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.

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.

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.

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.