Comparison of Legacy and New No-History IOL Power Calculation Formulas in Postmyopic Laser Vision Correction Eyes.

PURPOSE: To compare the refractive accuracy of legacy and new no-history formulas in eyes with previous myopic laser vision correction (M-LVC). DESIGN: Retrospective cohort study. METHODS: Setting: Two academic centers Study Population: 576 eyes (400 patients) with previous M-LVC that underwent cataract surgery between 2019-2023. A SS-OCT biometer was used to obtain biometric measurements, including standard (K), posterior (PK), and total keratometry values (TK). OBSERVATION PROCEDURES: Refractive prediction errors were calculated for 11 no-history formulas: two legacy M-LVC formulas, four new M-LVC formulas using K values only, and five new M-LVC formulas using K with PK or TK. MAIN OUTCOME MEASURES: Heteroscedastic testing was used to evaluate relative formula performance, and formulas were ranked by root mean square error (RMSE). RESULTS: New M-LVC formulas performed better than legacy M-LVC formulas. New M-LVC formulas with PK/TK values performed better than versions without PK/TK values. Among new M-LVC formulas with PK/TK values, EVO 2.0-PK was superior to Hoffer QST-PK (P < 0.005). Among new M-LVC formulas using K only, Pearl DGS-K and EVO 2.0-K were both superior to Hoffer QST-K and Barrett True K NH-K formulas (all P < 0.005). CONCLUSIONS: Surgeons should favor using new no-history post M-LVC formulas over legacy post M-LVC formulas whenever possible. The top-performing M-LVC formulas (EVO 2.0-PK, Pearl DGS-PK, and Barrett True K-TK) utilized posterior corneal power values. Among formulas utilizing K alone, the EVO 2.0-K and Pearl DGS-K performed best.

Leaving trusted paths: Estimating corneal keratometric index in cataract surgery eyes with zero-power implants.

PURPOSE: This study aimed to estimate the corneal keratometric index in the eyes of cataract surgery patients who received zero-power intraocular lenses (IOLs). METHODOLOGY: This retrospective study analyzed postoperative equivalent spherical refraction and axial length, mean anterior curvature radius and aqueous humor refractive index to calculate the theoretical corneal keratometric index value (nk). Data was collected from 2 centers located in France and Germany. RESULTS: Thirty-six eyes were analyzed. The results revealed a mean corneal keratometric index of 1.329 ± 0.005 for traditional axial length (AL) and 1.331 ± 0.005 for Cooke modified axial length (CMAL). Results ranged from minimum values of 1.318/1.320 to maximum values of 1.340/1.340. CONCLUSION: The corneal keratometric index is a crucial parameter for ophthalmic procedures and calculations, particularly for IOL power calculation. Notably, the estimated corneal keratometric index value of 1.329/1.331 in this study is lower than the commonly used 1.3375 index. These findings align with recent research demonstrating that the theoretical corneal keratometric index should be approximately 1.329 using traditional AL and 1.331 using CMAL, based on the ratio between the mean anterior and posterior corneal curvature radii (1.22).

Change in refractive errors with changes in IOL parameters.

This study considered two questions associated with intraocular lens (IOL) power and refraction: (1) Given a refraction with a particular IOL in the eye, what will be the refraction for the IOL or another IOL if located differently with regard to tilt or anterior-posterior position? (2) For a target refraction, what is the power of another IOL if located differently with regard to tilt or position? A thin lens technique was developed to address these questions. For the first question, light was traced through the initial correcting spectacle lens to the cornea, refracted at the cornea, transferred to the position of the initial IOL, refracted at this IOL, transferred to the position of a new IOL (which may be the same IOL but with a different position and/or tilt), refracted backwards through the new IOL, transferred to the cornea and refracted out of the eye to give a new correcting spectacle lens power. For the second question, light was traced through the initial correcting spectacle lens to the cornea, refracted at the cornea, transferred to the position of the initial IOL, refracted at the initial IOL and transferred to the position of a new IOL. Light was also traced through the second correcting spectacle lens, refracted at the cornea and transferred to the position of the second IOL. The difference between the reduced image vergence for the first raytrace and the reduced object vergence for the second raytrace gave the effective power of the second IOL, and from this, the power of the second IOL was determined. Examples are presented for different situations, including a case report.

Modified intraocular lens power selection method according to biometric subgroups Eom IOL power calculator.

