Janus kinase inhibitor ruxolitinib in combination with nilotinib and prednisone in patients with myelofibrosis (RuNiC study): A phase Ib, multicenter study.

This phase Ib, non-randomized, open-label study evaluates the safety and tolerability of ruxolitinib in combination with nilotinib and prednisone in patients with naïve or ruxolitinib-resistant myelofibrosis (MF). A total of 15 patients with primary or secondary MF received the study treatment; 13 patients had received prior ruxolitinib treatment (86.7%). Eight patients completed seven cycles (53.3%) and six patients completed twelve cycles of treatment (40%). All the patients experienced at least one adverse event (AE) during the study (the most common AEs were hyperglycemia, asthenia, and thrombocytopenia), and 14 patients registered at least one treatment-related AE (the most common treatment-related AEs were hyperglycemia (22.2%; three grade 3 cases). Five treatment-related serious AEs (SAEs) were reported in two patients (13.3%). No deaths were registered throughout the study. No dose-limiting toxicity was observed. Four out of fifteen (27%) patients experienced a 100% spleen size reduction at Cycle 7, and two additional patients achieved a >50% spleen size reduction, representing an overall response rate of 40% at Cycle 7. In conclusion, the tolerability of this combination was acceptable, and hyperglycemia was the most frequent treatment-related AE. Ruxolitinib in combination with nilotinib and prednisone showed relevant clinical activity in patients with MF. This trial was registered with EudraCT Number 2016-005214-21.

Patient Satisfaction and Visual Performance in Patients with Ocular Pathology after Bilateral Implantation of a New Extended Depth of Focus Intraocular Lens.

Aim: To evaluate visual results and patient-perceived outcomes in patients with ocular pathologies implanted with a new extended depth-of-focus intraocular lens (IOL). Methods: Patients with ocular pathology undergoing cataract surgery and bilaterally implanted with Vivity® IOLs were evaluated three months after surgery. The control group included patients with no ocular pathologies. Binocular defocus curves, corrected and uncorrected mono- and binocular distance visual acuity (DVA), and binocular contrast sensitivity were measured. Patients completed the Catquest-9SF questionnaire and reported on dysphotopsia and their need for spectacle-correction. Results: Twenty-five patients were included in each group. Monocular uncorrected DVA was better in the control group (-0.01 ± 0.07) compared with the study group (0.03 ± 0.08), p=0.027. There were no other statistically significant differences in DVA, with an uncorrected binocular acuity of -0.06 ± 0.06 for the control group and -0.05 ± 0.06 for the study group. Binocular defocus curves were similar for both groups and there were no differences in contrast sensitivity values. Pooling the refractive results, 96% of eyes were within ±0.50 D of target refraction. Seventy percent of patients in the control group reported no halos, compared with 40% in the study group, p=0.047. In both groups, 40% of patients reported being completely spectacle-independent, with the other 60% requiring glasses for near vision always or often. All patients reported being fairly or very satisfied with their vision. Conclusion: Initial results of visual function after Vivity implantation in patients with ocular pathologies are encouraging, with high patient satisfaction and few difficulties for daily activities.

Visual and Refractive Outcomes of Cataract Surgeries Performed in One Year in a Private Practice Setting: Review of 2714 Procedures.

METHODS: Our center's database was used to identify all isolated cataract procedures performed during 2017. The electronic records were reviewed to collect the preoperative information, presence of intra- or postsurgical complications, and visual and refractive outcomes one month after surgery. RESULTS: In 2017, 2714 eyes of 1543 patients underwent cataract surgery in our center. Mean patient age was 70.42 years. 775 eyes (28.55%) had prior ophthalmic pathologies, and 113 eyes (4.16%) had undergone previous surgical procedures. Surgical complications developed in 35 eyes (1.29%), including 9 posterior capsule tears (0.33%) and 3 cases of dropped lens fragments (0.11%). A toric or multifocal intraocular lens was implanted in 45.6% of eyes. As regards postoperative complications, 59 eyes (2.17%) required a return to the operating theater, including 29 eyes (1.07%) requiring reinterventions due to an unexpected refractive result. There were no cases of endophthalmitis. Mean LogMAR-corrected distance visual acuity (CDVA) improved from 0.25 (SD 0.34) preoperatively to 0.04 (SD 0.17) postoperatively; 86.5% of eyes achieved a CDVA ≤0.0, with 97.5% achieving ≤0.3. In 86.4% of eyes, the difference between target and residual spherical equivalent difference was of 0.50 D or lower; 88% of eyes had a spherical equivalent ±0.50 D. CONCLUSIONS: The visual and refractive outcomes of cataract surgery in a private practice setting were excellent, well over the benchmarks set by the ESCRS. The safety profile was also within expected standards. This study provides information for ophthalmologists in private practice on expected outcomes.

