Preoperative Treatment of Meibomian Gland Dysfunction with a Vectored Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation.

INTRODUCTION: Patients implanted with a range-of-vision intraocular lens (IOL) (multifocal or extended depth of focus, EDOF) may be more susceptible to visual disturbances from poor tear film quality, and prophylactic treatment of meibomian gland dysfunction (MGD) has been recommended. The purpose was to evaluate whether vectored thermal pulsation (LipiFlow™) treatment prior to cataract surgery with a range-of-vision IOL safely improves postoperative outcomes. METHODS: This is a prospective, randomized, open-label, crossover, multicenter study of patients with mild-to-moderate MGD and cataract. The test group underwent LipiFlow treatment prior to cataract surgery and implantation of an EDOF IOL, while the control group did not. Both groups were evaluated 3 months postoperatively, after which the control group received LipiFlow treatment (crossover). The control group was re-evaluated 4 months postoperatively. RESULTS: A total of 121 subjects were randomized, with 117 eyes in the test group and 115 eyes in the control group. At 3 months after surgery, the test group had a significantly greater improvement from baseline in total meibomian gland score compared with the control group (P = 0.046). At 1 month after surgery, the test group had a significant decrease in corneal (P = 0.04) and conjunctival (P = 0.002) staining compared to the control group. At 3 months after surgery, the test group had significantly lower incidence of being bothered by halos compared with the control group (P = 0.019). The control group had a significantly lower incidence of being bothered by multiple or double vision compared with the test group (P = 0.016). After crossover, patients had significant improvement in vision (P = 0.03) and total meibomian gland score (P < 0.0001). No safety concerns or relevant safety findings were uncovered. CONCLUSION: Presurgical LipiFlow treatment of patients implanted with range-of-vision IOLs improved meibomian gland function and postoperative ocular surface health. This supports guidelines recommending proactive diagnosis and management of MGD in patients with cataracts to improve patient experience. TRIAL REGISTRATION: The study was registered on www. CLINICALTRIALS: gov (NCT03708367).

Safety of besifloxacin ophthalmic suspension 0.6% in cataract and LASIK surgery patients.

PURPOSE: The aim of the study was to evaluate the safety of besifloxacin ophthalmic suspension 0.6% as antibacterial prophylaxis in the surgical setting. METHODS: Two prospective safety surveillance studies were conducted-one in the cataract surgery setting and the other in the laser-assisted in situ keratomileusis (LASIK) surgery setting. Cases from patients aged 18 years and above were eligible for inclusion. In both surveillance studies, data were collected from consecutive cases of routine primary cataract surgery and LASIK surgery, respectively, in which besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% was used as the topical perioperative prophylactic antibacterial medication as part of the clinician's routine standard of care. The primary safety endpoint was the incidence of treatment-emergent adverse events (TEAEs). RESULTS: The cataract surgery surveillance study included 485 cases/eyes (besifloxacin, n = 333; moxifloxacin, n = 152), whereas the LASIK surveillance study included 456 cases/eyes (besifloxacin, n = 344; moxifloxacin, n = 112). In the cataract study, only 1 TEAE was reported in a besifloxacin case (mild hypersensitivity/allergic reaction considered possibly related to besifloxacin). No TEAEs were reported in the LASIK study. In both studies, surgical outcomes were similar with both treatments. The frequency of preoperative and/or postoperative dosing was generally lower for besifloxacin than that for moxifloxacin. CONCLUSIONS: In prospective safety surveillance studies of patients undergoing cataract extraction or LASIK, TEAEs associated with prophylactic use of besifloxacin ophthalmic suspension 0.6% were rare, and surgical outcomes with besifloxacin were similar to those with moxifloxacin ophthalmic solution 0.5%.

Changes in posterior corneal elevation after laser in situ keratomileusis enhancement.

