Clinical performance after implantation of an EDOF intraocular lens in the dominant eye and a presbyopia-correcting intraocular lens in the nondominant eye.

PURPOSE: To evaluate subjective and objective outcomes after combined implantation of an extended depth-of-focus (EDOF) intraocular lens (IOL) and a combined technology multifocal lens (CT-IOL). SETTING: 2 clinical practices (Carolina Eyecare Physicians, Center For Sight) in the United States. DESIGN: Prospective, unmasked, multicenter, nonrandomized bilateral eye study. METHODS: Patients interested in reducing their dependence on spectacles were implanted with an EDOF IOL in the dominant eye and a CT-IOL in the nondominant eye. Refractive and visual acuity (VA) data at various distances (4 m, 66 cm, 40 cm, and 33 cm) were collected 3 months postsurgery, along with the distance-corrected binocular defocus curve and responses to questionnaires related to spectacle independence, visual disturbances, and overall visual function. RESULTS: Data from 37 participants were analyzed. The distance-corrected binocular defocus curve showed a mean VA better than 0.1 logMAR (20/25) at all vergences from +1.00 to -2.50 diopters (D). 36 participants (97%) had an uncorrected binocular VA of 0.3 logMAR or better, at all test distances. 70% of participants (26/37) reported never wearing spectacles at any distance, and 84% (31/37) were "completely" or "mostly" satisfied with their overall vision after surgery. Halos were the disturbance reported most frequently and reported as most bothersome, with difficulty driving at night the most common visual function issue. Difficulty reading was the next most reported issue. Overall eyesight was rated as "excellent" or "good" by 92% (34/37) of participants. CONCLUSIONS: This combined EDOF/CT-IOL approach was well-tolerated by participants and provided some potential benefits relative to bilateral implantation of either lens.

Comparing Visual Performance and Subjective Outcomes with an Enhanced Monofocal Intraocular Lens When Targeted for Emmetropia or Monovision.

Purpose: To evaluate relative visual performance and subjective outcomes after implantation of the TECNIS Eyhance™ intraocular lens (IOL) targeted for bilateral emmetropia or monovision. Methods: This was a prospective, single-center randomized, patient-masked trial. Patients were implanted with the enhanced IOL targeted for bilateral emmetropia or slight monovision (-0.75 D in the non-dominant eye). At 3 months the binocular visual acuity (VA) was measured at distance, intermediate and near, along with low contrast VA in photopic and mesopic conditions, and the distance corrected defocus curve. Questionnaires related to spectacle independence, satisfaction, visual symptoms, and functional vision were administered. Results: Data from 71 subjects (34 Emmetropia, 37 Monovision) were analyzed. There was no difference in the mean uncorrected distance VA (p = 0.11), but uncorrected intermediate and near VAs were one line better in the Monovision group (p = 0.02 and 0.01, respectively). Mesopic and photopic low contrast VA were similar between groups. There was a trend for less difficulty and higher satisfaction with near and intermediate vision in the Monovision group, but no significant differences in any of the subjective questionnaires. Difficulty reading was the most reported concern in both groups, though 93% of all subjects reported "little" or "no" difficulty with daily activities. Overall, 82% of subjects were "completely" or "very" happy with their lens choice. Conclusion: Using this enhanced IOL with slight monovision in the non-dominant eye increased intermediate and near VA with no apparent effect on low contrast distance VA, subjective visual quality, or satisfaction.

Visual Outcomes, Quality of Vision, Patient Satisfaction and Spectacle Independence After Bilateral Implantation of the Synergy™ Intraocular Lens.

