One-year safety and efficacy results of a hydrogel inlay to improve near vision in patients with emmetropic presbyopia.

PURPOSE: To conduct a feasibility study of the safety and efficacy of a corneal contouring inlay as a treatment for emmetropic presbyopia. METHODS: The Raindrop corneal inlay (ReVision Optics, Inc., Lake Forest, CA) was implanted on the corneal stromal bed beneath a keratotomy flap in 20 nondominant eyes of 20 patients. The implant is designed to cause a change in the curvature of the overlying cornea, with a subsequent multifocal change in refractive power. Efficacy outcome was defined as at least 75% of eyes with uncorrected near visual acuity of 0.3 logMAR (20/40 Snellen) or better at 6 months. Main safety outcomes were retention of preoperative best-corrected distance visual acuity and reports of adverse events. Other outcome measures included contrast sensitivity; near, intermediate, and distance visual acuities; patient satisfaction; spectacle use; and complications. RESULTS: All implanted eyes achieved uncorrected near visual acuity of 0.3 logMAR (20/40 Snellen) or better by the 1-week postoperative examination and remained so throughout the 1-year follow-up period, also averaging less than 0.1 logMAR (20/25 Snellen) monocularly and binocularly throughout that period. Mean binocular uncorrected distance visual acuity remained within 0.02 logMAR of the preoperative mean throughout the study. One patient who was dissatisfied with the resulting vision underwent explantation. At 1 year, 16 of 19 patients seldom or never wore glasses and all 19 were satisfied or very satisfied with their overall vision. CONCLUSIONS: The hydrogel corneal inlay improved uncorrected near and intermediate visual acuity in patients with emmetropic presbyopia, with high patient satisfaction and little effect on distance visual acuity.

Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet®.

Aim: To compare pupil dilation achieved by a single microdose versus two microdoses of tropicamide-phenylephrine fixed combination (TR-PH FC) delivered by the Optejet®. Patients & methods: In this assessor-masked, crossover, noninferiority study, 60 volunteers underwent two treatment visits and received either one (∼8 µl) or two sprays (∼16 µl) of TR-PH FC to both eyes in randomly assigned order. Results: At 35 min postdose, mean change in pupil diameter was 4.6 mm and 4.9 mm following one or two sprays, respectively. The estimated treatment group difference was -0.249 mm (standard error: 0.036; 95% CI: -0.320, -0.177). No adverse events were reported. Conclusion: A single microdose was noninferior to two microdoses of TR-PH FC and achieved clinically significant mydriasis in a timely manner. Clinical Trial Registration: NCT04907474 (ClinicalTrials.gov).

Pupil dilation efficacy and efficiency were evaluated using microdosing via the Optejet^®. The Optejet^® is a new ophthalmologic drug device that utilizes piezoelectric technology to deliver a fine, controlled, horizontal microdroplet spray with precise volume (∼8 µl), spray pattern and velocity. A single spray versus two sprays of tropicamide-phenylephrine fixed combination (TR-PH FC) were administered to both eyes anesthetic free. Efficacy and safety were evaluated at specific time intervals. The primary end point was the mean change in pupil diameter at 35 min compared with baseline. At 35 min, clinically relevant dilation was observed, with a mean change of 4.55 mm ± 0.68 for one spray and 4.88 ± 0.60 for two sprays. The treatment group difference of one spray of TR-PH FC was noninferior to two sprays (p < 0.001). Rapid dilation was observed at 15 min, and the proportions of eyes that achieved a pupil diameter of ≥6.0 mm were 74% and 83% of patients at 15 min with one spray and two sprays, respectively. The mydriatic agent was well tolerated with the delivery system even in the absence of topical anesthetic, with no ocular or system adverse events reported. Mydriasis is a vital component of routine eye healthcare, and the current standard-of-care mydriatic eye drops potentially have limitations, including contamination, spillage and burning/stinging. Delivery of a mydriatic with the Optejet^® may improve patient care flow in the clinical office setting.

Prospective, randomized, double-blind, contralateral eye comparison of myopic LASIK with optimized aspheric or prolate ablations.

