Clinical Outcomes After Bilateral Implantation of a Diffractive Trifocal Intraocular Lens: A Worldwide Pooled Analysis of Prospective Clinical Investigations.

Purpose: To investigate visual and safety outcomes of AcrySof® IQ PanOptix® (model TFNT00), a trifocal, presbyopia-correcting intraocular lens (IOL), in patients of different ethnicities across multiple countries, based on a pooled analysis of six prospective multicenter studies. Patients and Methods: This pooled analysis included adult patients from six prospective clinical studies performed across 56 centers worldwide. After cataract removal by phacoemulsification, all patients were implanted with TFNT00; follow-up duration varied from 3 to 12 months according to the studies' design. Binocular defocus curve; absolute manifest refraction spherical equivalent (MRSE); and binocular photopic uncorrected and corrected visual acuities at distance (UCDVA, BCDVA; 4-5 m), intermediate (UCIVA, DCIVA; 60-66 cm), and near (UCNVA, DCNVA; 40 cm) were measured. Results: The study included 557 patients, 547 of whom were implanted bilaterally with the TFNT00 IOL (n = 1094 eyes). Binocular visual data at 1 month and 3-6 months after implantation were available for up to 546 and 542 bilaterally implanted patients, respectively. A continuous range of 0.1 logarithm of the minimum angle of resolution (logMAR) or better vision from distance (0.00 diopter [D], 4-5 m) to near (-3.00 D; optically equivalent to 33 cm) was observed 3-6 months after TFNT00 implantation. At 3-6 months, 88.2% of first eyes achieved an MRSE ≤0.50 D and 88.7% of second eyes achieved an MRSE ≤0.50 D. Overall, 99.3%, 92.3%, and 94.6% of patients bilaterally implanted with TFNT00 achieved binocular photopic BCDVA, DCIVA, and DCNVA of 0.14 logMAR or better, respectively. Ocular adverse device effects and secondary surgical interventions (SSIs) were infrequent. Conclusion: This global pooled analysis showed that TFNT00 provided a continuous range of 0.1 logMAR (~20/25 Snellen) or better vision from distance to 33 cm, with a low incidence of ocular adverse device effects and SSIs.

Systane iLux Thermal Pulsation System in the Treatment of Meibomian Gland Dysfunction: A Post-Hoc Analysis of a 12-Month, Randomized, Multicenter Study.

Purpose: This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment. Methods: This is a post-hoc analysis of a previous prospective, assessor-masked, parallel-group, multicenter study (NCT03956225) that compared the effectiveness and safety of iLux with LipiFlow in subjects with MGD. The original study included subjects with meibomian gland score (MGS) ≤12 in lower eyelids, Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score >16, and non-invasive tear break-up time (NITBUT) <10 seconds. Subjects were randomized (1:1) to receive a single bilateral treatment of iLux or LipiFlow. In this post-hoc analysis, mean changes in MGS, NITBUT (first break-up; seconds), IDEEL-SB module score, and corneal staining, from baseline to 12 months were analyzed post-single treatment with iLux. Results: Data from 119 patients (n=238 eyes) treated with iLux were analyzed. The mean±SD age of the subjects was 58.4±13.4 years, with majority being female (79.0%). MGS (mean±SD) for both eyes improved significantly from baseline to 12 months (OD [baseline: 6.9±3.69; month 12: 22.8±11.31; change: 15.9±11.57, p<0.0001]; OS [baseline: 6.4±3.66; month 12: 23.0±11.33; change: 16.7±11.40, p<0.0001]). Similarly, significant improvements were observed in NITBUT (OD [baseline: 5.2±1.97; month 12: 7.0±3.68; change: 1.9±3.69, p<0.0001]; OS [baseline: 5.6±1.96; month 12: 7.9±4.58; change: 2.3±4.59, p<0.0001]) and IDEEL-SB score (p<0.0001). Corneal staining reduced significantly from baseline to 12 months (OD [baseline: 2.1±2.96; month 12: 0.7±1.56; change: -1.4±2.65, p<0.0001]; OS [baseline: 2.1±2.94; month 12: 0.7±1.44; change: -1.4±2.75, p<0.0001]). Improvements in MGS, NITBUT, IDEEL-SB module score, and corneal staining were seen as early as week 2, and at months 1, 3, 6, and 9 (all p<0.001). Conclusion: A single treatment with iLux significantly improved clinical parameters of MGS, NITBUT, and corneal staining, and patient-reported symptom assessment with IDEEL-SB in patients with MGD over 12 months.