Purpose: To evaluate vision, visual quality, patient satisfaction and spectacle independence after bilateral implantation of the TECNIS Synergy™ intraocular lens. Setting: Two clinical practices in the USA. Design: Ambispective unmasked non-randomized clinical trial. Methods: Patients with a history of uneventful bilateral femtosecond laser assisted cataract surgery with the study IOL implanted, targeted for emmetropia, at least 3 months prior to the study visit were enrolled. Monocular and binocular visual acuity (VA) were measured at distance, intermediate and near, along with binocular mesopic VA. Low contrast binocular VA and reading speed in mesopic and photopic conditions were also measured. Patient satisfaction, spectacle independence, visual symptoms, and functional vision questionnaires were completed. Results: Results from 52 subjects were available for analysis. Mean binocular unaided visual acuity was ~0.1 logMAR (20/20) from distance to 33 cm, with 81% of subjects having 0.2 logMAR (20/25) vision or better at all test distances and 92% reporting never needing glasses at any distance. Average reading speed at 40 cm was only 10 words/minute slower in dim light (p = 0.03). Mesopic and low contrast acuity appeared good. Halos were the most frequent and bothersome visual disturbances, with the greatest effect on driving at night. Eighty-eight percent of subjects reported being "completely" or "mostly" satisfied with their overall unaided vision. Conclusion: This hybrid technology IOL provided a range of binocular visual acuity from distance to 33 cm and good functional vision, even in dim light. Patients should be advised of the likelihood of visual disturbances, particularly halos.

Visual outcomes, satisfaction, and spectacle independence with a nondiffractive extended vision intraocular lens targeted for slight monovision.

PURPOSE: To evaluate vision, satisfaction, and spectacle independence of the AcrySof IQ Vivity intraocular lens when the nondominant eye is targeted for slight myopia. SETTING: 1 clinical practice in the United States. DESIGN: Prospective unmasked nonrandomized clinical trial. METHODS: Patients presenting for cataract surgery interested in reducing their dependence on spectacles were enrolled, with the dominant eye targeted for emmetropia and the nondominant eye targeted for slight monovision (-0.50 diopters [D]). Visual disturbances, satisfaction, and spectacle independence were evaluated. Visual acuity (VA) was tested at distance (4 m), intermediate (66 cm), and near (40 cm) at 3 months postoperatively when uncorrected, with both eyes corrected to emmetropia and with 1 eye adjusted for monovision. 2 binocular defocus curves were also collected under the latter 2 conditions. RESULTS: Data from 31 patients were analyzed. The mean refractive spherical equivalent was 0.45 D more myopic in the nondominant eye, resulting in worse uncorrected VA at distance but better uncorrected VA at near. The binocular defocus curve with monovision showed significantly better VA from -2.0 to -3.0 D, and patients reported less need for spectacles (and better vision) at near than reported with binocular emmetropia. Glare, blurred vision, and starbursts were the most reported visual disturbances. Although not correlated with the difference in refraction, glare and blurred vision were significantly correlated with overall satisfaction. CONCLUSIONS: Implanting this IOL with a target of slight myopia in the nondominant eye appears to be a viable way to improve near vision, although with an increased potential for visual disturbances.

The Effects of Angle Kappa on Clinical Results and Patient-Reported Outcomes After Implantation of a Trifocal Intraocular Lens.

Purpose: To objectively determine if angle kappa materially influenced clinical outcomes or patient-reported satisfaction and visual quality of patients implanted with a trifocal intraocular lens (IOL). Methods: This was a non-interventional study of clinical outcomes. Subjects were patients choosing to be bilaterally implanted with a trifocal IOL (PanOptix®) who were then evaluated 3 months postoperative. Angle kappa (AK) was measured before surgery and at the 3-month visit. The 3-month visit included a manifest refraction, and measurement of uncorrected and distance corrected acuity at 4 m, 60 cm and 40 cm. Visual quality and satisfaction questionnaires were also administered. Results: Data from 56 eyes of 28 subjects were analyzed; 26 eyes had an AK magnitude <0.3 mm, 14 had an AK from 0.3 mm to less than 4 mm and 16 had an AK ≥0.4 mm. Neither visual disturbances (eg, glare, halos, starbursts), satisfaction nor spectacle dependence were correlated to the magnitude of angle kappa. The magnitude of postoperative AK was significantly lower than preoperative (0.24 ± 0.12 mm vs 0.30 ± 0.16 mm, p < 0.01). Conclusion: The magnitude of preoperative Angle Kappa had no apparent effect on the refractive, visual acuity or subjective (visual disturbances, quality of vision, satisfaction) clinical outcomes with this trifocal IOL. The magnitude of angle kappa was significantly lower after surgery.