PURPOSE: To compare the postoperative outcomes of aspheric or prolate LASIK for myopia and myopic astigmatism. METHODS: In this double-blind, bilateral, randomized trial, 40 patients (80 eyes) with -0.75 to -7.00 diopters (D) of manifest refraction spherical equivalent (MRSE) underwent optimized aspheric treatment zone ablation (OATz group) in 1 eye and optimized prolate ablation (OPA group) in the fellow eye. Six-month postoperative outcomes were compared for MRSE and visual acuity, contrast sensitivity, patient satisfaction, ocular higher order aberrations (HOAs), and spherical aberration. The Wilcoxon signed rank test, Mann-Whitney U test, and paired t test were used for testing differences between groups. P<.05 was statistically significant. Main outcome measures included HOAs, spherical aberration, visual and refractive outcomes, and contrast sensitivity. RESULTS: Postoperatively, 36 patients (72 eyes) were evaluated. The MRSE was -0.07±0.23 D for the OPA group and +0.02±0.24 D for the OATz group (P>.05). Two (5%) eyes in the OPA group and 1 (3%) eye in the OATz group (P=.114) lost 1 line of corrected distance visual acuity. Postoperative visual acuity was not statistically different between groups (P>.05). Statistically lower change was noted in spherical aberration (0.011 µm) in the OPA group versus the OATz group (0.099 µm) (P<.001). Statistically higher induction of coma was noted in the OPA group (P=.035). No statistically significant differences were noted in photopic, mesopic, or glare contrast sensitivity and patient satisfaction between groups (P>.05, for all comparisons). CONCLUSIONS: The refractive and visual outcomes of OPA and OATz were equivalent. However, the postoperative optical quality of OPA-treated eyes was better.

Twelve-month clinical outcomes after implantation of a new, modular, anterior shape-changing fluid optic intraocular lens.

PURPOSE: To report the initial safety and effectiveness profile for an anterior shape-changing, modular IOL, Juvene IOL (JIOL), for the treatment of aphakia and presbyopia after removal of the natural crystalline lens due to cataract. SETTING: 2 private practices in Monterrey and Tijuana, Mexico. DESIGN: Exploratory prospective multicenter open-label noncomparative clinical trial. METHODS: A convenience sample of patients aged 50 to 80 years with planned cataract surgery was recruited to undergo unilateral or bilateral implantation with the JIOL. Patients were required to complete an informed consent and be able to dilate to at least 6.0 mm pharmacologically, be in good overall health, and have no significant eye health history to qualify. Visual acuities, defocus curves, and contrast sensitivity were measured for all patients 12 months postoperatively. RESULTS: 51 of 58 eyes completed the 12-month visit. Intraoperative complication rates were extremely low (n = 1; missed base lens tab). The most frequent adverse events (AEs) were prolonged inflammation (N = 6) and cystoid macular edema (N = 4); all AEs were resolved without sequelae by the 12-month visit. The mean monocular logMAR corrected distance visual acuity, distance-corrected intermediate visual acuity, and distance-corrected near visual acuity were 0.01, 0.08, and 0.24, respectively. Defocus testing showed visual acuity > 20/40 from approximately +1.00 through -2.00 diopters. Binocular implantation (n = 16) provided superior performance over monocular implantation. CONCLUSIONS: The JIOL offers a new solution to treat presbyopia, providing clear functional vision performance across a range of distances with an acceptable initial safety profile.

Correction of astigmatism after cataract surgery using the light adjustable lens: a 1-year follow-up pilot study.