Comparison of Two Thermal Pulsation Systems in the Treatment of Meibomian Gland Dysfunction: A Randomized, Multicenter Study.

SIGNIFICANCE: Given the significance of meibomian gland dysfunction subjects in evaporative dry eye, its chronic and progressive nature, limited promising treatment options, and novel treatment techniques are important. This randomized clinical study evaluated the noninferiority of SYSTANE iLux with LipiFlow in meibomian gland dysfunction treatment at 12 months. PURPOSE: This study aimed to demonstrate noninferiority of SYSTANE iLux compared with LipiFlow at 12 months after single treatment in meibomian gland dysfunction subjects with evaporative dry eye. METHODS: In this prospective, randomized, multicenter, assessor-masked, parallel-group trial, subjects (N = 236; aged ≥18 years) with meibomian gland score (MGS) of ≤12 in lower eyelids, noninvasive tear breakup time (NITBUT; first breakup) of <10 seconds, and Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score of >16 were randomized (1:1) to receive SYSTANE iLux (n = 119) or LipiFlow (n = 117). Subjects attended a total of eight visits, including screening, treatment, and follow-up visits at 2 weeks and at 1, 3, 6, 9, and 12 months/exit, to evaluate change from baseline in MGS, NITBUT, IDEEL-SB module score, and safety outcomes. RESULTS: A total of 227 subjects completed the study (mean ± standard deviation age, 57.3 ± 13.8 years). At 12 months, least squares mean change from baseline in MGS was similar between iLux and LipiFlow (17.4 ± 1.97 vs. 17.8 ± 1.98). Noninferiority of SYSTANE iLux compared with LipiFlow in change from baseline in MGS (95% lower confidence limit of least squares mean difference, >-5), NITBUT (>-2.5 seconds), and IDEEL-SB score (95% upper confidence limit, <12) was achieved at all post-treatment visits. No other serious ocular or device-related adverse events were reported. CONCLUSIONS: The treatment outcomes with SYSTANE iLux were noninferior to LipiFlow during the 12-month follow-up in subjects with dry eye-associated meibomian gland dysfunction.

Rotational Stability of the Clareon Monofocal Aspheric Hydrophobic Acrylic Intraocular Lens 6 Months After Implantation.

PURPOSE: To determine the rotational stability of the Clareon® aspheric, monofocal, intraocular lens (IOL) up to 6 months after implantation. METHODS: This prospective, single-arm clinical study evaluated rotational stability of the Clareon IOL in a subset of subjects (n=141, 6 sites) that participated in an investigational device exemption trial for the Clareon IOL. The Clareon model (SY60CL) used in this subset was a non-toric IOL with toric axis markings to measure IOL rotation. All subjects (adults aged ≥22 years who required cataract extraction by phacoemulsification) received the Clareon IOL unilaterally. The position of the toric markings was captured using dilated retro-illumination slit-lamp photography and ocular anatomical landmarks. Post-operative rotational stability was assessed by an independent reading center. IOL rotation was defined as the difference between IOL axis of orientation on the day of surgery (≤1 hour after surgery) and each post-operative visit. Post-operative IOL-based rotational stability was evaluated at day 0 (day of surgery), day 1, week 1, month 1, and month 6 post-operatively. RESULTS: Compared with day 0, mean absolute IOL rotation was 1.85° on day 1 (n=127) and 2.27° at month 6 (n=124). Absolute IOL rotation ≤5° was observed in 95.3% of subjects on day 1 and 92.7% of subjects at month 6, compared with day 0. Between consecutive months 1 and 6 visits, mean absolute rotation was <1°; 100% of subjects had <10° rotation and 98.4% had ≤5°. The range of rotation on day 1 was 0° to 40.0° because of a subject with ocular trauma; when the trauma-outlier was removed, the mean absolute IOL rotation was 1.6° on day 1 (n=126) and 2.0° at month 6 (n=123). CONCLUSION: These results support the high rotational stability of the Clareon monofocal IOL and serve as reference of the rotational stability of Clareon toric IOLs.

