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.

Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses.

PURPOSE: To determine and compare the incidence of posterior capsule opacification (PCO) and neodymium:YAG (Nd:YAG) laser capsulotomy after implantation of 3 intraocular lens types (IOLs). SETTING: Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: This retrospective chart review comprised eyes having uneventful phacoemulsification and implantation of 1 of 3 AcrySof IOLs: ReSTOR SN60D3 (multifocal spherical group), Natural SN60AT (monofocal spherical group), or IQ SN60WF (monofocal aspheric group). Eyes were matched by age, sex, and follow-up. The PCO rate, Nd:YAG capsulotomy rate, time from surgery to PCO diagnosis, and time from surgery to Nd:YAG capsulotomy were assessed. RESULTS: Charts of 225 eyes (75 in each group) with a mean follow-up of 15.9 months +/- 6.5 (SD) were evaluated. The PCO rate was 42.7% in the multifocal spherical group, 28.0% in the monofocal spherical group, and 14.7% in the monofocal aspheric group. The Nd:YAG capsulotomy rate was 25.3%, 17.3%, and 4.0%, respectively. The difference in the Nd:YAG rate was statistically significantly higher in the multifocal and monofocal spherical groups than in the monofocal aspheric group (P<.001 and P<.008, respectively) but was not significantly different between the 2 spherical IOL groups (P = .232). The time from surgery to PCO documentation was not significantly different between the 3 groups. CONCLUSIONS: Intraocular lens configuration may have contributed to the difference in the PCO rate between the 2 spherical IOLs and the aspheric IOL. Based on the Nd:YAG rate as an indicator for visual significance, PCO may be less visually significant in eyes with the aspheric IOL than in eyes with 1 of the spherical IOLs.

LASIK world literature review: quality of life and patient satisfaction.

PURPOSE: To analyze the patient reported outcome of satisfaction after LASIK surgery. DESIGN: Systematic review. PARTICIPANTS: Patient data from previously reported studies. METHODS: A literature search conducted for the years 1988 to 2008 that included pertinent LASIK surgery information from the review of 2915 retrieved citations. All abstracts from these citations were reviewed and 1581 were deemed to be relevant for review. Complete copies of each of these relevant (1581) articles were obtained, and after thorough analysis each was rated based on the strength of the study design and weight of evidence. A level I rating was assigned to properly conducted, well-designed, randomized clinical trials; a level II rating to well-designed cohort and case-control studies; and a level III rating to case series, case reports, and poorly designed prospective and retrospective studies. Level I and II rated, peer-reviewed articles were entered into a database, and level III articles were eliminated. A total of 309 articles were incorporated into this database, representing level I and level II well-controlled studies of primary LASIK surgery. MAIN OUTCOME MEASURES: Patients' satisfaction rates and factors associated with dissatisfaction. RESULTS: Nineteen of the 309 database articles (6.1%) reported on both patient quality of life and satisfaction and together encompassed a total of 2198 subjects. The procedures from these 19 articles took place between 1995 and 2003. The overall patient satisfaction rate after primary LASIK surgery was 95.4% (2097 of 2198 subjects; range of patient satisfaction for the 19 articles was 87.2%-100%). The patient satisfaction rate after myopic LASIK was 95.3% (1811 of 1901 patients), and after hyperopic LASIK was 96.3% (286 of 297 subjects). CONCLUSIONS: Based on this review, worldwide, an average 95.4% of patients were satisfied with their outcome after LASIK surgery. With 16.3 million procedures performed worldwide, and more than a decade of clinical studies and technological innovation, LASIK surgery should be considered among the most successful elective procedures. LASIK surgery compares more favorably with other elective surgical procedures in terms of generally higher satisfaction rates.