PURPOSE: The management of preoperative and residual astigmatism is critical to obtain optimized uncorrected visual acuity. The aim of this study was to determine whether residual astigmatism could be precisely corrected postoperatively using the Light Adjustable Lens (LAL, Calhoun Vision Inc) and to determine the stability of the adjusted refraction. METHODS: Ten eyes of 10 patients with cataract and corneal astigmatism between 1.00 and 2.00 diopters (D) were included. After standard phacoemulsification and implantation of the LAL, adjustment and lock-in procedures were completed. Before adjustment and 2 weeks, 6 months, and 1 year after lock-in, a full ophthalmic examination including uncorrected distance acuity (UDVA) and corrected distance visual acuity (CDVA), autorefraction, and manifest refraction was performed. RESULTS: All surgeries, adjustments, and lock-in procedures were performed with no complications. All eyes achieved ±0.50 D of the targeted cylindrical adjustment. Mean spherical equivalent refraction was 0.03±0.84 D before adjustment and -0.06±0.25 D at final follow-up. The cylinder axis remained the same in 60% of eyes and all eyes were stable within 10° rotation at 12-month follow-up. Seven of 10 eyes achieved UDVA of 20/25 or better whereas all eyes achieved UDVA of 20/32 or better. Corrected distance visual acuity remained stable in all eyes. CONCLUSIONS: In this pilot study, the LAL proved to be an efficient, predictable, and stable method of managing astigmatism in cataract patients.

Gabapentin for postoperative pain after photorefractive keratectomy: a prospective, randomized, double-blind, placebo-controlled trial.

PURPOSE: To determine whether treatment with oral gabapentin reduces postoperative pain after photorefractive keratectomy (PRK). METHODS: This prospective, randomized, double-blind, placebo-controlled study comprised 40 patients scheduled for bilateral PRK. Exclusion criteria were previous refractive surgery; diseases that could affect epithelial healing; use of antihistamines, nonsteroidal anti-inflammatory drugs, or steroids; and use of mitomycin C during PRK. Patients were divided into two groups: 20 patients received gabapentin capsules (300 mg) and 20 patients received identical placebo capsules. Visual acuity, slit-lamp examination, and a 12-question, 10-point visual numerical scale questionnaire were evaluated at each postoperative follow-up. Main outcome measures were the severity of pain at each follow-up and during the previous 24 hours. Secondary outcome measures were maximum and minimum severity of pain, healing time, uncorrected distance visual acuity, and the rating of other symptoms and potential side effects. RESULTS: The gabapentin group had less pain during the first 72 hours (P=.024 to .001). A significant difference in favor of gabapentin was found for the first 48 hours regarding minimum pain severity (P=.005 and .01 for 24 and 48 hours, respectively) and for the first 72 hours for maximum pain severity (P=.014, .007, and .001 for 24, 48, and 72 hours, respectively). No significant differences were observed for side effects, symptoms, or healing time except discomfort in favor of gabapentin during the first 24 hours (P=.043). CONCLUSIONS: Gabapentin significantly reduced postoperative pain after PRK compared to placebo, with no increase in reported side effects.

Eighty-micron flap femtosecond-assisted LASIK for the correction of myopia and myopic astigmatism.

PURPOSE: To evaluate the safety and efficacy of 80-µm flap femtosecond laser-assisted LASIK and the early clinical and refractive outcomes in the correction of myopia and myopic astigmatism. SETTING: Private practice, outpatient. DESIGN: Prospective study. METHODS: Patients who underwent femtosecond-assisted LASIK between February and April 2018 were included. Inclusion criteria were myopia from -1.00 to -8.00 diopters (D) and astigmatism up to -3.00 D and no previous surgeries. All patients were tested preoperatively and on day 1 and month 3 for uncorrected distance visual acuity (UDVA), manifest refraction, corrected distance visual acuity (CDVA), intraocular pressure (IOP), slitlamp and dilated fundus examination, Schirmer I test with anesthesia, and ocular surface disease index questionnaire. The FEMTO LDV Z8 was used for flap construction and the Wavelight Allegretto 400 excimer for refractive treatment. Flap thickness was measured at week 1 with anterior segment optical coherence tomography (AS-OCT). RESULTS: Eighty-two eyes were included. Logarithm of the minimum angle of resolution UDVA was 1.28 ± 0.53 preoperatively, 0.02 ± 0.05 at day 1, and 0.14 ± 0.127 at month 3. There was no loss of CDVA lines. The mean flap thickness measured at 1 week with AS-OCT was 73 ± 6.7 µm. CONCLUSIONS: The use of ultrathin flaps, just below Bowman's layer, with the Ziemer LDV Z8 femtosecond laser was possible, safe, reliable, and reproducible. Eighty-micron flaps allowed for excellent vision on 1 day post-LASIK and might be a good alternative to maintain an appropriate percentage of tissue altered, especially when attempting greater corrections or larger treatment zones.