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens.

PURPOSE: To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon). DESIGN: Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial. PARTICIPANTS: Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision. METHODS: Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria. MAIN OUTCOME MEASURES: The coprimary effectiveness outcomes were mean photopic monocular best-corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances. RESULTS: Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n = 129) or SN60AT (n = 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6. CONCLUSIONS: The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (+0.5 D to -2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery.

Clinical outcomes after aphakic versus aphakic/pseudophakic intraoperative aberrometry in cataract surgery with toric IOL implantation.

PURPOSE: To determine if there was a clinically significant difference in clinical outcomes after toric IOL implantation based on intraoperative aberrometry (IA), where eyes were measured either in the aphakic state only or both the aphakic and pseudophakic states. METHODS: A prospective, randomized, contralateral eye study was performed at one site in Poughkeepsie, NY, USA. Subjects included patients presenting for uncomplicated bilateral cataract surgery eligible for toric lens implantation with regular corneal astigmatism in both eyes whose toric IOL implantation was based on IA. One eye was measured when aphakic and the other when both aphakic and pseudophakic. The primary outcome measure was the magnitude of residual refractive astigmatism. Secondary measures included the percentage of eyes with 0.50D or less of residual refractive astigmatism, the spherical equivalent refraction and the time for IA measurement. RESULTS: Mean residual refractive astigmatism was not statistically significantly different between groups (0.32D ± 0.46D IA_1 vs. 0.23D ± 0.35D IA_2, p = 0.25), nor was the percentage of eyes with a residual refractive cylinder of 0.50D or less (94% in both groups, p = 1.0). The average time to measure the pseudophakic eye was 3 min, 46 s. Aphakic IA measurements appeared to produce better spherical equivalent refractive results relative to preoperative calculations. CONCLUSION: Pseudophakic IA measurements took nearly 4 min per case. Residual refractive astigmatism was not appreciably lower when pseudophakic IA measurements were made after aphakic IA measurements, which suggests aphakic IA measurements alone provide good clinical results with toric IOLs.

Bilateral implantation of +3.0 D multifocal toric intraocular lenses: results of a US Food and Drug Administration clinical trial.

PURPOSE: The purpose of this study was to evaluate the clinical outcomes of apodized diffractive +3.0 D multifocal toric intraocular lens (IOL) implantations in subjects with preoperative corneal astigmatism. PATIENTS AND METHODS: This was a prospective cohort study conducted at 21 US sites. The study population consisted of 574 subjects, aged ≥21 years, with preoperative astigmatism 0.75-2.82 D, and potential postoperative visual acuity (VA) ≥0.2 logMAR, undergoing bilateral cataract removal by phacoemulsification. The intervention was bilateral implantation of aspheric apodized diffractive +3.0 D multifocal toric or spherical multifocal nontoric IOLs. The main outcome measures were monocular uncorrected near and distance VA and safety at 12 months. RESULTS: A total of 373/386 and 182/188 subjects implanted with multifocal toric and nontoric IOLs, respectively, completed 12-month follow-up after the second implantation. Toric IOLs were nonin-ferior in monocular uncorrected distance (4 m) and near (40 cm) VA but had >1 line better binocular uncorrected intermediate VA (50, 60, and 70 cm) than nontoric IOLs. Toric IOLs reduced cylinder to within 0.50 D and 1.0 D of target in 278 (74.5%) and 351 (94.1%) subjects, respectively. Mean ± standard deviation (SD) differences between intended and achieved axis orientation in the first and second implanted eyes were 5.0°±6.1° and 4.7°±4.0°, respectively. Mean ± SD 12-month IOL rotations in the first and second implanted eyes were 2.7°±5.8° and 2.2°±2.7°, respectively. No subject receiving toric IOLs required secondary surgical intervention due to optical lens properties. CONCLUSION: Multifocal toric IOLs were noninferior to multifocal nontoric IOLs in uncorrected distance and near VAs in subjects with preexisting corneal astigmatism and effectively corrected astigmatism of 0.75-2.82 D.