PURPOSE: To evaluate changes in posterior corneal elevation using the Pentacam topographer (Oculus) in patients having laser in situ keratomileusis (LASIK) enhancement. SETTING: Private practice, Chevy Chase, Maryland, USA. METHODS: The Pentacam device was used to evaluate the changes in posterior corneal elevation above the best-fit sphere before LASIK enhancement and after LASIK enhancement in 24 eyes. The change in posterior corneal elevation in eyes for which pre-primary LASIK data were available was also evaluated. RESULTS: After LASIK enhancement, the mean change in posterior corneal elevation was 5 microm. The mean posterior corneal elevation was 12 +/- 7 microm before LASIK enhancement and 16 +/- 6 microm after enhancement; the difference was statistically significant (P = .004). In eyes for which pre-primary LASIK data were available, the mean change in posterior corneal elevation after primary LASIK was 2 microm. The mean posterior corneal elevation was 11 +/- 5 microm before LASIK enhancement and 11 +/- 7 microm after enhancement. CONCLUSIONS: There was a statistically significant difference in posterior corneal elevation between before LASIK enhancement and after LASIK enhancement. However, the change in posterior corneal elevation was much smaller than previously reported values and below the sensitivity of the Pentacam topographer.

A novel mutation of the Keratin 12 gene responsible for a severe phenotype of Meesmann's corneal dystrophy.

PURPOSE: To determine if a mutation within the coding region of the keratin 12 gene (KRT12) is responsible for a severe form of Meesmann's corneal dystrophy. METHODS: A family with clinically identified Meesmann's corneal dystrophy was recruited and studied. Electron microscopy was performed on scrapings of corneal epithelial cells from the proband. Mutations in the KRT12 gene were sought using direct genomic sequencing of leukocyte DNA from two affected and two unaffected family members. Subsequently, the observed mutation was screened in all available family members using polymerase chain reaction and direct sequencing. RESULTS: A heterozygous missense mutation (Arg430Pro) was found in exon 6 of KRT12 in all 14 affected individuals studied. Unaffected family members and 100 normal controls were negative for this mutation. CONCLUSIONS: We have identified a novel mutation in the KRT12 gene that is associated with a symptomatic phenotype of Meesmann's corneal dystrophy. This mutation results in a substitution of proline for arginine in the helix termination motif that may disrupt the normal helix, leading to a dramatic structural change of the keratin 12 protein.

Infectious and noninfectious keratitis after laser in situ keratomileusis Occurrence, management, and visual outcomes.

PURPOSE: To retrospectively review the occurrence, treatment, and visual outcomes associated with various etiologies of keratitis as a postoperative complication of laser in situ keratomileusis (LASIK) at an academic surgical center. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. METHODS: The charts of 5618 post-LASIK patients (10 477 eyes) were reviewed for the development of keratitis. Occurrence rates, management regimens, and final best spectacle-corrected visual acuity (BSCVA) were reported for infectious and noninfectious keratitis etiologies. RESULTS: Post-LASIK keratitis was diagnosed in 279 eyes. The keratitis was diagnosed as infectious in 33 eyes (12%) and as noninfectious in 246 eyes (88%). Infectious cases included 5 eyes (15%) with herpes simplex keratitis (HSV), 18 (55%) with adenoviral keratitis, and 10 (30%) with nonviral (including bacterial, fungal, and parasitic) keratitis. Of noninfectious cases, 193 (78%) were classified as diffuse lamellar keratitis (DLK), 36 (15%) as staphylococcal marginal hypersensitivity, and 17 (15%) as localized debris-related keratitis. CONCLUSIONS: The occurrence of post-LASIK keratitis was 2.66%, with DLK being the most common diagnosis overall. The occurrence of noninfectious keratitis (2.34%) was 7.5 times greater than the occurrence of infectious keratitis (0.31%). Adenoviral keratitis had the best visual outcomes overall, with all 18 patients achieving 20/20 BSCVA. In contrast, all 5 eyes with HSV keratitis lost 1 or 2 lines of BSCVA. Excluding adenoviral keratitis, infectious etiologies had significantly worse visual outcomes than noninfectious etiologies at the 20/40 and 20/20 levels (P = .0013 and P<.001, respectively).