Correction of myopia after cataract surgery with a light-adjustable lens.

PURPOSE: To determine whether residual myopia could be corrected postoperatively using the light-adjustable lens (LAL) technology in patients undergoing cataract surgery and LAL implantation. DESIGN: A prospective clinical study was conducted at Codet Vision Institute in Tijuana, Mexico. The LALs were implanted that would purposely result in myopic errors of up to -1.5 D (diopter). The LAL was treated with a spatial intensity profile delivered by a digital light delivery device to induce a targeted myopic refractive change. Once the desirable myopic correction was achieved, the LAL was treated again to lock-in the lens power. PARTICIPANTS: Fourteen eyes of 14 patients were studied. METHODS: The manifest refraction, uncorrected visual acuity (UCVA), and best- or spectacle-corrected visual acuity (BCVA), were measured with follow up time of 1 to 9 months to determine the achieved refractive corrections and their stability. MAIN OUTCOME MEASURES: We measured UCVA and BCVA, achieved versus targeted refractive outcome, and refractive stability with follow up time of 1 to 9 months. RESULTS: Of 14 eyes, 13 eyes (92.9%) achieved 0.25 D of the target refraction at 1 day post lock-in with 100% of the eyes achieving the targeted refractive adjustment within 0.5 D or better with up to 9 months postoperative follow-up. All eyes treated show no change in manifest spherical refraction >0.25 D between 1 day post lock-in, and 3, 6, and 9 months postoperative visits. The data demonstrate the stability of the achieved refractive change after the adjustment and lock-in procedures. The mean rate of change was 0.006 D per month, which is 6 times more stable than that of laser corneal refractive procedures. CONCLUSIONS: Residual myopia errors up to -1.5 D were successfully corrected with precision and significant improvement in UCVA and without compromising BCVA using the LAL technology.

Laser in situ keratomileusis for spherical hyperopia and hyperopic astigmatism using the NIDEK EC-5000 excimer laser.

PURPOSE: To assess the efficacy, predictability, and safety of LASIK for the surgical correction of low to moderate hyperopia and hyperopic astigmatism using the NIDEK EC-5000 excimer laser. METHODS: In a multicenter United States Food and Drug Administration (FDA) regulated study of LASIK, 7 centers enrolled 293 eyes with manifest refraction sphere that ranged from +0.50 to +6.00 diopters (D) with or without astigmatism up to 3.00 D. The intended outcome was plano in all eyes. Patients were treated bilaterally. One year postoperative outcomes are reported. RESULTS: The mean spherical equivalent refraction (MRSE) for all eyes changed from +3.51 +/- 1.45 [corrected] D (range: +0.50 to +6.63 D) preoperatively to +0.35 +/- 0.54 D (range: +1.63 [corrected] to +2.00 D) 1 year [corrected] Overall, 61% (170/279) of eyes achieved distance uncorrected visual acuity (UCVA) of 20/20 or better, 82% (228/279) of eyes saw 20/25 or better, and 99% (277/279) of eyes saw 20/40 or better. Refractive accuracy was demonstrated as 63.1% (176/279) of eyes achieved a MRSE within +/- 0.50 D and 90.3% (252/279) of eyes within +/- 1.00 D. Less than 2% (4/279) of eyes lost 2 lines of distance best spectacle-corrected visual acuity. Stability of refraction was demonstrated by 6 months, with a mean hyperopic shift of < 0.03 D from 3 to 6 months. CONCLUSIONS: The NIDEK EC-5000 corrected hyperopia and hyperopic astigmatism with UCVA, refractive accuracy, 1-year stability, and safety that surpassed all FDA criteria.

Topographically guided laser in situ keratomileusis for myopia using a customized aspherical treatment zone.