New prognosis score including absolute lymphocyte/monocyte ratio, red blood cell distribution width and beta-2 microglobulin in patients with diffuse large B-cell lymphoma treated with R-CHOP: Spanish Lymphoma Group Experience (GELTAMO).

The International Prognostic Index (IPI) is the most widely used score for non-Hodgkin lymphoma but lacks the ability to identify a high-risk population in diffuse large B-cell lymphoma (DLBCL). Low absolute lymphocyte count and high monocytes have proved to be unfavourable factors. Red-cell distribution width (RDW) has been associated with inflammation and beta-2 microglobulin (B2M) with tumour load. The retrospective study included 992 patients with DLBCL treated with R-CHOP. In the multivariate analysis, age, Eastern Cooperative Oncology Group performance status (ECOG-PS), stage, bulky mass, B2M, RDW, and lymphocyte/monocyte ratio (LMR) were independently related to progression-free survival (PFS). A new prognosis score was generated with these variables including age categorized into three groups (0, 1, 2 points); ECOG ≥ 3-4 with two; stage III/IV, bulky mass, high B2M, LMR < 2·25 and RDW > 0·96 with one each; for a maximum of 9. This score could improve the discrimination of a very high-risk subgroup with five-year PFS and overall survival (OS) of 19% and 24% versus 45% and 59% of R (revised)-IPI respectively. This score also showed greater predictive ability than IPI. A new score is presented including complete blood cell count variables and B2M, which are readily available in real-life practice without additional tests. Compared to R-IPI, it shows a more precise high-risk assessment and risk discrimination for both PFS and OS.

Influence of preoperative keratometry on refractive results after laser-assisted subepithelial keratectomy to correct myopia.

PURPOSE: To study the relationship between preoperative keratometry and residual spherical equivalent (SE) after myopic laser-assisted subepithelial keratectomy (LASEK). SETTING: Vissum Madrid, Madrid, Spain. METHODS: This retrospective study comprised 1149 consecutive eyes that had LASEK to correct myopia. The relationship between preoperative keratometry and the 3-month postoperative SE was analyzed by linear regression. The same analysis was performed in the first decile (percentile 10) with the flattest keratometry readings, in the decile with the steepest readings, and in the quartiles with the lowest and highest preoperative myopia. RESULTS: Preoperatively, the mean SE was -4.59 diopters (D) +/- 2.80 (SD) (range -0.25 to -13.00 D) and the mean keratometry, 44.20 +/- 1.60 D (range 39.00 to 49.00 D). Three months postoperatively, the mean SE was +0.05 +/- 0.50 D. There was a significant (P = .04), although weak (r2 = 0.003), correlation between the mean preoperative keratometry and residual SE. Linear regression showed a positive significant correlation within each decile. The correlation was weak in the decile with the flattest corneas (115 eyes) (r2 = 0.04, P = .04) and slightly stronger in the decile with the steepest corneas (115 eyes) (r2 = 0.1, P = .001) (ie, the steeper the cornea, the greater the overcorrection). There was a weak correlation in the group with higher preoperative myopia (r2 = 0.05, P = .0003) but no correlation in the lower myopia group (P = .3). CONCLUSION: Preoperative corneal curvature did not seem to influence the spherical refractive outcomes after myopic LASEK.

Comparison between LASEK with mitomycin C and LASIK for the correction of myopia of -7.00 to -13.75 D.

