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.

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.

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.

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.

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.

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.

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.

Range of refractive independence and mechanism of action of a corneal shape-changing hydrogel inlay: results and theory.

PURPOSE: To demonstrate the independence of visual performance over a range of preoperative refraction and age in presbyopes implanted with a corneal shape-changing inlay (Raindrop Near Vision Inlay). SETTING: Two multispecialty clinics, Monterrey and Tijuana, Mexico. DESIGN: Prospective case series. METHODS: The nondominant eyes of patients were implanted with the hydrogel corneal inlay beneath a femtosecond flap, centered on the pupil. Clinical outcomes included uncorrected near, intermediate, and distance visual acuity (UNVA, UIVA, and UDVA) and patient-assessed task performance in good light and dim light. Statistical analyses assessed the dependencies on preoperative age (45 to 60 years) and preoperative manifest refraction spherical equivalent (MRSE) (-0.5 to +1.5 diopters [D]). Using the inlay effect derived from wavefront measurements, an eye model was created through which letter charts were simulated. RESULTS: The study evaluated eyes of 188 patients. Postoperative UNVA, UIVA, and task performance at these distances in good light was independent of age and preoperative MRSE (P > .05). Postoperative UDVA was weakly dependent on preoperative MRSE, but distance task performance in good light was not (P > .05). In the treated eye, the mean postoperative UNVA was 20/25, UIVA was 20/25, and UDVA was 20/32. The clinical outcomes are explained by consideration of zones within the pupil generating good near, intermediate, and distance image quality. This was confirmed by visual acuity simulations. CONCLUSIONS: The continuous center-near power profile induced by the corneal shape-changing inlay provides good visual acuity and performance from distance through near over a 2.0 D range of preoperative refraction and presbyopic age. FINANCIAL DISCLOSURE: Drs. Steinert, Schwiegerling, Barragán-Garza, and Chayet are consultants to Revision Optics, Inc. Drs. Lang and Holliday and Mr. Roy are employees of Revision Optics, Inc. Drs. Steinert, Schwiegerling, Barragán-Garza, and Chayet have no financial or proprietary interest in any material or method mentioned.

Safety and efficacy of a hydrogel inlay with laser in situ keratomileusis to improve vision in myopic presbyopic patients: one-year results.

PURPOSE: To study the safety and efficacy of implanting a hydrogel corneal inlay (Raindrop Near Vision Inlay) concurrently with performing laser in situ keratomileusis (LASIK) to treat myopic presbyopia and to compare the results with results of the same treatment in emmetropic and hyperopic patients. SETTING: Two private clinics, Tijuana and Monterrey, Mexico. DESIGN: Prospective nonrandomized clinical trial. METHODS: Bilateral myopic LASIK was performed and a corneal inlay was concurrently implanted in the nondominant eye under a flap created using a femtosecond laser. Primary safety outcomes were the retention of corrected distance (CDVA) and near (CNVA) visual acuities. Efficacy was evaluated on the basis of uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities. A patient questionnaire was used to assess the preoperative and postoperative incidence of visual symptoms, the ability to perform common tasks with no correction, and patient satisfaction with vision. RESULTS: Thirty eyes were enrolled. At each postoperative visit, the mean CDVA and CNVA were within one half line of preoperative measurements and no eye lost 2 or more lines of CDVA. The mean binocular UDVA, UIVA, and UNVA were better than 20/25 Snellen at all postoperative visits. By 6 months, 93% of patients had a binocular Snellen acuity of 20/25 or better across all visual ranges. According to patient questionnaires, 1 year after surgery, visual symptoms were at preoperative levels, 98% of all visual tasks could be easily performed without correction, and 90% of patients were satisfied or very satisfied with their overall vision. CONCLUSION: A hydrogel corneal inlay with concurrent LASIK was safe and effective for treating myopic presbyopia. FINANCIAL DISCLOSURE: Drs. Garza and Chayet are consultants to and investigators for Revision Optics, Inc.

Unfolded protein response activation in cataracts.

PURPOSE: To analyze the expression of 78 kDa glucose-regulated protein (GRP78) and activating transcription factor 6 (ATF6), 2 factors in the unfolded protein response (UPR), in age-related and diabetes-associated cataract. SETTING: Universidad Autónoma de Aguascalientes, Aguascalientes, México. DESIGN: Experimental study. METHODS: The qualitative and quantitative expression of GRP78 and ATF6 were measured in surgical samples from 11 senile cataracts, 9 diabetic-associated cataracts, and 3 normal lenses. Both proteins were detected by immunofluorescence and immunogold-conjugated antibodies. Quantitative morphometry was used to analyze the differences in GRP78 and ATF6 between samples. The Mann-Whitney test was used for statistical analysis. RESULTS: Scanning electron microscopy showed the characteristic organization of fibers in normal lenses with regular alignment and interdigitation between them. On the other hand, lenses from eyes with senile or diabetic cataract showed the same pattern of misalignment and disorganization of the fibers. Both proteins were detected through immunofluorescence in senile and diabetic cataracts, but not in normal lenses. Immunogold-conjugated antibodies and transmission electron microscopy showed that GRP78 and ATF6 grains were 30% higher and 35% higher, respectively, in diabetic cataracts than in senile cataracts (P<.05). CONCLUSIONS: These data show for the first time in humans that GRP78 and ATF6 are present in lens fibers of senile cataracts and diabetic cataracts, establishing that the UPR may be important in the process of cataractogenesis. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Intraocular polyimide intraocular lens haptic breakage long-term postoperatively.

