Simultaneous bilateral cataract surgery: economic analysis; Helsinki Simultaneous Bilateral Cataract Surgery Study Report 2.

PURPOSE: To present an economic-analysis comparison of simultaneous and sequential bilateral cataract surgery. SETTING: Helsinki University Eye Hospital, Helsinki, Finland. DESIGN: Economic analysis. METHODS: Effects were estimated from data in a study in which patients were randomized to have bilateral cataract surgery on the same day (study group) or sequentially (control group). The main clinical outcomes were corrected distance visual acuity, refraction, complications, Visual Function Index-7 (VF-7) scores, and patient-rated satisfaction with vision. Health-care costs of surgeries and preoperative and postoperative visits were estimated, including the cost of staff, equipment, material, floor space, overhead, and complications. The data were obtained from staff measurements, questionnaires, internal hospital records, and accountancy. Non-health-care costs of travel, home care, and time were estimated based on questionnaires from a random subset of patients. The main economic outcome measures were cost per VF-7 score unit change and cost per patient in simultaneous versus sequential surgery. RESULTS: The study comprised 520 patients (241 patients included non-health-care and time cost analyses). Surgical outcomes and patient satisfaction were similar in both groups. Simultaneous cataract surgery saved 449 Euros (€) per patient in health-care costs and €739 when travel and paid home-care costs were included. The savings added up to €849 per patient when the cost of lost working time was included. CONCLUSION: Compared with sequential bilateral cataract surgery, simultaneous bilateral cataract surgery provided comparable clinical outcomes with substantial savings in health-care and non-health-care-related costs. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Simultaneous bilateral versus sequential bilateral cataract surgery: Helsinki Simultaneous Bilateral Cataract Surgery Study Report 1.

PURPOSE: To evaluate the refractive outcomes, complication rates, and changes in patients' functional state and satisfaction with simultaneous compared with sequential bilateral cataract surgery. SETTING: Helsinki University Eye Hospital, Helsinki, Finland. DESIGN: Clinical trial. METHODS: Consecutive patients scheduled for bilateral cataract surgery were enrolled based on appropriate inclusion criteria and randomized to be operated on in 1 session (study group) or sequentially (control group) 4 to 6 weeks apart. RESULTS: Four hundred ninety-one (94.4%) of the 520 patients completed the study. Of the eyes, 493 (247 patients) had bilateral surgery in 1 session and 506 (257 patients) in separate sessions. In the study group, 240 patients (96.0%) were treated per protocol. In the control group, 250 patients (97.3%) were treated per protocol. The refraction was within ± 0.50 diopter (D) of the target in 67.2% of eyes in the study group and 69.2% of eyes in the control group and within ± 1.00 D in 91.0% and 90.3%, respectively (P = .92). The only complication that affected postoperative visual acuity was chronic cystoid macular edema, which occurred in 1 eye in the study group (0.2%) and in 2 eyes (0.4%) of 1 patient in the control group (P = .57). Ninety-five percent of patients in both groups reported being very satisfied with surgery. CONCLUSION: The refractive outcomes, rates of complications, and patient-rated satisfaction were similar whether bilateral cataract surgery was performed simultaneously or sequentially. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Traumatic cataract and other adverse events with the implantable contact lens.

PURPOSE: To evaluate the surgical outcome and adverse events associated with implantation of the implantable contact lens (ICL) for the correction of high myopia or high hyperopia. SETTING: Helsinki University Eye Hospital, Helsinki, Finland. METHODS: In this nonrandomized prospective clinical trial, the ICL V4 was implanted in 26 eyes of 13 patients with normal enrollment criteria (younger than 45 years, a clinically clear crystalline lens) (Group 1) and the V2, V3, or V4 were implanted in 38 eyes of 22 patients with heterogeneous criteria (older than 45 years or opacities in the crystalline lens) (Group 2). The main outcome measures were lens opacity classification system (LOCS II) assessment and transparency analysis of the lens. RESULTS: In Group 1, microdensitometric assessment showed no decrease in crystalline lens transparency and no statistically significant increase in crystalline lens density at any follow-up examination (P>.05). The incidence of anterior subcapsular (AS) opacities was 7.7%, and no eye developed clinically significant cataract during the mean follow-up of 13.2 months +/- 12.3 (SD). No myopic eye lost a line of best corrected visual acuity (BCVA); 50.0% of hyperopic eyes lost 1 line of BCVA. Sixty-eight percent of myopic eyes and 75.0% of hyperopic eyes were within +/-1.0 diopter of the predicted refraction. In Group 2, the incidence of AS opacities was 47.4% and 10 eyes (26.3%) developed clinically significant cataract during the mean follow-up of 30.9 +/- 18.0 months. The visual and refractive results were similar to those in Group 1 at 1 month, but due to progressive AS opacities in the crystalline lens, 23.4% of eyes lost BCVA lines during the follow-up. Intraoperative complications were few and insignificant. CONCLUSIONS: Implantation of the ICL for correction of high myopia or high hyperopia appears to be a safe procedure with good visual and refractive results immediately. There was no decrease in the transparency or increase in the density of the crystalline lens with the latest generation of the ICL device in the normal group, indicating enhanced safety. Progressive lens opacification in the heterogeneous group shows there are risk factors for cataract formation; ie, type V3 ICL, preexisting lens opacities, and older patient age. Anterior subcapsular opacities are most likely the result of trauma.