Safety and efficacy of nepafenac punctal plug delivery system in controlling postoperative ocular pain and inflammation after cataract surgery.

PURPOSE: To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) after cataract surgery. SETTING: Three U.S. clinical sites. DESIGN: Prospective, multicenter, randomized (2:1), parallel-arm, double-masked, placebo-controlled, phase II pilot study. METHODS: Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively. RESULTS: There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 [69%] vs 6/16 [38%] at 3 days, P = .038; and 24/36 [67%] vs 5/16 [31%] at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 [52%] vs 0/14 [0%] in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 [50%] vs 3/16 [19%] in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group. CONCLUSIONS: The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery.

Cataract surgery after myopic laser in situ keratomileusis: objective analysis to determine best formula and keratometry to use.

PURPOSE: To objectively determine which formula/keratometry combination was best for calculating intraocular lens (IOL) sphere power in eyes with a history of myopic laser in situ keratomileusis (LASIK). SETTING: One practice in the United States. DESIGN: Retrospective, unmasked, nonrandomized chart review. METHODS: Consecutive patients undergoing cataract surgery after previous myopic LASIK were included. Eyes had to have a postoperative refraction at least 3 weeks postoperatively. IOL power was calculated with the ASCRS online postrefractive IOL calculator using anterior keratometry and recalculated using total corneal power (TK). The accuracy of treatment was calculated and compared between different formulas and keratometry methods including intraoperative aberrometry (IA). RESULTS: Data from 101 eyes, 44 of which had TK available, were analyzed. Using TK, the Wang-Koch-Maloney formula had the highest percentages of eyes with expected spherical equivalent refractive errors within 0.50 diopter (D) and 1.00 D of plano (57% and 87%, respectively). With anterior keratometry, the Barrett True-K formula had the highest percentages (64% and 92%, respectively) but was not significantly better than the Wang-Koch-Maloney formula, with expected errors within ±0.50 and ±1.00 D (P > .2, McNemar test). Expected sphere results based on IA were not significantly different than for Barrett True-K within ±0.50 D or within ±1.00 D (P > .2, McNemar test). CONCLUSIONS: Using TK in existing post-LASIK formulas did not seem beneficial. The formulas might have to be optimized for use with TK. The best expected results were obtained with the Barrett True-K and Haigis-L formulas using anterior keratometry. IA did not seem to materially improve results.

Five-Year Outcomes Prospective Study of Two First-Generation Trabecular Micro-Bypass Stents (iStent®) in Open-Angle Glaucoma.

PURPOSE: To assess 5-year effectiveness and safety of 2 iStent® trabecular micro-bypass stents in eyes with open-angle glaucoma (OAG) not controlled on 1 medication. MATERIALS AND METHODS: This prospective, interventional, single-arm, multi-surgeon study (NCT #1252862, clinicaltrials.gov) enrolled eyes with OAG, preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 ocular hypotensive medication, and 22-38 mmHg after medication washout. Eyes underwent standalone implantation of 2 iStent devices and were followed through 60 months postoperatively. Efficacy was quantified by mean diurnal IOP and medication usage. Efficacy endpoints included the proportion of eyes with ≥20% IOP reduction versus baseline unmedicated IOP (primary efficacy), and the proportion of eyes with IOP ≤18 mmHg (secondary efficacy) without medication or secondary glaucoma surgery. Safety parameters included visual acuity, cup-to-disc ratio, visual field, and complications and adverse events. RESULTS: Preoperative mean IOP on 1 medication was 20.6 ± 2.0 mmHg and post-washout unmedicated IOP was 24.1 ± 1.4 mmHg (n = 39). At 5 years postoperative, medication-free mean diurnal IOP reduced to 14.5 ± 2.2 mmHg, constituting a 40% decrease versus preoperative washed-out IOP (p < .0001). In addition, this 5-year medication-free IOP constituted a 30% decrease versus preoperative IOP on 1 medication (p < .0001). At Month 60, 89.7% (26/29) of eyes achieved the primary efficacy endpoint of ≥20% IOP reduction versus baseline unmedicated IOP, and 86.2% (25/29) of eyes achieved the secondary efficacy endpoint of IOP ≤18 mmHg, without medication or secondary glaucoma surgery. Throughout follow-up, 89.7-91.3% of eyes were on no medications. Favorable safety included no secondary glaucoma surgeries, minimal adverse events, and stable visual acuity, cup-to-disc ratio, and visual fields through 5 years postoperative. CONCLUSIONS: This prospective interventional study demonstrates persistent 5-year reductions in IOP and freedom from medications, together with favorable safety, following implantation of 2 first-generation trabecular micro-bypass stents in eyes with OAG on 1 preoperative medication.

