SETTING: Departments of Ophthalmology, University of Malaya, Kuala Lumpur, Malaysia, and Tan Tock Seng Hospital, Singapore.
METHODS: In a randomized, double-blind study performed at two centers, 51 patients received an HSM PMMA lens and 48, an unmodified PMMA IOL. Cell and pigment deposits were evaluated by slitlamp at 1 to 6 days, 2 to 3 weeks, and 3 to 6 months postoperatively.
RESULTS: Significantly more eyes with unmodified IOLs had inflammatory cell deposits than those with HSM IOLs at 3 to 6 months (P < .001) and 12 to 14 months (P = .018) postoperatively. The HSM group also had significantly fewer cell deposits per patient at these two follow-ups. Significantly more eyes in the non-HSM group had pigment deposits 3 to 6 months after surgery (P = .049). One year postoperatively, about 85% of patients in both groups had a best corrected visual acuity of 0.5 or better.
CONCLUSION: Heparin surface modification significantly reduced the inflammatory response to PMMA IOLs in an Asian population for at least 12 to 14 months.
METHODS: Healthy soft CL wearers were invited to participate in this study. Visual acuity (VA) was measured using the Snellen chart, and subjective refraction was performed using cross-cylinder technique. Standard ocular assessments were conducted using a slit lamp biomicroscope and morphology of corneal endothelial cells (endothelial cell density, ECD, coefficient variation, COV, hexagonality, HEX and central corneal thickness, CCT) were evaluated using a non-contact specular microscope. Statistical analysis was conducted using ANOVA and data from the right eye only is included.
RESULTS: A total of 72 subjects (32 SiHy and 40 HCL wearers) and 24 non-CL wearers (control) participated in this study. The gender distribution for study subjects was 13 males and 59 females, with a mean age 22.15 ± 1.84 years old. The mean refraction was -1.86 ± 1.25DS. The duration of wearing CL ranged from 1 to 9 years. Subjects were later divided into 2 groups following duration of CL wear: Group 1 (<5 years) and Group 2 (≥5 years) for analysis purposes. Statistical analysis showed significant alterations in ECD, COV and HEX of CL wearers (p
METHODS: We trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of 'patient use'. The phases of 'patient use' are divided into: 1) inspecting, 2) preparing, and 3) applying medical device.
RESULTS: As for the question on the beginning point of 'patient use,' 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups.
CONCLUSION: From training courses using virtual cases, we found that there was no consensus on 'patient use' point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.
DESIGN: Prospective interventional case series.
METHODS: Patients with bilateral significant cataracts and pre-existing corneal astigmatism underwent cataract surgery and implantation with the AcrySof™ IQ Vivity™ toric IOL. Dominant eyes were targeted at emmetropia and non-dominant eyes at -0.50D. Primary endpoints were binocular uncorrected distance (UDVA), intermediate (UIVA at 66 cm) and near (UNVA at 40 cm) acuities at 3 months. Secondary outcomes were corrected distance (CDVA), distance corrected intermediate (DCIVA) and distance corrected near (DCNVA), refractive predictability, rotational stability, binocular defocus curve, contrast sensitivity, Questionnaire for Visual Disturbances (QUVID) and Visual Function Index (VF-14) questionnaire scores. All visual acuities were converted to logarithm of minimum angle of resolution (logMAR) for analysis.
RESULTS: 30 patients underwent uneventful phacoemulsification. The mean binocular UDVA, UIVA and UNVA were 0.06 ± 0.12, 0.11 ± 0.10 and 0.26 ± 0.10 respectively. The mean refractive spherical equivalent (MRSE) for dominant and non-dominant eyes were - 0.07D ± 0.27 and - 0.12D ± 0.54 respectively. 92.4% of dominant eyes and 84.6% of non-dominant eyes within 0.50D of target. The mean IOL rotation was 3.85° ± 5.09 with 86.7% of eyes with less than 5° of rotation. 26.7%, 20% and 36.7% of patients reported starbursts, haloes and glare respectively. The mean VF-14 score was 91.77.
CONCLUSION: Bilateral implantation of the AcrySof™ IQ Vivity™ Toric IOL resulted in very good unaided visual acuities for far and intermediate distance with functional near vision. Dysphotopsias were reported but despite this, a high level of visual function was achieved.
METHODS: Data was collected from the web-based MOH CSR. All consecutive cataract surgery patients from 1st June 2008 to 31st December 2014 were identified. Exclusion criteria were traumatic cataract or previous ocular surgery. Demographic data, ocular co-morbidities, intraoperative details and postoperative visual acuity (VA) at final ophthalmological follow-up were noted. All eyes were taken for analysis. Subjects with POE were compared against subjects with no POE for risk factor assessment using multiple logistic regressions.
RESULTS: A total of 163 503 subjects were screened. The incidence of POE was 0.08% (131/163 503). Demographic POE risk factors included male gender (OR: 2.121, 95%CI: 1.464-3.015) and renal disease (OR: 2.867, 95%CI: 1.503-5.467). POE risk increased with secondary causes of cataract (OR: 3.562, 95%CI: 1.740-7.288), uveitis (OR: 11.663, 95%CI: 4.292-31.693) and diabetic retinopathy (OR: 1.720, 95%CI: 1.078-2.744). Intraoperative factors reducing POE were shorter surgical time (OR: 2.114, 95%CI: 1.473-3.032), topical or intracameral anaesthesia (OR: 1.823, 95%CI: 1.278-2.602), posterior chamber intraocular lens (PCIOL; OR: 4.992, 95%CI: 2.689-9.266) and foldable IOL (OR: 2.276, 95%CI: 1.498-3.457). POE risk increased with posterior capsule rupture (OR: 3.773, 95%CI: 1.915-7.432) and vitreous loss (OR: 3.907, 95%CI: 1.720-8.873). Postoperative VA of 6/12 or better was achieved in 15.27% (20/131) subjects with POE.
CONCLUSION: This study concurs with other studies regarding POE risk factors. Further strengthening of MOH CSR data collection process will enable deeper analysis and optimization of POE treatment.