Results of late flap removal after complicated laser in situ keratomileusis.

PURPOSE: To evaluate the effect of flap removal on complications after laser in situ keratomileusis (LASIK). SETTING: Three university-based referral centers and 1 private practice. METHODS: This retrospective interventional case series comprised 6 eyes of 6 patients at 4 centers. Flap removal occurred 2 to 41 weeks after the LASIK procedure. The corneal flaps were excised by 2 methods: In 2 eyes, the flap was lifted and excised manually. In 4 eyes, the thin flap was removed by excimer ablation using phototherapeutic keratectomy and/or photorefractive keratectomy. Postoperative measurements included uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), manifest refraction, slitlamp evaluation, and computerized videokeratography. All patients had an 8-month or longer convalescence to assess visual recovery. RESULTS: After the initial flap complication, the BSCVA decreased in all 6 eyes (mean loss 3.0 lines +/- 1.5 [SD]). After flap removal, it improved in all eyes (mean gain 2.2 +/- 1.2 lines). All patients reported a reduction in or elimination of visual symptoms. Despite the improvements, a minor loss of BSCVA (mean -0.8 lines [range 0 to 2 lines]) remained in 4 patients. CONCLUSION: In carefully selected patients, flap removal is a viable surgical option to improve visual function.

Removal of INTACS for myopia.

OBJECTIVE: To evaluate the safety and efficacy of the removal of INTACS. DESIGN: Subgroup analysis from a nonrandomized comparative interventional trial. PARTICIPANTS: Four hundred fifty-two patients with best spectacle-corrected visual acuity of 20/20 or better and myopia (1.0-3.5 diopters [D]) were enrolled in the U.S. Food and Drug Administration clinical trials of INTACS. Forty-six eyes among a total of 684 underwent INTACS removal. INTERVENTION: INTACS removal. METHODS: Safety and efficacy of INTACS removal was assessed by comparison of results from preoperative and 3-month postremoval visits. Safety was assessed by maintenance of preoperative best spectacle-corrected acuity and induction of astigmatism (measured by manifest refraction). Efficacy was assessed by comparison of mean spherical equivalent measured by both manifest and cycloplegic refraction, as well as percentage of eyes within +/- 0.5 D and +/- 1.0 D of baseline values. A subset of 27 patients completed a prospective questionnaire assessing the frequency of six visual symptoms (glare, halos, double vision, photophobia, night vision difficulties, and fluctuating vision). MAIN OUTCOMES MEASURES: Best spectacle-corrected visual acuity, manifest refraction, and cycloplegic refraction. RESULTS: Forty-one of 46 patients' eyes that had undergone INTACS removal had reached the 3-month postremoval visit. Of these eyes, 73% (30 of 41) had returned to within +/- 0.5 D and 97% (40 of 41) to within +/- 1.0 D of baseline spherical equivalent as measured by manifest refraction. With respect to astigmatism, 88% (36 of 41) had returned to within +/- 0.5 D and 100% (41 of 41) to within +/- 1.0 D of preoperative value. No patient had a loss of best spectacle-corrected acuity of more than 2 lines, with equal numbers of eyes having a loss or gain of 1 line (nine eyes) and 2 lines (one eye). For most eyes, INTACS removal was associated with a substantial reduction in the six types of visual symptoms; however, in some eyes (up to 15%) symptoms that had not been detected preoperatively were noted after INTACS removal. CONCLUSIONS: INTACS removal was not associated with a loss (> 2 lines) of best spectacle-corrected visual acuity or induction (> 1 D) of astigmatism or myopia. INTACS removal was associated with a reversal to preoperative values in most cases.