UNLABELLED: We present 2 cases of 3-piece silicone intraoculanbsp;r lenses (IOLs) with broken polyimide haptics. In the first case, the IOL was implanted in the anterior chamber after posterior capsule rupture. Twelve years later, it was explanted and exchanged because of bullous keratopathy. However, on careful manipulation for explantation, the haptics shattered into multiple pieces. In the second case, initial in-the-bag implantation of the IOL was uneventful. Fifteen years later, the IOL dislocated into the anterior chamber as a result of spontaneous in situ haptic breakage. The haptics of both IOLs appeared very brittle during careful manipulation for gross and light microscopy, with further breakage. Scanning electron microscopy of both IOLs revealed no evidence of haptic degradation. Their surfaces appeared smooth and regular with jagged edges where the breaks occurred. Few studies have examined the long-term biocompatibility of polyimide, and more research is needed to determine the cause of this phenomenon. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Combined hydrogel inlay and laser in situ keratomileusis to compensate for presbyopia in hyperopic patients: one-year safety and efficacy.

PURPOSE: To perform a feasibility study of the safety and efficacy of a corneal-contouring inlay with concurrent laser in situ keratomileusis (LASIK) to treat hyperopic presbyopia. SETTING: Private clinic, Tijuana, Mexico. DESIGN: Prospective interventional case series. METHODS: Hyperopic patients received LASIK in both eyes and a corneal inlay under the femtosecond laser flap in the nondominant eye. The inlay is designed to reshape the anterior corneal curvature, creating a near-center multifocal refractive effect. Main safety outcomes were retention of preoperative corrected distance and near visual acuities and reports of adverse events. Efficacy was determined through measurements of near, intermediate, and distance visual acuities and patient questionnaires on visual task ability and satisfaction. RESULTS: The study enrolled 16 patients. All eyes with an inlay achieved an uncorrected near visual acuity (UNVA) of 20/32 or better by the 1-week postoperative examination and at every visit thereafter. The mean monocular and binocular UNVA was 20/27 or better at all visits. The mean binocular uncorrected distance visual acuity improved significantly from 20/53 preoperatively to 20/19 postoperatively (P<10(-5)). One inlay was explanted during the study. At 1 year, all 14 patients analyzed were satisfied or very satisfied with their near, distance, and overall vision. CONCLUSIONS: The hydrogel corneal inlay with concurrent LASIK improved uncorrected near, intermediate, and distance visual acuity in hyperopic presbyopic patients with high patient satisfaction and visual task ability. This represents a new indication for this recently developed technology.

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.

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.

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.

Corneal endothelial safety after ultraviolet light treatment of the light-adjustable intraocular lens.

PURPOSE: To assess the safety to the corneal endothelium of ultraviolet (UV) light treatment to a light-adjustable intraocular lens (IOL). SETTING: Codet Vision Institute, Tijuana, Mexico. DESIGN: Cohort study. METHODS: The study evaluated consecutive patients scheduled for phacoemulsification cataract surgery with implantation of a light-adjustable IOL. Endothelial cell density (ECD), variation in the size of endothelial cells, and the percentage of hexagonal cells were determined centrally with a specular microscope preoperatively, 1 week postoperatively (before UV treatment), and 6 months postoperatively. Two adjustments and 2 lock-in procedures were performed with a light-delivery system between 2 weeks and 4 weeks postoperatively. RESULTS: The study enrolled 10 patients. Specular microscopy showed a mean ECD of 2344 cells/mm(2) preoperatively. The mean overall central ECD was 2047 cells/mm(2) 1 week postoperatively and 2130 cells/mm(2) at 6 months, representing an endothelial cell loss of 12.6% and 9.1%, respectively, from preoperative values. There was no statistically significant difference in the coefficient of variation or percentage of hexagonal cells at either postoperative evaluation. CONCLUSIONS: The endothelial cell loss at 6 months correlated well with previous reports of endothelial damage after phacoemulsification with IOL implantation. The light-adjustable IOL irradiation protocol for adjustment and lock-in procedures did not seem to add to the endothelial damage caused by the cataract surgery, indicating the protocol is safe to the corneal endothelium.