This study evaluates the accuracy of a newly developed intraocular lens (IOL) power calculation method that applies four different IOL power calculation formulas according to 768 biometric subgroups based on keratometry, anterior chamber depth, and axial length. This retrospective cross-sectional study was conducted in at Korea University Ansan Hospital. A total of 1600 eyes from 1600 patients who underwent phacoemulsification and a ZCB00 IOL in-the-bag implantation were divided into two datasets: a reference dataset (1200 eyes) and a validation dataset (400 eyes). Using the reference dataset and the results of previous studies, the Eom IOL power calculator was developed using 768 biometric subgroups. The median absolute errors (MedAEs) and IOL Formula Performance Indexes (FPIs) of the Barrett Universal II, Haigis, Hoffer Q, Holladay 1, Ladas Super, SRK/T, and Eom formulas using the 400-eye validation dataset were compared. The MedAE of the Eom formula (0.22 D) was significantly smaller than that of the other four formulas, except for the Barrett Universal II and Ladas Super formulas (0.24 D and 0.23 D, respectively). The IOL FPI of the Eom formula was 0.553, which ranked first, followed by the Ladas Super (0.474), Barrett Universal II (0.470), Holladay 1 (0.444), Hoffer Q (0.396), Haigis (0.392), and SRK/T (0.361) formulas. In conclusion, the Eom IOL power calculator developed in this study demonstrated similar or slightly better accuracy than the Barrett Universal II and Ladas Super formulas and was superior to the four traditional IOL power calculation formulas.

A Review of Intraocular Lens Power Calculation Formulas Based on Artificial Intelligence.

PURPOSE: The proper selection of an intraocular lens power calculation formula is an essential aspect of cataract surgery. This study evaluated the accuracy of artificial intelligence-based formulas. DESIGN: Systematic review. METHODS: This review comprises articles evaluating the exactness of artificial intelligence-based formulas published from 2017 to July 2023. The papers were identified by a literature search of various databases (Pubmed/MEDLINE, Google Scholar, Crossref, Cochrane Library, Web of Science, and SciELO) using the terms "IOL formulas", "FullMonte", "Ladas", "Hill-RBF", "PEARL-DGS", "Kane", "Karmona", "Hoffer QST", and "Nallasamy". In total, 25 peer-reviewed articles in English with the maximum sample and the largest number of compared formulas were examined. RESULTS: The scores of the mean absolute error and percentage of patients within ±0.5 D and ±1.0 D were used to estimate the exactness of the formulas. In most studies the Kane formula obtained the smallest mean absolute error and the highest percentage of patients within ±0.5 D and ±1.0 D. Second place was typically achieved by the PEARL DGS formula. The limitations of the studies were also discussed. CONCLUSIONS: Kane seems to be the most accurate artificial intelligence-based formula. PEARL DGS also gives very good results. Hoffer QST, Karmona, and Nallasamy are the newest, and need further evaluation.

Comparison of Pre- and Post-DMEK Keratometry and Total Keratometry Values for IOL Power Calculations in Eyes Undergoing Triple DMEK.

PURPOSE: To evaluate prediction accuracy of pre- and post-DMEK keratometry (K) and total keratometry (TK) values for IOL power calculations in Fuchs endothelial corneal dystrophy (FECD) eyes undergoing DMEK with cataract surgery (triple DMEK). METHODS: Retrospective cross-sectional multicenter study of 55 FECD eyes (44 patients) that underwent triple DMEK between 2019 and 2022 between two centers in USA and Europe. Swept-source optical coherence tomography biometry (IOLMaster 700) was used for pre- and post-DMEK measurements. K and TK values were used for power calculations with ten formulae (Barrett Universal II (BUII), Castrop, Cooke K6, EVO 2.0, Haigis, Hoffer Q, Hoffer QST, Holladay I, Kane, and SRK/T). Mean error, mean absolute error (MAE), standard deviation, and percentage of eyes within ±0.50/±1.00 diopters (D) were calculated. Studied formulae were additionally adjusted using a method published previously (IOLup1D Method), which increases the IOL power by 1D. While both eyes from the same patient were considered for descriptive statistics, we restricted to one eye per individual (44 eyes for statistical comparisons. RESULTS: MAEs for all formulae were lower for post-DMEK K and TK than pre-DMEK K and TK by an average of 0.24 and 0.47 D, respectively. The lowest MAE was 0.49 D for Kane using post-DMEK TK, and the highest MAE was 1.05 D for BUII using pre-DMEK TK. Most IOLup1D formulae had lower MAEs than pre-DMEK K and TK formulae. CONCLUSIONS: The IOLup1D Method should be used instead of pre-DMEK K and TK values for triple DMEK in FECD eyes. Using post-DMEK TK values for cataract surgery after DMEK provides better refractive accuracy than any of the three studied methods used for triple DMEK procedures.