PURPOSE: To assess the efficacy, predictability, safety, and quality-of-life effects of topography-guided laser in situ keratomileusis (LASIK) for the correction of myopia with astigmatism using the EC-5000 CXII excimer laser equipped with a customized aspheric treatment zone algorithm. SETTING: Ophthalmology clinics in the United States and Mexico. METHODS: In a multicenter United States Food and Drug Administration study of topography-guided LASIK, 4 centers enrolled 135 eyes with a spherical manifest refraction error ranging from -0.50 to -7.00 diopters (D) and astigmatism ranging from 0.50 to 4.00 D. All eyes were targeted for emmetropia. Refractive outcomes, higher-order aberrations (HOAs), and contrast sensitivity were analyzed preoperatively and postoperatively. Patient satisfaction was assessed using 2 questionnaires. RESULTS: Six months postoperatively, the mean manifest refraction spherical equivalent in all eyes was -0.09 D +/- 0.31 (SD); of the 131 eyes, 116 (88.55%) had an uncorrected visual acuity of 20/20 or better and 122 (93.13%) had an MRSE within +/-0.50 D. The best spectacle-corrected visual acuity (BSCVA) increased by 2 or more lines in 21 (16.03%) of 131 eyes; no eye lost 2 lines or more of BSCVA. The total ocular HOA increased by 0.04 microm. Patients reported significantly fewer night driving and glare/halo symptoms postoperatively than preoperatively. CONCLUSION: Use of a customized aspherical treatment zone in eyes with myopia and astigmatism was safe, effective, and predictable and reduced symptoms associated with night driving, glare, and halos.

Early postoperative pain following Epi-LASIK and photorefractive keratectomy: a prospective, comparative, bilateral study.

PURPOSE: To compare postoperative pain associated with epi-LASIK versus photorefractive keratectomy (PRK). METHODS: This prospective observer-masked randomized study included 40 eyes of 20 patients with myopia and astigmatism who received epi-LASIK (Moria Epi-K) in one eye and PRK in the contralateral eye. Corneal ablation was done using the NIDEK EC-5000 excimer laser. Patients were seen at days 1, 3, and 6 to rate their pain via three measuring tools: 1) a global subjective rating, 2) a 10-cm visual analog scale, and 3) an 11-point numeric scale of pain. RESULTS: On postoperative day 1, 19 of 20 patients reported pain in both eyes. Using the global subjective rating scale, patients reported more pain for those eyes treated by PRK. Although clinically relevant, this difference was not statistically significant (P = .56). Based on the 11-point numeric scale of pain and visual analog scale, mean pain scores were similar for both groups. On day 3, using the global subjective rating scale, 11 of 12 patients who had pain reported more in the epi-LASIK treated eye (P = .0005). In addition, epi-LASIK eyes demonstrated higher mean pain scores based on the other two scales (visual analog scale, P = .045 and 11-point numeric scale of pain, P = .023). Only 6 patients reported minimal pain on day 6. It was more frequently reported and slightly more marked in epi-LASIK eyes, but did not reach statistical significance. CONCLUSIONS: Epi-LASIK and PRK have similar pain on postoperative day 1, but epi-LASIK demonstrated statistically more pain than PRK on days 3 and 6.

Corneal remodeling after implantation of a shape-changing inlay concurrent with myopic or hyperopic laser in situ keratomileusis.