Visual Acuity, Defocus Curve, Reading Speed and Patient Satisfaction with a Combined Extended Depth of Focus Intraocular Lens and Multifocal Intraocular Lens Modality.

PURPOSE: To evaluate the vision, defocus curve, reading speed and patient satisfaction after implantation of an extended depth of focus (EDOF) IOL in one eye and a diffractive multifocal in the fellow eye. SETTING: One clinical practice in the USA. DESIGN: Prospective unmasked non-randomized clinical trial. METHODS: Subjects presenting for routine cataract surgery interested in reducing their dependence on spectacles were enrolled. Study endpoints included uncorrected and distance-corrected binocular distance (4 m), intermediate (66 cm) and near (40 cm) visual acuity at 3 months. Additional endpoints included the residual refraction, spectacle independence, overall satisfaction with vision, visual symptoms, reading speed and defocus curve. RESULTS: With a best distance correction, 77% (30/39) of subjects had 20/25 or better VA at distance, intermediate and near and nearly all subjects had 20/32 or better VA at all three distances. Defocus curve results showed mean continuous vision of 20/25 or better from plano to -2.50 D. Nearly 80% (31/39) of subjects had 20/25 visual acuity from 0.00 D to -2.50 D. The critical print size was between 0.3 and 0.4 logMAR (20/40 to 20/50 Snellen Equivalent). Spectacle independence was 100% at distance, 95% at intermediate and approximately 70% at near. The percentage of subjects who were "not at all" or "slightly" bothered by visual disturbances ranged from 64% (16/25) for Halos to 88% (22/25) for Starbursts. CONCLUSIONS: EDOF/bifocal IOL blended implantation results in at least 20/25 mean visual acuity from distance to near with good spectacle independence and low reports of severe visual disturbances.

Evaluating Rotational Stability of an Extended Depth of Focus Toric Intraocular Lens Using a Slit Lamp and Image-Based Analysis.

PURPOSE: To evaluate the rotational stability of a toric extended depth of focus (EDOF) intraocular lens (IOL), using either slit lamp evaluation or image-processing software. SETTING: Three clinical practices in the USA. DESIGN: Prospective unmasked randomized clinical trial. METHODS: Subjects presenting for routine cataract surgery that were interested in improved near vision received toric EDOF lenses (TECNIS Symfony® Toric) in both eyes. The measures of interest in the current analysis were the change in orientation of the IOL between 1 day, 1 month and 3 months postoperative. Orientation was measured at the microscope on the day of surgery, and with the slit lamp at all other visits. Day 1, 1-month and 3-month images of the lens orientation were captured with a slit lamp camera. Differences in orientation were recorded and analyzed. RESULTS: A total of 150 eyes had IOL orientation data available. Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees. The percentage of lenses exhibiting rotation of ≤5 degrees between any measured time points was 97% or higher. Results were similar, but significantly more variable, when IOL orientation was measured at the slit lamp. CONCLUSION: The toric EDOF lens evaluated here demonstrated rotational stability that exceeded the prior ANSI standard. The best method to determine IOL orientation changes was through image analysis. .

Comparing Combination Drop Therapy to a Standard Drop Regimen After Routine Cataract Surgery.