Differences Between Keratometry and Total Keratometry Measurements in a Large Dataset Obtained With a Modern Swept Source Optical Coherence Tomography Biometer.

PURPOSE: This study aimed to explore the concept of total keratometry (TK) by analyzing extensive international datasets representing diverse ethnic backgrounds. The primary objective was to quantify the disparities between traditional keratometry (K) and TK values in normal eyes and assess their impact on intraocular lens (IOL) power calculations using various formulas. DESIGN: Retrospective multicenter intra-instrument reliability analysis. METHODS: The study involved the analysis of biometry data collected from ten international centers across Europe, the United States, and Asia. Corneal power was expressed as equivalent power and astigmatic vector components for both K and TK values. The study assessed the influence of these differences on IOL power calculations using different formulas. The results were analyzed and plotted using Bland-Altman and double angle plots. RESULTS: The study encompassed a total of 116,982 measurements from 57,862 right eyes and 59,120 left eyes. The analysis revealed a high level of agreement between K and TK values, with 93.98% of eyes exhibiting an absolute difference of 0.25 D or less. Astigmatism vector differences exceeding 0.25 D and 0.50 D were observed in 39.43% and 1.08% of eyes, respectively. CONCLUSIONS: This large-scale study underscores the similarity between mean K and TK values in healthy eyes, with rare clinical implications for IOL power calculation. Noteworthy differences were observed in astigmatism values between K and TK. Future investigations should delve into the practicality of TK values for astigmatism correction and their implications for surgical outcomes.

Refractive errors occurring with tilt of intraocular lenses.

A thin lens technique was developed to determine how the effective powers of toric monofocal intraocular lenses (IOLs) are influenced by tilt and the refractive errors associated with the tilt. A series of steps determined the effective power of the cornea at the IOL, the IOL power, the effective power of the tilted IOL, the correction required at the front of the eye and the power of an IOL that would compensate for the tilt. The correction was determined by starting at the ideal reduced image vergence at the IOL, backwards raytracing to obtain a reduced image vergence at the cornea, and subtracting the cornea power from this reduced image vergence. Examples are presented for different situations where the IOL is either tilted about the vertical or an oblique axis. Raytracing with a thick lens verified the accuracy of the technique.

Four-flanged polypropylene optic piercing technique for scleral fixation of multifocal intraocular lens.

BACKGROUND: To evaluate the feasibility of creating flanges using an optic piercing technique with a 6 - 0 polypropylene monofilament for scleral fixation of dislocated one-piece diffractive multifocal intraocular lenses (IOLs). STUDY DESIGN: Experimental study and case series. SUBJECTS: Optical bench test and eyes with IOL dislocation. METHODS: Two separate 6 - 0 polypropylenes were penetrated twice at the opposite peripheral optic of the TECNIS Synergy IOL (Johnson & Johnson Vision). The root mean square of the modulation transfer function (MTFRMS), at between + 1.00 and - 4.00 D of defocus, was measured in the TECNIS Synergy IOL both with and without optic piercing in the optical bench study. This case series included three eyes from two patients who underwent scleral-fixation of multifocal IOLs using the four-flanged polypropylene optic piercing technique. The postoperative corrected distance visual acuity (CDVA) at 4 m, the uncorrected near visual acuity (UNVA) at 40 cm, and IOL centration were evaluated. RESULTS: The optical bench test showed no differences in MTFRMS values measured in the TECNIS Synergy IOL, either with or without optic piercing at all defocuses. In all three case series, the postoperative CDVA at 4 m was 20/20 and UNVA at 40 cm was J1. Postoperative anterior segment photographs showed good centration of IOLs in all cases. CONCLUSION: The four-flanged polypropylene optic piercing technique for multifocal IOL scleral fixation can provide excellent clinical outcomes and IOL stability after surgery without diminishing the performance of the multifocal IOLs.

Determining specified intraocular lens powers when silicone oil is to be used in the vitreous chamber.