PURPOSE: To compare the induced addition (add)-power profile and epithelial remodeling between patients receiving hyperopic and myopic laser in situ keratomileusis (LASIK) concurrently with implantation of a corneal shape-changing inlay. SETTING: Specialty clinics in Monterrey and Tijuana, Mexico. DESIGN: Retrospective case series. METHODS: Preoperative hyperopic patients (mean spherical equivalent [SE] treatment +1.71 diopters [D] ± 0.51 [SD]) and myopic patients (mean SE treatment -2.48 ± 1.33 D) had implantation of a Raindrop Near Vision Inlay in the nondominant eye immediately after the excimer laser ablation in both eyes under a corneal flap. Monocular and binocular visual acuities were recorded at 6 m. Wavefront measurement analysis yielded the mean inlay add-power profile, and optical coherence tomography images yielded the mean epithelial remodeling profile. RESULTS: In the inlay eye in the hyperopic group (n = 34) and myopic group (n = 29), the mean uncorrected near visual acuity exceeded 20/25 (85% 20/25 or better), the mean uncorrected distance visual acuity (UDVA) was 20/32 (62% 20/32 or better), and the mean binocular UDVA was 20/18 (100% 20/25 or better). The add-power profiles for the hyperopic and myopic groups were similar. The epithelial thinning profiles were also the same, thinning centrally by approximately 19 µm, and were uncorrelated with the treated refractive error. CONCLUSIONS: After concurrent LASIK and inlay implantation, the visual acuity, induced add-power profile, and epithelial remodeling were the same, regardless of hyperopic or myopic treatment.

Intraoperative mitomycin and corneal endothelium after photorefractive keratectomy.

PURPOSE: To determine whether there is an increased risk to the corneal endothelium when mitomycin C (MMC) is administered after photorefractive keratectomy (PRK). DESIGN: Prospective, randomized, double-blind, placebo-controlled crossover trial. METHODS: Corneal endothelium was analyzed preoperatively and postoperatively in 18 eyes of nine patients who were administered either MMC- or balanced salt solution (BSS)-supplemented PRK at Codet Aris Vision, Tijuana, Mexico. After laser ablation, one eye was randomly assigned to intraoperative topical MMC 0.02% treatment for 30 seconds, and the fellow eye (the control eye) was treated in a standard fashion with topical BSS. Preoperative pachymetry and endothelial cell count were performed and compared with postoperative measurements after one month and three months. Main outcome measure studied was endothelial cell loss. RESULTS: There was no significant difference in the preoperative endothelial cell count between the 2 groups: MMC group 2835 +/- 395, control group 2779 +/- 492, P = .62. In the control group, at one month and three months the difference in the endothelial cell count was not statistically significant (P = .27, P = .14, respectively). However, in the MMC group the endothelial cell loss was statistically significant: at one month 14.7 +/- 5.1%, and at three months 18.2 +/- 9.0% (P = .0006, P = .002, respectively). CONCLUSIONS: The use of intraoperative topical MMC 0.02% for 30 seconds after PRK may affect the endothelial cell count.

Outcome of simultaneous phakic implantable contact lens removal with cataract extraction and pseudophakic intraocular lens implantation.

PURPOSE: To assess the outcome of simultaneous implantable contact lens (ICL) removal and cataract extraction with pseudophakic intraocular lens (IOL) implantation. SETTING: CODET Aris Vision Institute, Tijuana, Mexico. METHODS: This retrospective noncomparative interventional case series evaluated 14 eyes of 12 patients with ICL implantations who developed a cataract and simultaneously had ICL removal and cataract extraction with IOL implantation. The follow-up time was at least 6 months (range 6 to 24 months). Visual acuity (logMAR), manifest refraction, intraocular pressure, and adverse events were recorded. RESULTS: Of the 12 patients (14 eyes), 10 patients (12 eyes) had ICL surgery to correct high myopia and 2 patients (2 eyes), to correct hyperopia. The mean uncorrected visual acuity after ICL implantation (before cataract development), before cataract surgery, and after cataract surgery were 0.48 +/- 0.32, 0.83 +/- 0.34, and 0.40 +/- 0.27, respectively. The mean best corrected visual acuity (BCVA) before ICL implantation, after ICL implantation, and after cataract surgery were 0.31 +/- 0.21, 0.28 +/- 0.19, and 0.27 +/- 0.21, respectively. The mean final manifest spherical equivalent was 0.30 diopters (D) +/- 1.07 (SD) (range +2.38 to 2.0 D). Ten eyes (71.4%) were within +/-1.0 D of the calculated target. One eye had a tear in the posterior capsule with vitreous loss during cataract surgery. No other intraoperative, perioperative, or postoperative complications were observed. No loss of BCVA was recorded at the last postoperative visit. CONCLUSIONS: Lens opacities and cataract formation are a potential complication of ICL surgery. The removal of the ICL and the cataract with IOL implantation was found to be safe, with predictable refractive results.

