3-Year Outcomes of XEN Implant Compared With Trabeculectomy, With or Without Phacoemulsification for Open Angle Glaucoma.

PRCIS: Trabeculectomy (TRAB) surgery reduces the intraocular pressure (IOP) more than the XEN45 implant over 3 years. There is no difference in the number of antiglaucoma medications between the 2 procedures. The decision to perform either TRAB or XEN45 implantation must be evaluated on a case-by-case basis, taking into account the high rate of needling of the XEN45. PURPOSE: The aim of this study was to compare the differences between the efficacy and safety of the XEN45 implant and TRAB, either alone or in combination with phacoemulsification (PHACO), in patients with open angle glaucoma (OAG) at 36 months. METHODS: A retrospective, single-center and comparative study conducted on OAG patients who underwent XEN45 implantation or TRAB from 2016 to 2018. Patients were divided into 4 groups: group 1 (XEN45 alone), group 2 (XEN45+PHACO), group 3 (TRAB alone), and group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN45 implant), whereas groups 3 and 4 were also combined (TRAB surgery). IOP, number of glaucoma medications, and adverse events were evaluated. The main outcome measure was the reduction in IOP at 36 months postoperatively. RESULTS: One hundred thirty-four patients (134 eyes; 63 XEN45 and 71 TRAB) were included. The mean (95% confidence interval) IOP reduction at the end of the study follow-up was -6.3 (-11.0 to -1.6 mm Hg, P =0.025, XEN45 alone), -8.9 (-11.0 to -6.8 mm Hg, P <0.001, TRAB alone), -2.5 (-4.5 to -0.4 mm Hg, P =0.019, XEN45+PHACO), and -5.6 (-7.7 to -3.4 mm Hg, P <0.001, TRAB±PHACO). The proportion of patients achieving an IOP≥6 and ≤16 mm Hg without treatment at the end of the 36-month follow-up were 50.8% (32/63) in the XEN45 implant and 49.3% (35/71) in the TRAB surgery group, P =0.863. The mean number of glaucoma medications was significantly reduced in all the study groups. The needling rate was 19% in XEN45 versus 5.6% in the TRAB group ( P =0.030), and 2.81% and 36.6% of eyes in the TRAB group presented anterior chamber flattening and hyphema, respectively. CONCLUSIONS: TRAB surgery lowered IOP significantly more than XEN45 implant with or without phacoemulsification over 3 years and had a significantly lower need for additional needling surgery. Both procedures reduced glaucoma medications to a similar rate. These findings are relevant to the informed consent process and patient decisions for one procedure over the other.

XEN implant device versus trabeculectomy, either alone or in combination with phacoemulsification, in open-angle glaucoma patients.

PURPOSE: To compare the efficacy and safety of the XEN45 implant with that of trabeculectomy (TRAB), either alone or in combination with phacoemulsification (PHACO), in patients with open-angle glaucoma (OAG). METHODS: Retrospective, single-center and comparative study conducted on OAG patients. Patients were divided into four groups: group 1 (XEN alone); group 2 (XEN+PHACO); group 3 (TRAB alone); group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN implant), while groups 3 and 4 were also combined (TRAB surgery). The main outcome measure was intraocular pressure (IOP). RESULTS: Ninety-one patients (121 eyes; 65 XEN and 56 TRAB) were included. IOP reduction was - 6.7 (- 10.4 to - 3.0) mmHg, p = 0.0013; - 3.5 (- 5.0 to - 2.0) mmHg, p < 0.0001; - 8.1 (- 10.4 to - 5.9) mmHg, p < 0.0001l; and - 7.3 (- 9.3 to - 5.3) mmHg, p < 0.0001 in the XEN alone, XEN+PHACO, TRAB alone, and TRAB+PHACO, respectively. At month 12, an IOP ≥ 6 and ≤ 16 mm without treatment was achieved by 44 (67.7%) and 43 (76.8%), p = 0.2687 in the XEN implant and the TRAB surgery groups, respectively. The mean number of antiglaucoma medications was significantly reduced in all the study groups (p < 0.0001 each). Needling occurred in 20.0% (13/65) of eyes in the XEN implant group, while hyphema occurred in 30.4% (17/56) of eyes in the TRAB group. CONCLUSIONS: XEN implant, either alone or in combination with phacoemulsification, significantly reduces both IOP and the number of antiglaucoma medications to a similar rate than trabeculectomy, but with a better safety profile.

Identification of novel CYP4V2 genotypes associated with Bietti crystalline dystrophy and atypical anterior segment phenotypes in Spanish patients.