PURPOSE: To apply a theoretical approach to determining how specified intraocular lens (IOL) powers should change when vitreous oil substitution is combined with IOL implantation. SETTING: University laboratory, private Ophthalmological practice. DESIGN: Theoretical raytracing. METHODS: Raytracing was done backwards from the retina with equi-convex 20 diopters (D) and 25 D IOLs, of refractive index 1.5332, to the object side of the anterior IOL surface. The 1.336 vitreous index was replaced with a high index 1.405 silicone oil. Raytracing was repeated with increase in specified power, that power as if 1.336 index was still surrounding the IOL, so that the object reduced vergence on the anterior side of the lens matched that of the original IOL power. This was done for a range of lens shapes from plano-convex (front surface flat), through equi-convex, to plano-convex (back surface flat), and for a range of axial lengths. The true power, the power with 1.336 index on the object side and silicone oil on the image side, was also determined. RESULTS: Replacing vitreous by silicone oil increases the necessary specified IOL power. This increase varies from approximately 14% for flat back surfaces, to 40% for equi-convex lenses, to 80% for flat front surface IOLs. True powers increase by about 15% across the range of IOL shapes. In terms of percentages, effects of changing the original IOL power and the axial length are small. CONCLUSIONS: When silicone oil is to remain in an eye after cataract surgery, biconvex IOLs require much higher specified powers than convex-plano IOLs.

Accuracy of 24 IOL Power Calculation Methods.

PURPOSE: To scrutinize the accuracy of 24 intraocular lens (IOL) power calculation formulas in unoperated eyes. METHODS: In a series of consecutive patients undergoing phacoemulsification and implantation of the Tecnis 1 ZCB00 IOL (Johnson & Johnson Vision), the following formulas were evaluated: Barrett Universal II, Castrop, EVO 2.0, Haigis, Hoffer Q, Hoffer QST, Holladay 1, Holladay 2, Holladay 2 (AL Adjusted), K6 (Cooke), Kane, Karmona, LSF AI, Naeser 2, OKULIX, Olsen (OLCR), Olsen (standalone), Panacea, PEARL-DGS, RBF 3.0, SRK/T, T2, VRF, and VRF-G. The IOLMaster 700 (Carl Zeiss Meditec AG) was used for biometric measurements. With optimized lens constants, the mean prediction error (PE) and its standard deviation (SD), the median absolute error (MedAE), the mean absolute error (MAE), and the percentage of eyes with prediction erros within ±0.25, ±0.50, ±0.75, ±1.00, and ±2.00 D were analyzed. RESULTS: Three hundred eyes of 300 patients were enrolled. The heteroscedastic method revealed statistically significant differences (P < .05) among formulas. Newly developed methods such as the VRF-G (standard deviation [SD] ±0.387 D), Kane (SD ±0.395 D), Hoffer QST (SD ±0.404 D), and Barrett Universal II (SD ±0.405) were more accurate than older formulas (P < .05). These formulas also yielded the highest percentage of eyes with a PE within ±0.50 D (84.33%, 82.33%, 83.33%, and 81.33%, respectively). CONCLUSIONS: Newer formulas (Barrett Universal II, Hoffer QST, K6, Kane, Karmona, RBF 3.0, PEARL-DGS, and VRF-G) were the most accurate predictors of postoperative refractions. [J Refract Surg. 2023;39(4):249-256.].

Intraocular Lens Power Calculations in Keratoconus Eyes Comparing Keratometry, Total Keratometry, and Newer Formulae.