Nepafenac 0.3% after Cataract Surgery in Patients with Diabetic Retinopathy: Results of 2 Randomized Phase 3 Studies.

PURPOSE: To demonstrate the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes. DESIGN: Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. PARTICIPANTS: Total, 615 patients in study 1 and 605 patients in study 2. METHODS: Patients were randomized (1:1) to topical nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. MAIN OUTCOME MEASURES: Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months. RESULTS: A significantly lower percentage of patients demonstrated ME within 90 days after surgery with nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P < 0.001; study 2: 5.9% vs. 14.3%; P = 0.001; pooled: 4.1% vs. 15.9%; P < 0.001). The percentage of patients achieving a ≥15-letter improvement from baseline through day 14 maintained through day 90 with nepafenac 0.3% versus vehicle was 61.7% versus 43.0% (P < 0.001) in study 1, 48.8% versus 50.5% (P = 0.671) in study 2, and 55.4% versus 46.7% (P = 0.003) in the pooled analysis. A greater percentage of patients treated with nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [P = 0.009] and 65.4% vs. 65.9% [P = 0.888]) and through day 60 (76.2% vs. 64.7% [P = 0.002] and 68.9% vs. 62.1% [P = 0.092]). No unanticipated adverse events were observed. CONCLUSIONS: These studies demonstrated the clinical benefits of nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.

Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery.

PURPOSE: To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. SETTING: Twenty-four ophthalmic clinical practices in the United States. DESIGN: Prospective randomized parallel-arm controlled multicenter subject-masked study. METHODS: Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. RESULTS: Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05). CONCLUSIONS: In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress.

Once-daily nepafenac ophthalmic suspension 0.3% to prevent and treat ocular inflammation and pain after cataract surgery: phase 3 study.

PURPOSE: To evaluate once-daily nepafenac 0.3% to prevent and treat ocular pain and inflammation after cataract surgery. SETTING: Sixty-five centers in the United States and Europe. DESIGN: Randomized double-masked vehicle- and active-controlled phase 3 study. METHODS: Patients received nepafenac 0.3% once daily, nepafenac 0.1% 3 times daily, or their respective vehicles from day -1 to day 14 after cataract extraction. An additional drop of study drug was administered 30 to 120 minutes preoperatively. The primary endpoint was the percentage of patients with a cure for inflammation (score of 0 for both aqueous cells and flare) at day 14. RESULTS: Of randomized patients, 817 received nepafenac 0.3%, 819 received nepafenac 0.1%, and 200 and 206 received the respective vehicles. Significantly more nepafenac 0.3% patients had no inflammation (68.4% versus 34.0%) and were pain free (91.0% versus 49.7%) at day 14 than vehicle patients (both P<.0001). Nepafenac 0.3% was noninferior to nepafenac 0.1% for inflammation (95% confidence interval [CI], -5.73% to 3.17%) and pain-free rates (95% CI, -3.08% to 2.70%). At all postoperative visits, fewer treatment failures (P≤.0012) and more clinical successes (P ≤ .0264) were observed with nepafenac 0.3% versus vehicle. Nepafenac 0.3% was well tolerated and had a safety profile comparable to that of nepafenac 0.1%. CONCLUSIONS: Once-daily nepafenac 0.3% was noninferior to nepafenac 0.1% 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery. The safety of nepafenac 0.3% was comparable to that of nepafenac 0.1%, with the added convenience of once-daily dosing. FINANCIAL DISCLOSURE: Drs. Modi, Lehmann, Walters, Fong, Christie, Roel, Nethery, and Reiser have been paid consultants to Alcon Research, Ltd. Ms. Sager is an employee of Alcon Research, Ltd. Drs. Tsorbatzoglou, Philipson, and Traverso have no financial or proprietary interest in any material or method mentioned.

Safety, efficacy, and intraoperative characteristics of DisCoVisc and Healon ophthalmic viscosurgical devices for cataract surgery.