PURPOSE: To identify the spectrum of disease-causing CYP4V2 variants in Spanish patients with clinically diagnosed Bietti crystalline dystrophy (BCD) over an 8-year period and to analyse the phenotype-genotype correlation of the identified variants. METHODS: Four unrelated Spanish probands with a clinical diagnosis of BCD were recruited. Ophthalmological examination included visual acuity (VA), slit lamp examination, in vivo corneal confocal microscopy, funduscopy and fluoresceinic angiography. Genomic DNA was obtained from blood samples, and the exons and flanking intron sequences of the CYP4V2 gene were screened by Sanger sequencing. Family members of the patients with mutations in CYP4V2 gene were subsequently studied. RESULTS: Clinical examination revealed retinal and corneal patterns compatible with BCD in all the participants. We identified a total of six CYP4V2 variants among the four carriers. As far as we know, the variant p.(Trp244Cysfs*33) has not previously been reported. This variant along with p.(Ala204Thr) and p.(Arg443Trp) were combined in three novel pathogenic phenotypes that share the presence of bilateral limbic glistening deposits, severe retinal damage and visual impairment and a fast rate of progression of the disease. CONCLUSION: To the best of our knowledge, this study represents the largest effort to determine the genetic alterations underlying BCD in Spain to date. Our results show that analysis of CYP4V2 variants is required for a reliable diagnosis of BCD. We report a high prevalence of anterior segment changes in this Spanish BCD cohort, which we consider representative of the Spanish patients.

Ten-year follow-up of laser in situ keratomileusis for high myopia.

PURPOSE: To evaluate the long-term outcomes of laser in situ keratomileusis (LASIK) for high myopia. DESIGN: A long-term (10 years) follow-up retrospective interventional case series study. METHODS: The study included 196 myopic eyes of 118 patients with a mean preoperative spherical equivalent of -13.95 +/- 2.79 diopter (D) treated with myopic LASIK at the Instituto Oftalmológico de Alicante, Spain using the VISX 20/20 excimer laser (VISX Inc, Santa Monica, California, USA) and the Automated Corneal Shaper microkeratome (Chiron Vision, Irvine, California, USA). All patients were evaluated three months, one year, two years, five years, and 10 years postoperatively. The main outcome measures were refractive predictability and stability, mean corneal keratometry, topographical cylinder, safety, efficacy, stability of visual acuity, and postoperative complications. RESULTS: At 10 years, 82 (42%) of 196 eyes were within +/-1.00 D and 119 (61%) were within +/-2.00 D. Fifty-four (27.5%) eyes underwent retreatments attributable to under correction and/or regression. The myopic regression decreases with time in eyes that did not undergo retreatment with a mean rate of -0.25 +/- 0.18 D per year. Eleven eyes (5%) lost more than 2 lines of best spectacle-corrected visual acuity (BSCVA) and 78 eyes (40%) showed a postoperatively uncorrected visual acuity of 20/40 or better. Two eyes (1%) with more than 15 D myopic correction developed corneal ectasia. CONCLUSIONS: LASIK for myopia over -10 D is a safe procedure with myopic regression that slows down with time and a high rate of BSCVA increase in the long-term.

Ten-year follow-up of photorefractive keratectomy for myopia of more than -6 diopters.

PURPOSE: To evaluate the long-term outcomes of excimer laser myopic photorefractive keratectomy (PRK) for myopia higher than -6 diopters (D). DESIGN: A long-term (10-year) follow-up retrospective, interventional case series. METHODS: The study included 267 eyes of 191 patients with myopia with spherical equivalent (SE) of more than -6 D treated with myopic PRK at the Instituto Oftalmológico de Alicante, Alicante, Spain, using the VISX 20/20 excimer laser (Santa Clara, California, USA). All patients were evaluated three months, one year, two years, five years, and 10 years after surgery. The main outcome measures were refractive predictability and stability, mean corneal keratometry, topographical cylinder, safety, efficacy, stability of visual acuity, and postoperative complications. RESULTS: At 10 years, 156 (58%) of 267 eyes were within +/- 1.00 D and 209 (78%) were within +/- 2.00 D. One hundred and twenty-four eyes (46.4%) underwent retreatments because of overcorrection, regression, or both. The mean SE decreased (myopic regression) in eyes that did not undergo retreatment, with a mean magnitude of -1.33 +/- 2.0 D over 10 years (-1.13 +/- 0.20 D per year). One hundred and twenty-one (48.3%) of 267 eyes demonstrated increase in best spectacle-corrected visual acuity, and only eight eyes lost lines of vision because of cataract and posterior segment-related complications. The mean corneal haze score decreased gradually from 0.48 +/- 0.69 at three months to 0.09 +/- 0.33 at 10 years. CONCLUSIONS: PRK for myopia of more than -6 D is a safe and effective procedure in the long-term.