PURPOSE: To compare laser epithelial keratomileusis (LASEK) and LASIK for the correction of high myopia. METHODS: A prospective, single-masked study was conducted. Patients treated with LASEK to correct myopia > or = -7.00 diopters (D) (spherical equivalent manifest refraction) with a cylinder < or = -3.50 D (LASEK group) were compared to patients treated with LASIK (LASIK group) using the same excimer laser (Technolas 217C). Mitomycin C (MMC) 0.02% was applied for 1 minute in all LASEK-treated eyes. RESULTS: A total of 228 consecutive eyes were included in the study (114 in each group, matched for preoperative refraction). The mean preoperative spherical equivalent manifest refraction was -8.72 +/- 1.20 D in the LASEK group and -8.74 +/- 1.20 D in the LASIK group (range: -7.00 to -13.75 D) (P = .9). Uncorrected visual acuity (UCVA) was significantly lower in LASEK eyes 1, 7, and 30 days postoperatively (P = .0001 for each comparison). No significant differences were found at 3 months postoperatively in UCVA (P = .3), best spectacle-corrected visual acuity (BSCVA) (P = .2), or in the safety (P = .6) and efficacy (P = .8) indices. Uncorrected visual acuity was 1.0 or better in 34.2% of LASEK eyes and 44.7% of LASIK eyes. Spherical refraction was +0.25 +/- 0.6 D after LASEK and -0.06 +/- 0.5 D after LASIK (P = .0001). Sixty-eight percent of LASEK eyes and 79% of LASIK eyes were within +/- 0.50 D of intended refraction. No LASEK eye versus 7 LASIK eyes lost 2 lines of BSCVA. Eight LASEK eyes gained 2 or more lines of BSCVA versus 1 LASIK eye. CONCLUSIONS: Visual improvement after LASEK with intraoperative MMC was significantly slower than after LASIK. Visual outcomes (UCVA, BSCVA, and safety and efficacy indices) 3 months after surgery were similar with both techniques for the correction of high myopia. Ten percent more eyes after LASIK were within +/- 0.50 D of intended refraction.

Stability of laser epithelial keratomileusis with and without mitomycin C performed to correct myopia in thin corneas: a 15-month follow-up.

PURPOSE: To study the stability of the refraction 15 months after myopic laser epithelial keratomileusis (LASEK) performed in thin corneas with and without adjuvant mitomycin C (MMC). DESIGN: Retrospective review. METHODS: One hundred and thirty-six consecutive eyes that had undergone LASEK to correct their myopia and that had a preoperative central corneal thickness (CCT) of <500 microm at Vissum Madrid, Spain, were included. Intraoperative MMC was applied when the ablation depth exceeded 50 microm (49 eyes). We compared the residual refraction between the three- and 15-month examinations to detect a possible myopic change that would suggest secondary corneal ectasia. RESULTS: Mean preoperative CCT +/- standard deviation (SD) was 484.4 +/- 11.8 microm (range, 440 to 499 microm). Mean CCT +/- SD three months after surgery was 417.9 +/- 32.1 microm (range, 339 to 473 microm). Mean preoperative spherical refraction +/- SD was -3.49 +/- 2.10 diopters (D). Mean preoperative cylinder +/- SD was -0.87 +/- 1.20 D. The mean residual sphere +/- SD was 0.15 +/- 0.40 D three months after surgery and 0.11 +/- 0.60 D 15 months after surgery (P = .45). The mean cylinder +/- SD was -0.13 +/- 0.30 D and -0.25 +/- 0.50 D, respectively (P = .06). Both the uncorrected visual acuity (UCVA) and the best-spectacle corrected visual acuity (BSCVA) showed statistically significant improvement on the 15-month examination (P = .01 and P = .0001, respectively). When analyzed separately, the subgroup treated with intraoperative MMC also showed stability of the refraction and a statistically significant improvement both in UCVA and in BSCVA. Topography showed no signs of ectasia in any case. CONCLUSIONS: Myopic LASEK performed on thin corneas, regardless of the use of intraoperative MMC, seems to obtain stable refractive results, with no sign of ectasia during a 15-month follow-up.

LASEK versus LASIK for the correction of moderate myopia.