Quality of vision after AMO Array multifocal intraocular lens implantation.

PURPOSE: To evaluate safety and efficacy of Array SA40N multifocal intraocular lens (IOL) (AMO) implantation in cataract surgery. SETTING: Helsinki University Eye Hospital, Helsinki, Finland. METHODS: In this prospective randomized comparative trial, 80 patients scheduled for cataract surgery were selected based on preoperative counseling and randomized to have multifocal or monofocal IOL implantation. Fifty-three eyes of 35 patients received a multifocal IOL and 67 eyes of 40 patients, a monofocal IOL. The incidence of complications and visual outcome in the multifocal and monofocal IOL groups were compared. Quality of vision was measured by comparing the severity of visual symptoms (glare, halos, and cataract symptoms score), changes in functional impairment measured by a 7-item visual function test (VF-7), changes in global measures of vision (trouble and satisfaction with vision), and range of accommodation and contrast sensitivity. RESULTS: Intraoperative and postoperative complications and adverse events were few and required no further surgical intervention. Both distance and near visual acuities were significantly better in the multifocal group than in the monofocal group; the difference was most prominent in distance corrected near acuity (P<.001). Thirty-five eyes (67.3%) in the multifocal group and 10 eyes (14.9%) in the monofocal group achieved a distance corrected near acuity of J6 (20/40) or better; 30 eyes (56.6%) and 19 eyes (28.4%), respectively, achieved a best corrected distance acuity of 20/20 or better. Glare symptoms decreased postoperatively in both groups but were slightly more common in the multifocal group. In contrast, halos were significantly more common at 1 month in the multifocal group (P<.001). Contrast sensitivity values were slightly lower with multifocal IOLs at almost all spatial frequencies, but the difference was not significant. The change in the quality of life postoperatively, measured with the VF-7, was significant and identical in both groups. CONCLUSIONS: Pseudophakic eyes with multifocal IOLs had better distance and near acuity and range of accommodation than eyes with a monofocal IOL. Slightly lower contrast sensitivity and increased perception of halos by subjects with the multifocal IOL appear to be an acceptable compromise to enhanced near and distance vision.

Implantable contact lens for high myopia.

PURPOSE: To evaluate the efficacy, safety, and biocompatibility of a collagen polymer implantable contact lens (ICL) (Staar Collamer) as a posterior chamber phakic intraocular lens (IOL) to correct high myopia. SETTING: Departments of Ophthalmology, Helsinki University Central Hospital, Helsinki, and Tampere University Hospital, Tampere, Finland. METHODS: A Staar Collamer posterior chamber phakic IOL was implanted in 38 eyes of 22 patients with a mean age of 39 years (range 24 to 54 years). The mean preoperative myopia was -15.10 diopters (D) (range -7.75 to -29.00 D). Surgical implantation was performed through a 3.0 mm clear corneal sutureless incision using paraocular anesthesia. The patients were followed clinically up to 3 years. The mean follow-up was 13.6 months (range 6 to 24 months) for refractive data and 22.3 months (range 6 to 35 months) for complications. The possible inflammatory response to the ICL was measured using a laser flare meter in 12 eyes. RESULTS: Postoperatively, all eyes had a significant increase in uncorrected visual acuity, allowing all but 3 patients (5 eyes) to manage most activities without spectacles. The mean spherical equivalent refraction at the last examination was -2.00 D +/- 2.48 (SD) (range +0.13 to -13.00 D), within +/-1.00 D of the targeted refraction in 31 eyes (81.6%) and within +/-0.50 D in 27 eyes (71.1%). In eyes in which the preoperative myopia was less than -18.00 D (n = 28), the achieved refraction was within +/-1.00 D of the intended refraction in 27 eyes (96.4%) and within +/-0.50 D in 24 eyes (85.7%). The refraction remained stable with a statistically insignificant change (P >.05) at each interval during the follow-up. The best corrected visual acuity (BCVA) improved by 1 or more lines in 23 of 32 eyes (71.9%) at 1 year. Two eyes (6.3%) lost 1 line of BCVA. Laser flare photometry showed normal aqueous flare values (11.71 +/- 6.61 photon counts/ms) in the 12 eyes measured at least 6 months after ICL implantation. Pupillary block glaucoma requiring surgical intervention occurred in 3 patients (7.9%). One patient (2.6%) developed cataract 1.5 years after ICL implantation; both ICLs were removed, and the refractive errors were corrected by lensectomy and implantation of low-power posterior chamber IOLs. One patient (2.6%) showed progression of dry macular degeneration at 17 months. CONCLUSION: At 1 year, ICL implantation had good visual and refractive results with excellent biocompatibility. Long-term follow-up is required to confirm that significant complications do not occur in most patients over time.