In vivo architectural analysis of 3.2 mm clear corneal incisions for phacoemulsification using optical coherence tomography.

PURPOSE: To analyze in vivo the architecture of clear corneal incisions (CCIs) for phacoemulsification using optical coherence tomography (OCT). SETTING: Anterior Segment Department, Asociacion Para Evitar la Ceguera en Mexico, Hospital Dr Luis Sanchez Bulnes, Mexico. METHODS: A prospective masked study analyzed 20 unsutured CCIs placed superiorly and created in a uniplanar fashion with a 3.2 mm slit-angled metal keratome. All wounds were evaluated with a retinal OCT model 1, 3, and 30 days postoperatively. Intraocular pressure (IOP) and incision leakage were checked. The architecture was described according to the angle of incidence, apposition of the epithelial and endothelial margins, and wound sealing. RESULTS: No leakage was detected. The angle varied from 33 to 85 degrees; angles greater than 75 degrees were done by a surgeon in training. Wound apposition at the epithelial margin was achieved in all cases. In contrast, imperfect apposition of the endothelial margin was seen in 45% of incisions on day 1 and in 15% on day 30. Incomplete sealing of the wound was seen by OCT in 25% of cases at 24 hours and persisted in 10% of all cases at 1 month. This gaping occurred on the endothelial side and never translated to the epithelial margin. No statistical correlation was found between gaping and the angle of the incision, IOP variations, or surgeon experience. CONCLUSIONS: Although in vivo CCIs caused minor anatomic imperfections, they were clinically stable independent of incision angle, IOP variation, and surgeon experience. Incision stability may be related to careful wound construction, epithelial viability, stromal edema, and efficient endothelial pumping.

Structural Changes Induced by a Corneal Shape-Changing Inlay, Deduced From Optical Coherence Tomography and Wavefront Measurements.

PURPOSE: Changes to the anterior stroma and epithelium induced by a meniscus-shaped corneal inlay are presented. The hypothesis that local curvature is a driver of epithelial remodeling is tested. METHODS: Records of 30 subjects enrolled in a prospective clinical investigation of the inlay, implanted in emmetropic presbyopic subjects, were analyzed. The change to the anterior corneal surface was measured using wavefront techniques. The epithelial thinning profile was measured using Fourier domain optical coherence tomography. The stromal change was calculated from the two measurements. RESULTS: The inlay's volume displaced the stroma anterior to the inlay, which was reflected in the change of Bowman's layer shape. The epithelium anterior to the inlay thinned by 18.4 ± 7.1 µm. Peripheral to the inlay's diameter (2 mm), circumferential epithelial thickening extended the change to the anterior corneal surface to approximately twice the inlay diameter. The central anterior corneal surface rose by 9.8 ± 3.4 µm, creating a progressive add power profile. The epithelial thinning was linearly related to the curvature of the alteration to the anterior surface height, consistent with a theoretical model. CONCLUSIONS: When a meniscus-shaped corneal inlay is placed beneath a corneal flap, the flap's stroma takes on predominately the inlay's shape. The epithelium remodels within a zone approximately twice the inlay diameter, with an anterior corneal height change providing improved near and intermediate vision. The relationship between the epithelial, stromal, and anterior corneal surface changes confirms the hypothesis that epithelial changes are greatest in regions of greater local surface curvature.

Pharmacodynamic profile of mydriatic agents delivered by ocular piezo-ejection microdosing compared with conventional eyedropper.