PURPOSE: To compare the results of laser subepithelial keratomileusis (LASEK) and laser in situ keratomileusis (LASIK) for the correction of moderate myopia. METHODS: We performed a retrospective, single-masked, interventional study of 80 consecutive eyes. Forty eyes that had undergone LASEK to correct myopia of -2.0 to -6.0 D were compared with age and refraction matched patients treated with LASIK. All eyes had been operated by the same experienced surgeon using the same laser (Technolas 217). Mitomycin C was not used in any patient. RESULTS: Eighty eyes were reviewed (40 treated with LASEK, 40 treated with LASIK). The preoperative mean sphere was -3.8 D (range -2 to -6D) and mean cylinder was -0.7 D (range 0 to -2 D) in both groups. Postoperative uncorrected visual acuity was worse in LASEK eyes 1 and 7 days postoperatively (p = 0.0001), although the difference 7 days postoperatively ( 0.05). CONCLUSIONS: LASEK and LASIK seem to be similar in terms of safety and efficacy for the correction of moderate myopia. Nevertheless, a trend toward overcorrection was found in the LASEK group in correlation with a higher preoperative refractive error.

Learning curve of laser-assisted subepithelial keratectomy: influence on visual and refractive results.

PURPOSE: To study the effect of the learning curve of laser-assisted subepithelial keratectomy (LASEK) on the visual and refractive results. METHODS: This retrospective study comprised 56 eyes that had LASEK for myopia. The eyes were among the first 143 that had LASEK by the same surgeon with the same excimer laser and same nomogram. The 56 eyes were separated into 2 groups. Group 1 included the first 28 eyes to have LASEK by the surgeon. Group 2 comprised the last 28 eyes in the series whose refractive error could be matched with that in Group 1. The outcomes in the 2 groups were compared. RESULTS: The mean preoperative spherical refraction was -3.90 diopters (D) +/- 1.90 (SD) in Group 1 and -3.70 +/- 2.53 D in Group 2 (P = .2). There were no significant differences in preoperative cylinder or best spectacle-corrected visual acuity (BSCVA) between groups. The postoperative uncorrected visual acuity (UCVA) was significantly worse in Group 1 on 1 day and 7 days postoperatively (P = .02 and P = .03, respectively); there was no significant difference at 1 month and 3 months. The safety index (postoperative BSCVA/preoperative BSCVA) and efficacy index (postoperative UCVA/preoperative BSCVA) were better in Group 2, although the difference was not statistically significant. The spherical refraction 3 months postoperatively was +0.50 +/- 0.83 D in Group 1 and +0.10 +/- 0.27 D in Group 2 (P = .02); 75.00% of eyes and 96.42% of eyes, respectively, were within +/-0.50 D of the intended correction (P = .01). Seven percent of eyes in Group 1 and no eye in Group 2 lost 2 or more lines of BSCVA. CONCLUSIONS: Results indicate that the outcomes of LASEK depend on surgeon experience. Thus, caution is advised when interpreting LASEK results without knowing the surgeon's level of experience.

Comparison between LASEK and LASIK for the correction of low myopia.

PURPOSE: To compare the refractive results of laser epithelial keratomileusis (LASEK) and laser in situ keratomileusis (LASIK) for the correction of low myopia. METHODS: A prospective, interventional, non-randomized, observer-masked study was performed of patients with myopia of < or = -2.50 diopters (D) (cylinder < or = 1.50 D) who had undergone either LASEK or LASIK. Refractive analysis was performed by a masked observer preoperatively and 1 day, 1 week, and 1 and 3 months postoperatively. RESULTS: Seventy-nine eyes that fulfilled the inclusion criteria in each group were included in the study. No statistically significant differences were noted in age, gender, or preoperative refractive error between groups. Postoperative uncorrected visual acuity (UCVA) was significantly lower in LASEK eyes 1 and 7 days postoperatively (P = .0001). At 1 and 3 months postoperatively, no significant differences were noted between the groups in UCVA (P = .07), but best spectacle-corrected visual acuity 3 months postoperatively was significantly better in LASEK eyes (P = .01). The refractive error was similar in both groups (P = .3). CONCLUSIONS: Visual improvement after LASEK for low myopia is significantly slower than after LASIK. Visual outcomes at 3 months postoperatively were similar with both techniques for the correction of low myopia.