PURPOSE: To evaluate the efficacy of a combined steroid/antibiotic/non-steroidal anti-inflammatory drop relative to a regimen of multiple drops after cataract surgery. SETTING: Single clinical practice in the USA. DESIGN: Prospective randomized contralateral eye study. METHODS: Subjects presenting for bilateral cataract surgery were enrolled with contralateral eyes randomly assigned to one of the two groups. Test eyes received a combination therapy (prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac sodium 0.075%) while control eyes received the same medications in separate drops (bromfenac sodium was 0.07%). Subjects were examined 1, 15 and 30 days after surgery. Visual acuities were measured, along with the refraction, intraocular pressure, patient pain and satisfaction, macular thickness and corneal pachymetry. The primary measure of interest was the change in macular thickness from baseline to the 15- and 30-day visits. The frequency and severity of reported ocular adverse events were tabulated for each group and compared. RESULTS: Thirty-three subjects completed the study. Changes in central macular thickness were similar between groups, with only one control eye exhibiting significant macular edema. No differences in visual acuity, corneal edema, cells or flare were observed between groups. There were eight mild adverse events reported for all eyes of all subjects; the difference in the number of eyes experiencing adverse events was not statistically significantly different between groups (p ≥ 0.05 for all comparisons). While subjective symptoms were similar, all subjects indicated that they preferred the combination drop. CONCLUSION: A combination drop showed similar efficacy to multiple drops and was overwhelmingly preferred by subjects.

Defocus Curve and Patient Satisfaction with a New Extended Depth of Focus Toric Intraocular Lens Targeted for Binocular Emmetropia or Slight Myopia in the Non-Dominant Eye.

PURPOSE: To evaluate the defocus curve and patient satisfaction after implantation of an extended depth of focus (EDOF) toric IOL when both eyes were targeted for emmetropia and when the non-dominant eye was targeted for mini monovision (-0.50D). METHODS: A prospective unmasked randomized clinical trial in three clinical practices in the USA. Subjects presenting for routine cataract surgery were assigned to one of two groups, both receiving bilateral toric EDOF lenses. One group had the non-dominant eye targeted for slight myopia (-0.50D). Measures of interest were the postoperative defocus curve and reported patient satisfaction and visual disturbances. RESULTS: Questionnaire and defocus curve data were available from 37 subjects in the Emmetropia group, while the mini monovision group included questionnaire data from 39 subjects and valid defocus curve data from 14 subjects. Mini monovision subjects had significantly better VA (a half line to a line better, p < 0.05), from a defocus of -1.50 D to -3.00 D. Reported spectacle wear and satisfaction were not significantly different between groups at any distance, but more patients in the mini monovision group reported the ability to function comfortably without glasses at near and overall (near p = 0.02, overall p < 0.01). Halos and starbursts were the two phenomena reported most often for both groups, with reported starbursts slightly more common in the mini monovision group. CONCLUSIONS: A slightly myopic correction in the non-dominant eye improved binocular near vision by 0.5 to 1.0 lines based on defocus curve data. Patients reported better functional vision, but with a slight increase in reported starbursts in the mini monovision group.

Evaluating the relative value of intraoperative aberrometry versus current formulas for toric IOL sphere, cylinder, and orientation planning.

PURPOSE: To retrospectively review toric intraocular lens (IOL) outcomes and compare actual results to those expected from preoperative calculations and intraoperative aberrometry (IA) in normal eyes. SETTING: Carolina Eyecare Physicians, Mt. Pleasant, South Carolina, USA. DESIGN: Retrospective data review of earlier clinical trial data. METHODS: Toric IOL planning data and results were obtained from two previous clinical studies of normal eyes receiving toric IOL implants. Back-calculation techniques were used to estimate expected residual refractive sphere and cylinder for preoperative and IA calculations. RESULTS: Toric IOL planning data and clinical outcomes for 132 eyes receiving two different toric IOLs were analyzed. The mean spherical equivalent refractions expected with preoperative planning and IA were not statistically significantly different (P = .44), but a higher percentage of eyes within ±0.50 D of the intended spherical refraction was expected with preoperative calculations (P = .05). The mean expected residual refractive astigmatism based on preoperative calculations was significantly lower than for IA (P < .001), with more eyes expected to have 0.50 D or less of residual refractive astigmatism. CONCLUSION: The use of current-generation formulas for sphere power and toric IOL planning in normal eyes seems sufficient to produce clinical outcomes with toric IOLs that are as good or better than those achieved using IA.

Extended depth-of-focus toric intraocular lens targeted for binocular emmetropia or slight myopia in the nondominant eye: Visual and refractive clinical outcomes.