PURPOSE: To compare the utility of keratometry vs total keratometry (TK) for intraocular lens power calculations in eyes with keratoconus (KCN) using KCN and non-KCN formulae. DESIGN: Retrospective cohort study. METHODS: This study was conducted at 2 academic centers and included 87 eyes in 67 patients who underwent cataract surgery between 2019 and 2021. Biometry measurements were obtained using a swept-source optical coherence tomography biometer (IOL Master 700). Refractive prediction errors, including root mean square error (RMSE), were calculated for 13 formulae. These included 4 classical formulae (Haigis, Hoffer Q, Holladay 1 [H1], and SRK/T), 5 new formulae (NF) (Barrett Universal II [BU2], Cooke K6, EVO 2.0, Kane, and Pearl-DGS), 3 KCN formulae (BU2 KCN: M-PCA, BU2 KCN: P-PCA, and Kane KCN), and H1 with equivalent keratometry reading values (H1-EKR). Formulae were ranked by RMSE. Friedman analysis of variance with post hoc analysis and H-testing was used for statistical significance testing. RESULTS: KCN formulae had the lowest RMSEs in all eyes, and BU2 KCN:M-PCA performed the best among KCN formulae in all subgroups. In eyes with severe KCN, if TK values are unavailable, the BU2 KCN: P-PCA performed better than the top-ranked non-KCN formula (SRK/T). In eyes with nonsevere KCN, if TK values are unavailable, EVO 2.0 K was statistically superior to the next competitor (Kane K). H1-EKR had the highest RMSE. CONCLUSIONS: KCN formulae and TK are useful for intraocular lens power calculations in KCN eyes, especially in eyes with severe KCN. The BU2 KCN: M-PCA using TK values performed best for eyes with all severities of KCN. For eyes with nonsevere KCN, the EVO 2.0 TK or K can also be used.

Influence and predictive value of optional parameters in new-generation intraocular lens formulas.

PURPOSE: To evaluate the accuracy of various variations of new-generation multivariate intraocular lens (IOL) power calculation using the Barrett Universal II, Castrop, Emmetropia Verifying Optical 2.0, Hill-Radial Basis Function 3.0, Kane, and PEARL-DGS formulas with and without optional biometric parameters. SETTING: Tertiary care academic medical center. DESIGN: Retrospective case series. Single-center study. METHODS: Inclusion of patients after uneventful cataract surgery implanting AU00T0 IOLs. Data from one eye per patient were randomly included. Eyes with a corrected distance visual acuity worse than 0.1 logMAR were excluded. IOLCON-optimized constants were used for all formulas other than the Castrop formula. The outcome measures were prediction error (PE) and absolute prediction error (absPE) for the 6 study formulas. RESULTS: 251 eyes from 251 patients were assessed. Excluding lens thickness led to statistically significant differences in absPE in several formulas. Leaving out horizontal corneal diameter did not impact absPE in several formulas. Differences in PE offset were observed between the various formula variations. CONCLUSIONS: When using multivariate formulas with an A-constant, including certain optional parameters is vital for optimal refractive results. Formula variations excluding certain biometric parameters need specifically optimized constants and do not perform similarly when using the constant of the respective formula using all parameters.

Surgeons need to know more about intraocular lens design for accurate power calculation.

Improvement in biometry and formulas has raised the bar for accurate intraocular lens (IOL) power calculation. However, when we look closely at the performance of a specific IOL model, we often find that the prediction error varies with the implant power. This phenomenon has no explanation other than that the optic design of the IOL has shifted over the power range, thereby disrupting the assumptions of the calculations. By this report, we call the industry to be more transparent and disclose the basic information about the IOL design that is important for accurate IOL power calculation. The relevant information concerns the refractive index, the central optic thickness, the anterior and posterior curvature radii, the toricity location, the spherical aberration, and haptic angulation. The goal is to predict possible shifts in principal planes or IOL position over the power range causing a refractive surprise if not corrected for.

Standard vs total keratometry for intraocular lens power calculation in cataract surgery combined with DMEK.

PURPOSE: To compare the prediction accuracy of standard keratometry (K) and total keratometry (TK) for intraocular lens (IOL) power calculation in eyes undergoing combined cataract surgery and Descemet membrane endothelial keratoplasty (triple DMEK). SETTING: Tertiary care academic referral center. DESIGN: Retrospective case series. METHODS: Review of 83 eyes (63 patients) that underwent triple DMEK between 2019 and 2021. Biometry measurements were obtained using a swept-source optical biometer (IOLMaster 700). 63 eyes were used for statistical analysis. Mean error, mean absolute error (MAE), SD, median absolute error, maximum absolute error, root mean squared prediction error, and the percentage of eyes within prediction errors of ±0.50 diopters (D) and ±1.00 D were calculated for 9 multivariate and third-generation formulas using K and TK values (Barrett Universal II, Yeo EVO 2.0, Cooke K6, Kane, Pearl-DGS, Haigis, Holladay 1, Hoffer Q, and SRK/T). Formulas were additionally tested by using the prediction for an IOL power 1 D below the IOL used (IOLup1D). RESULTS: For all formulas, MAE was lower for K than for TK by an average of 0.21 D. The lowest MAE value observed was 0.67 D for "adjusted" SRK/T using K, and the highest MAE values observed were 1.24 D and 1.24 D for nonadjusted Hoffer Q and Haigis using TK, respectively. Overall, lower MAE values were observed for multivariate formulas and SRK/T. CONCLUSIONS: In triple DMEK eyes, the prediction accuracy of K was higher than that of TK. The most accurate formulas were SRK/T and multivariate formulas using K with the IOLup1D adjustment.