PURPOSE: To evaluate the safety and efficacy of DisCoVisc ophthalmic viscosurgical device (OVD, Alcon Laboratories, Inc) with respect to a comparator, Healon OVD (Advanced Medical Optics, Inc). PATIENTS AND METHODS: In this prospective study, patients with cataracts were randomized to an OVD, and then received phacoemulsification and injection of an intraocular lens. After each surgery, unmasked investigators completed subjective questionnaires about OVD characteristics during each stage of the procedure. Masked technicians evaluated objective safety parameters of intraocular pressure (IOP) and endothelial cell density, with 90 days of follow-up. RESULTS: The DisCoVisc OVD group (128 eyes) and the Healon OVD group (121 eyes) had statistically similar outcomes for IOP and for endothelial cell loss. Subjectively assessed viscosity was statistically different (P < 0.0001), with Healon OVD most often rated "cohesive" and DisCoVisc OVD most often rated "both dispersive and cohesive". Workspace maintenance differed between groups (P < 0.0001), with workspace most frequently rated "full chamber maintained" when using DisCoVisc OVD and most frequently rated "workspace maintained" when using Healon OVD. "Flat" or "shallow" workspace ratings occurred only in the Healon OVD group. CONCLUSION: DisCoVisc OVD had both cohesive and dispersive properties, and was safe and effective for every stage of cataract surgery.

Contraceptive use among low-income urban married women in India.

INTRODUCTION: The reports of a rise in contraceptive practices have not been matched by a similar decrease in population, so there is a need to look into the causes of this discrepancy. AIM: To obtain information from low-income urban married women regarding their contraceptive knowledge, practices, and utilization of the services. MAIN OUTCOME MEASURE: Percentage of low-income urban married women using contraception, different types of contraception used, influence of education on choice of contraception. METHODS: All nonpregnant married women between the ages of 18 and 45 years, belonging to low-income groups were selected for study. Statistical analysis was done using EPI Info ver-5.0. Chi square test was used to test the significance of data. RESULTS: Contraceptive use among these women was 52%; the most common method was tubal ligation. Educated women used spacing methods more often than uneducated women. Women had adequate awareness regarding type of contraceptives available but had no idea about the timing of starting contraception after delivery and about emergency contraception. CONCLUSION: The low-income urban population is aware of the importance of limiting the family size and has family planning facilities yet has less contraceptive usage because of low level of education, increased rate of discontinuation, and lack of proper knowledge of the use of contraception.

Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study.

PURPOSE: To evaluate functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses (IOLs) with a +3.0 or +4.0 diopter (D) addition (add) power. SETTING: Twelve study centers in the United States. METHODS: This randomized patient-masked parallel-group 6-month follow-up study comprised patients having bilateral cataract extraction with implantation of an AcrySof IQ ReSTOR SN6AD3 IOL with a +4.0 D add power (+4.0 D group) or an AcrySof IQ ReSTOR SN6AD1 IOL with a +3.0 D add power (+3.0 D group) (both IOLs, Alcon, Inc.). Visual acuity, defocus testing, patient-reported outcomes, and safety measures were assessed. RESULTS: Of the 279 patients, 141 were in the +3.0 D group and 138 were in the +4.0 D group. Binocular distance-corrected intermediate visual acuity was statistically significantly better in the +3.0 D group than in the +4.0 D group (P<.0001); there was no difference in binocular near or distance visual acuity. There were no statistically significant differences in visual disturbances between the 2 groups. Patients in both groups reported excellent overall spectacle independence, near visual function, and satisfaction with the IOLs. CONCLUSIONS: Intermediate vision at a mean reading distance of approximately 40 cm was better with the aspheric IOL with a +3.0 D add than with the aspheric IOL with a +4.0 D add, as shown by the near peak in the mean binocular defocus curve; near and distance acuity were similar between the 2 IOLs. Patients reported excellent overall quality of vision, spectacle independence, and satisfaction.

Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular inflammation associated with cataract surgery.

PURPOSE: To determine whether nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation. SETTING: Twenty-one ophthalmology clinics in the United States. METHODS: A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score = 0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores. RESULTS: The mean age of the 476 patients (243 nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the nepafenac group and 40 (17.2%) in the vehicle group were cured (P<.0001). A higher percentage of patients in the nepafenac group was pain free at all visits (P<.0001). Throughout the study, most nepafenac-treated patients were pain free (83.1% to 93.0%) compared with less than half the vehicle-treated patients (41.6% to 46.4%). The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P<.0001). No treatment-related ocular adverse events occurred in either group. CONCLUSION: Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.