PURPOSE: To compare the visual and refractive outcomes with a diffractive toric extended depth-of-focus (EDOF) intraocular lens (IOL) when both eyes are targeted for emmetropia and the nondominant eye is targeted for slight myopia. SETTING: Three clinical practices, United States. DESIGN: Prospective case series. METHODS: Patients having routine cataract surgery with bilateral Tecnis Symfony toric EDOF IOL implantation were assigned to 1 of 2 groups. In 1 group, the nondominant eye was targeted for -0.50 diopter (D) (mini-monovision). Assessments included uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (4 m), intermediate (66 cm), and near (40 cm) and the postoperative residual refractive error. RESULTS: Forty patients were enrolled in each group, with 1 dropout. The mean postoperative residual refractive astigmatism was 0.25 D in both groups, with no statistically significant difference. The mean residual refractive astigmatism was 0.50 D or lower in 92% of eyes (72/78) in the mini-monovision group and 95% of eyes (74/78) in the emmetropia group 3 months postoperatively. The mini-monovision group had slightly worse uncorrected visual acuity at 4 m than the emmetropia group (0.16 versus 0.09; P = .002) but better uncorrected acuity at 40 cm (0.25 versus 0.34; P < .001). Binocular uncorrected acuity was not statistically significantly different between groups at 4 m (-0.03 versus -0.01; P = .33) or 66 cm (0.06 versus 0.04; P = .34) but was statistically significant at 40 cm (0.25 versus 0.19; P = .03). CONCLUSIONS: The EDOF toric IOL provided functional distance, intermediate, and near vision. A slight monovision approach appears to improve near visual acuity.

Correcting astigmatism at the time of cataract surgery: Toric IOLs and corneal relaxing incisions planned with an image-guidance system and intraoperative aberrometer versus manual planning and surgery.

PURPOSE: To compare the outcomes of the combination of an image-guided system and intraoperative aberrometer with the surgeon's standard of care in correcting astigmatism using toric intraocular lenses (IOLs) or corneal incisions. SETTING: Single site in United States. DESIGN: Prospective case series. METHODS: Contralateral eyes of patients having uncomplicated bilateral cataract surgery and astigmatism correction were randomly assigned to Group A or Group B. Group A received the surgeon's preferred standard of care. Group B had preoperative planning using an image-guidance system (VERION), intraoperative aberrometry (ORA System with VerifEye+), and femtosecond laser-assisted cataract surgery. The primary endpoint was the residual refractive astigmatism at 3 months. RESULTS: Thirty-eight eyes were treated with toric IOLs and 40 eyes with corneal astigmatic incisions. On average, toric IOLs resulted in almost 0.25 diopter (D) less cylinder than corneal astigmatic incisions (P < .01), with no difference between groups (P = .41). There was no statistically significant difference in the mean spherical equivalent refraction by group (P = .51). At 3 months, the IOL in 4 eyes (11%) (2 in Group A and Group B each) was more than 10 degrees of absolute orientation from the intended orientation. The mean keratometry was 0.16 D higher with the image-guided system compared with optical biometry (Lenstar). The vector difference between the 2 measurements was 0.5 D or lower in all eyes. CONCLUSIONS: The combined use of an image-guided system and intraoperative aberrometer did not significantly improve outcomes compared with the surgeon's standard of care. Based on keratometry, there was good agreement in corneal astigmatism measurements between the image-guided system and the optical biometer.

Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study.