The 10,000 Eyes Study: Analysis of Keratometry, Abulafia-Koch regression transformation, and Biometric Eye Parameters Obtained With Swept-Source Optical Coherence Tomography.

PURPOSE: To analyze Abulafia-Koch regression (AKRT), anterior and posterior astigmatism (K and TK), and evaluate biometry data in a large population. DESIGN: Retrospective cross-sectional study. METHODS: This multicenter (2 tertiary care centers) study analyzed datasets acquired between 2017 and 2020. Axial length (AL), corneal front and back radii (including meridians for K and TK conversion), horizontal corneal diameter, anterior chamber depth, lens thickness, and central corneal thickness were measured using telecentric keratometry and swept-source optical coherence tomography-based biometry (IOLMaster 700; Carl Zeiss Meditec AG). Cooke-modified axial length (CMAL) and AKRT were calculated. Difference vectors between K and TK astigmatism and between AKRT and TK astigmatism were compared. RESULTS: A total of 10,300 eyes from 6388 patients were assessed. Difference vectors for K and TK were significantly smaller than for AKRT and TK. K measurement showed a configuration of 51.49% of with-the-rule astigmatism and 30.51% against-the-rule astigmatism, TK measurement showed a configuration of 41.60% of with-the-rule astigmatism and 40.21% against-the-rule astigmatism. Mean total astigmatism was -0.94 ± 0.74 dpt. Mean values for AL and CMAL were 23.70 ± 1.39 mm and 23.70 ± 1.34 mm, respectively. Anterior chamber depth, lens thickness, horizontal corneal diameter, AL, and age were all correlated with each other. CONCLUSION: Astigmatism analysis showed less difference between K and TK than between AKRT and TK. There were significantly fewer eyes with with-the-rule astigmatism and more eyes with against-the-rule astigmatism configuration in TK-derived than in K-derived keratometry. The study provides data on gender and generational differences in biometry. Significant intersexual differences in AL and CMAL were observed, with CMAL providing lower standard deviation compared with AL.

Phase â /â ¡, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension.

PURPOSE: To perform a phase Ⅰ/Ⅱ evaluation of an H-1337 ophthalmic solution in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). DESIGN: This was a phase I/II, randomized, double-masked, vehicle-controlled, dose-response study conducted at 6 private practice sites in the United States. The study was registered with clinicaltrials.gov as NCT03452033. PARTICIPANTS: Eighty-seven subjects with bilateral POAG or OHT were enrolled. METHODS: After washout of ocular hypotensive medications as required, the subjects were randomized to receive either the H-1337 ophthalmic solution at 0.06%, 0.2%, and 0.6% or its vehicle twice daily unilaterally in the study eye for the first 3 days and then twice daily in both eyes from day 4 to 28. MAIN OUTCOME MEASURES: The primary efficacy end point was the mean change in intraocular pressure from baseline (day 0) for each group on day 28 at hour 4 compared with the vehicle. RESULTS: In the primary efficacy end point, i.e., mean change from the baseline on day 28 at hour 4, the mean change from the baseline was - 4.45 ± 3.801, - 5.16 ± 3.114, - 4.93 ± 3.110, and - 0.39 ± 2.355 in the 0.06%, 0.2%, and 0.6% H-1337 and vehicle groups, respectively. The difference between each active group and the vehicle group was statistically significant (P < 0.0001). Treatment-emergent adverse events (TEAEs) occurred in 49% of subjects who received H-1337 (range, 41% [0.2% arm]-64% [0.6% arm] across the H-1337 arms) and 18% of subjects who received the vehicle. The majority of TEAEs were mild in severity; 3 subjects who received H-1337 had a TEAE of moderate intensity (instillation site erythema, blurred vision, and muscle strain). CONCLUSIONS: The H-1337 ophthalmic solution showed clinically and statistically significant ocular hypotensive activity and was well tolerated, with a relatively low incidence of hyperemia. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.