AIM: Eyedroppers deliver medication volumes exceeding conjunctival absorptive capacity, causing spillage and risking ocular/systemic complications. We evaluated piezoelectric microdosing. Results/methodology: Subjects (n = 102) received precision microdroplet delivery of phenylephrine (2.5%) and tropicamide (1.0%): 1 × 1.5 µl, 1 × 6 µl or 2 × 3 µl of each (randomized 1:1:1), into one eye. Contralateral eyes received eyedropper doses of both drugs. Outcomes were pupil dilation (0-60 min) and patient satisfaction. Six-microliter microdosing achieved comparable, and 2 × 3 µl met/exceeded dilation speed and magnitude versus eyedropper. Separately, participants preferred piezoelectric saline self-delivery to eyedroppers, reporting better head-positioning comfort, reduced tearing/overflow and increased likelihood of adhering to ocular medication regimens. CONCLUSION: Piezoelectric microdosing achieves comparable effects as eyedroppers delivering 4-17-fold larger doses. Microdosing may enhance patient adherence to ocular medication regimens while minimizing side effects.

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

BACKGROUND: Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. METHODS: This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. RESULTS: Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted. CONCLUSION: Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

Incidence of complications during flap creation in LASIK using the NIDEK MK-2000 microkeratome in 26,600 cases.

PURPOSE: To evaluate the incidence of intraoperative complications using the NIDEK MK-2000 microkeratome during flap creation in LASIK. METHODS: The incidence of intraoperative flap complications during LASIK using the NIDEK MK-2000 microkeratome was retrospectively studied in 26,600 procedures performed in 5 outpatient excimer laser surgery centers. RESULTS: A total of 65 (0.244%) complications were identified: 23 (0.086%) eyes had free caps, 13 (0.049%) eyes had an incomplete pass, 13 (0.049%) eyes had an epithelial defect, 11 (0.041%) eyes had buttonhole, and 5 (0.019%) eyes had irregular flap. The remaining 26,535 (99.756%) eyes had uneventful flap creation. CONCLUSIONS: Use of the NIDEK MK-2000 microkeratome resulted in a low incidence of intraoperative complications, making it a safe and reliable device for creating flaps during LASIK.

Comparison of postoperative pain in patients following photorefractive keratectomy versus advanced surface ablation.

PURPOSE: To compare postoperative pain associated with advanced surface ablation versus traditional photorefractive keratectomy (PRK). SETTING: Codet-Aris Vision Institute, Tijuana, Mexico. METHODS: This prospective double-masked randomized study included 56 eyes of 28 myopic patients who received traditional PRK in 1 eye and advanced surface ablation in the contralateral eye. For advanced surface ablation, removal of corneal epithelium was performed by incubating the cornea with 18% ethanol. Subsequently, the epithelium was removed by a surgical microsponge. For eyes treated by PRK, mechanical debridement of corneal epithelium was performed with a surgical blade. Excimer laser corneal ablation was performed using the Nidek EC-5000 excimer laser in all eyes. On postoperative days 1 and 3, patients were instructed to rate their pain via 3 pain measuring tools: (1) a global subjective rating; (2) a 100 mm visual analog scale (VAS); and (3) an 11-point numerical rating scale. RESULTS: All 28 patients completed postoperative questionnaires on day 1 and day 3. On postoperative day 1, all reported pain in both eyes. Using the global assessment rating, patients reported statistically significant more pain in eyes treated by advanced surface ablation (P = .0037; confidence interval [CI], 59%-92%). Furthermore, based on the 11-point numerical rating scale, mean pain scores were significantly higher in the advanced surface ablation treated eyes (P = .0121), while the VAS mean pain scores were marginally significantly higher (P = .0822). On postoperative day 3, 23 patients reported the presence of some pain, at least in 1 eye. Using the global assessment rating, 70% of the those who had pain reported more pain in the advanced surface ablation-treated eye (advanced surface ablation 16/23 versus PRK 7/23) (P = .0931; 95% CI, 47%-87%). In addition, on postoperative day 3, advanced surface ablation-treated eyes demonstrated slightly higher mean pain scores based on the 11-point numerical rating scale and on the VAS; however, mean differences were not statistically significant (P = .3494 and P = .3337, respectively). CONCLUSIONS: Advanced surface ablation was associated with statistically significantly more postoperative pain than PRK on postoperative day 1. A greater percentage of patients reported more pain in the advanced surface ablation-treated eyes on day 3. Refractive surgeons should consider the postoperative pain associated with advanced surface ablation when deciding on the type of epithelial debridement for their patients.