PURPOSE: To compare the safety and efficacy of IBI-10090 anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu) with those of prednisolone acetate 1.0% ophthalmic drops in treating inflammation after cataract surgery. SETTING: Eleven centers in the United States. DESIGN: Prospective randomized open-label multicenter trial. METHODS: Patients were randomized 2:1 to receive a 5 µL injection of 517 µg IBI-10090 in the anterior eye chamber or topical prednisolone 1.0% drops (1 drop 4 times daily for 3 weeks). The postoperative follow-up was 90 days. The primary outcome was safety, evaluated by the incidence and severity of adverse events. Exploratory measures were anterior chamber cell, anterior chamber flare, and anterior chamber cell-flare clearing. RESULTS: One hundred twenty-six IBI-10090 patients and 55 prednisolone patients were included in the safety analysis. Two serious adverse events unrelated to treatment were reported. The decrease in endothelial cell density was not significantly different between groups. The most common adverse events were increased intraocular pressure (11.1%), iritis (6.3%), and systemic (7.9% IBI-10090 group; 10.9% prednisolone group). By 8 days postoperatively, 51.6% of IBI-10090 eyes and 50.9% of prednisolone eyes had anterior chamber cell clearing; more than 98% of eyes had clearing at 90 days. The anterior chamber flare and anterior chamber cell-flare clearing results were similar. Of IBI-10090 patients, 68.7% strongly agreed that not having to use eyedrops was very convenient; 39.2% using prednisolone 1.0% strongly stated they would have preferred dropless therapy. CONCLUSION: The safety and efficacy of IBI-10090 and prednisolone 1.0% were similar, with IBI-10090 preferred over drops.

Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up.

PURPOSE: To evaluate the long-term intraocular pressure (IOP)-lowering effect and safety parameters following treatment with two trabecular micro-bypass stents and topical prostaglandin in phakic eyes with open-angle glaucoma (OAG) not controlled on two preoperative medications. METHODS: This prospective, single-arm, unmasked study enrolled 39 qualified phakic eyes with OAG not controlled on 2 medications, preoperative medicated IOP of 18-30 mmHg, and IOP following medication washout of 22-38 mmHg. Two trabecular micro-bypass stents were implanted as a standalone procedure, and travoprost was started on postoperative day 1. Evaluations included IOP, best-corrected visual acuity, medication use, fundus and slit-lamp examinations, visual field, cup:disc ratio, central corneal thickness, and ocular complications. Data through 18 months were summarized previously. Thirty-seven of the original 39 subjects have been followed for 3 years postoperatively; follow-up is continuing for 5 years. RESULTS: At 3 years postoperative, 97% of eyes had achieved an IOP reduction of ≥20% from baseline with a reduction of 1 medication. Eighty-six percent of eyes had IOP of ≤18 mmHg with a reduction of 1 medication. Mean medicated IOP decreased to 14.0±2.6 mmHg on 1 medication versus 22.4±2.3 mmHg on 2 medications preoperatively. The mean unmedicated IOP decreased to 17.7±1.7 mmHg at 37 months from 25.3±1.9 mmHg preoperatively. Long-term postoperative adverse events included cataract surgery in 3 eyes due to cataract progression, and trabeculectomy in 1 eye due to uncontrolled IOP of 23 mmHg. No intraoperative or device-related adverse events occurred. CONCLUSION: Significant and sustained reduction in IOP and medications with a favorable safety profile was shown through 3 years after implantation of 2 trabecular micro-bypass stents combined with postoperative travoprost in phakic OAG eyes uncontrolled on 2 preoperative medications. These findings demonstrate the long-term performance and safety of trabecular bypass stents in combination with topical prostaglandin for OAG patients.

Modern laser in situ keratomileusis outcomes.

UNLABELLED: Laser in situ keratomileusis (LASIK) articles published between 2008 and 2015 that contain clinical outcomes data were reviewed and graded for quality, impression, and potential bias. All 97 relevant articles (representing 67 893 eyes) provided a positive or neutral impression of LASIK. Industry bias was not evident. The aggregate loss of 2 or more lines of corrected distance visual acuity was 0.61% (359/58 653). The overall percentage of eyes with uncorrected distance visual acuity better than 20/40 was 99.5% (59 503/59 825). The spherical equivalent refraction was within ±1.0 diopter (D) of the target refraction in 98.6% (59 476/60 329) of eyes, with 90.9% (59 954/65 974) within ±0.5 D. In studies reporting patient satisfaction, 1.2% (129/9726) of patients were dissatisfied with LASIK. Aggregate outcomes appear better than those reported in summaries of the safety and effectiveness of earlier laser refractive surgery systems approved by the U.S. Food and Drug Administration. Modern results support the safety, efficacy, and patient satisfaction of the procedure. FINANCIAL DISCLOSURE: Proprietary or commercial disclosures are listed after the references.