Ten-year follow-up of laser in situ keratomileusis for myopia of up to -10 diopters.

PURPOSE: To evaluate the long-term outcomes of laser in situ keratomileusis (LASIK) for myopia of up to -10 diopters (D). DESIGN: A long-term (10-year) follow-up retrospective, interventional case series. METHODS: The study included 97 eyes of 70 patients with a preoperative spherical equivalent (SE) of up to -10 D treated with myopic LASIK at the Instituto Oftalmológico de Alicante, Alicante, Spain, using the VISX 20/20 excimer laser (Santa Clara, California, USA) and the Automated Corneal Shaper microkeratome (Chiron Vision, Irvine, California, USA). All patients were evaluated three months, one year, two years, five years, and 10 years after surgery. The main outcome measures were refractive predictability and stability, mean corneal keratometry, topographical cylinder, safety, efficacy, stability of visual acuity, and postoperative complications. RESULTS: At 10 years, 71 (73%) of 97 eyes were within +/- 1.00 D and 89 (92%) were within +/- 2.00 D. Twenty eyes (20.8%) underwent retreatments because of overcorrection, undercorrection, regression, or both. The mean SE slightly decreased (myopic regression) over 10 years, with a mean myopic regression of -0.12 +/- 0.16 D per year. Fifty-four (54.6%) of 97 eyes demonstrated an increase in best spectacle-corrected visual acuity (BSCVA) after 10 years. No eye developed corneal ectasia in the long-term, and only three eyes lost more than two lines of BSCVA because of complications that were not attributable to the LASIK procedure. CONCLUSIONS: LASIK for myopia of up to -10 D is a safe and effective procedure with slight myopic regression that slows down with time and a high rate of BSCVA increase in the long-term.

Femtosecond laser in situ keratomileusis after radial keratotomy.

PURPOSE: To assess the safety, efficacy, and predictability of femtosecond laser in situ keratomileusis (LASIK) in eyes with previous radial keratotomy (RK). SETTING: Hospital Virgen del Consuelo de Valencia, Valencia, and Vissum Instituto Oftalmológico de Alicante, Alicante, Spain. METHODS: This prospective study comprised 11 eyes of 7 patients with residual low myopia after previous RK who had surgery with the IntraLase femtosecond laser (IntraLase Corp.) and the Star 2 excimer laser (Visx, Inc.). Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), defocus equivalent, refraction, flap thickness, flap diameter, and intraoperative complications were evaluated over a minimum 6-month follow-up. RESULTS: Although the RK incisions opened in all eyes when the flap was lifted, LASIK was successfully completed in all cases. Mean flap thickness was 119 microm +/- 13 (SD). There were no cases of slipped flaps, microstriae, or epithelial ingrowth. Defocus equivalent was reduced from a mean of 2.51 +/- 0.62 diopters (D) to 0.52 +/- 0.28 D; 7 eyes (63.6%) were within +/-0.50 D, and 11 eyes (100%) were within +/-1.00 D. All eyes had 20/40 or better UCVA, although 2 eyes (18.1%) lost 1 line of BSCVA. CONCLUSIONS: The femtosecond laser was safely used to create thin LASIK flaps in eyes with previous RK. An increased postoperative inflammatory response may explain the loss of BSCVA in some cases. Efficacy and predictability of the procedure were comparable to those of LASIK after RK with mechanical microkeratomes.

Ulcerative keratitis caused by Serratia marcescens after laser in situ keratomileusis.

We report 2 cases of severe corneal infections caused by Serratia marcescens after laser in situ keratomileusis (LASIK). Twenty-four hours after LASIK, 2 patients developed infectious keratitis, 1 bilaterally. In each eye, the corneal flap was edematous, ulcerated, and detached from the stromal bed. Treatment included removal of the necrotic flap and aggressive antibiotic therapy. Cultures from corneal exudates were positive for S marcescens. After 1 year, both patients had a loss of best corrected visual acuity (BCVA) ranging from 20/40 to 20/22 because of irregular astigmatism. Overrefraction with a hard contact lens resulted in a BCVA of 20/20 in the 3 affected eyes. Slitlamp examination showed trace subepithelial haze without severe corneal scarring. Videokeratography disclosed areas of paracentral inferior steepening resembling keratoconus. Refraction and videokeratography remained stable after 6 months of follow-up. Ulcerative keratitis caused by S marcescens is a potential complication of LASIK. Bilateral involvement may occur if bilateral simultaneous surgery is performed.