 0.33 for AL-S and 0.24 for S-S. Evaluating individual questions showed that patients had the most trouble seeing at distance, driving at night, and wearing rigid gas-permeable lenses, whereas the least troublesome areas were walking up/downstairs, doing household tasks, avoiding objects on their path, and doing their job. CONCLUSIONS: The revised Danish KORQ largely fulfilled the assumptions of the Rasch model and displayed satisfactory psychometric properties. The need to revise the Danish KORQ highlights that cross-cultural validation is of key importance when working with patient-reported outcomes.

Astigmatism prediction in small-incision lenticule extraction.

PURPOSE: To investigate whether postoperative-induced refractive astigmatism after small-incision lenticule extraction (SMILE) could be predicted by preoperative objective astigmatism measured with autorefraction, keratometry, and Scheimpflug tomography. SETTING: University eye clinic. DESIGN: Retrospective case series. METHODS: Only eyes without preoperative subjective astigmatism treated with SMILE for myopia were included. Postoperative subjective astigmatism was compared with preoperative objective astigmatism. Examinations were performed before SMILE and 3 months postoperatively and included subjective refraction, keratometry, autorefraction, and Scheimpflug tomographer measurements. Astigmatism was analyzed using double-angle plots and multivariate statistics. RESULTS: A total of 358 eyes of 358 patients were included. The mean preoperative sphere was -7.33 diopter (D) ± 1.46 (SD). The postoperative spherical equivalent was -0.30 ± 0.49 D. Postoperatively, 79.6% and 98.9% of patients had a subjective cylinder ≤0.50 D and ≤1.00 D, respectively. Preoperative objective astigmatism measured with keratometry, autorefraction, and Scheimpflug tomography was significantly different (P < .05) from postoperative subjective refraction when all patients were analyzed; for patients with postoperative refractive astigmatism ≥0.50 D, preoperative astigmatism with keratometry and Scheimpflug tomography was not significantly different from postoperative refractive astigmatism. Preoperative objective astigmatism ≥0.50 D increased the risk ratio of postoperative subjective astigmatism ≥0.50 D by 2.2 (P < .001). CONCLUSIONS: Preoperative objective astigmatism could not be directly interchanged with postoperative subjective astigmatism, but the presence of preoperative astigmatism ≥0.50 D doubled the risk of inducing a postoperative subjective astigmatism ≥0.50 D. Extra care when performing subjective refraction should be taken in the presence of high objective astigmatism.