Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial.

BACKGROUND: Cataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness. METHODS/DESIGN: Multicenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire. DISCUSSION: This study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS. TRIAL REGISTRATION: This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .

The effect of bacteriochlorophyll derivative WST-D and near infrared light on the molecular and fibrillar architecture of the corneal stroma.

A cross-linking technique involving application of Bacteriochlorophyll Derivative WST-11 mixed with dextran (WST-D) to the epithelium-debrided cornea and illumination with Near Infrared (NIR), has been identified as a promising therapy for stiffening pathologically weakened corneas. To investigate its effect on corneal collagen architecture, x-ray scattering and electron microscopy data were collected from paired WST-D/NIR treated and untreated rabbit corneas. The treated eye received 2.5 mg/mL WST-D and was illuminated by a NIR diode laser (755 nm, 10 mW/cm2). An increase in corneal thickness (caused by corneal oedema) occurred at 1-day post-treatment but resolved in the majority of cases within 4 days. The epithelium was fully healed after 6-8 days. X-ray scattering revealed no difference in average collagen interfibrillar spacing, fibril diameter, D-periodicity or intermolecular spacing between treated and untreated specimens. Similarly, electron microscopy images of the anterior and posterior stroma in healed WST-D/NIR corneas and untreated controls revealed no obvious differences in collagen organisation or fibril diameter. As the size and organisation of stromal collagen is closely associated with the optical properties of the cornea, the absence of any large-scale changes following treatment confirms the potential of WST-D/NIR therapy as a means of safely stiffening the cornea.

Evaluation of the Lenstar LS 900 non-contact biometer.

BACKGROUND/AIMS: Evaluation of the reproducibility of the Lenstar LS 900 non-contact biometer, and a comparison with the Visante anterior-segment optical coherence tomography (AS-OCT) and the IOLMaster. METHODS: Central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT), keratometry (K) values, corneal diameter (CD) and axial length (AL) were obtained in 38 healthy volunteers (76 eyes) to determine the reproducibility of the Lenstar. CCT, ACD, CD, K values and AL measurements measured with the Lenstar were compared with the AS-OCT and IOLMaster. Intraocular lens (IOL) power calculations were done to study the significance of the difference between AL measurements. RESULTS: The reproducibility of the Lenstar was better than 0.9% for CCT, ACD, LT, K values and AL measurements. Although all correlations were highly significant (p<0.001), all comparisons showed a significant difference, except for the comparison of CD measurements using the Lenstar and IOLMaster (p = 0.175). The differences in IOL power calculations for an AL of 20, 25 and 30 mm with a mean difference between Lenstar and IOLMaster AL measurements of 0.03 mm, were 0.13 D, 0.10 D and 0.08 D, respectively. CONCLUSION: The reproducibility of the Lenstar was excellent. Small but significant differences exist between the Lenstar, Visante OCT and the IOLMaster. Therefore, measurements of the Lenstar, AS-OCT and IOLMaster are not interchangeable. Despite the significant difference between AL measurements, there is no clinically significant difference in the IOL power calculation results.

Lifetime costs and effectiveness of ReSTOR compared with a monofocal IOL and Array-SA40 in the Netherlands.

PURPOSE: To estimate the lifetime cost consequences for society and the National Health Service (NHS) of bilateral monofocal (SI40NB) or multifocal (ReSTOR or Array-SA40) intraocular lense (IOL) implantation after cataract surgery. SETTING: Public hospital in the Netherlands. METHODS: A Markov model simulated three cohorts of patients followed 69 until 100 years of age, or death. Spectacle independence rates for each IOL were adjusted to the results of a randomized clinical trial that compared monofocal and multifocal Array-SA40 IOL implants, together with a prospective cohort of patients implanted with ReSTOR. Adjustment was performed using the propensity score method in a multivariate analysis. Resource consumption was estimated from a dedicated Dutch survey. Dutch unit costs were applied to spectacles, cataract surgery, IOLs, visits to ophthalmologists, optometrists, transport, and spectacle cleaning materials. Cost discounted at 4% and undiscounted economic results were calculated. RESULTS: Spectacle independence rates were 86.0% for ReSTOR, 8.7% for monofocal IOLs, and 8.5% for Array-SA40. Patients lived without needing spectacles for 12.9 years after ReSTOR, for 1.4 years after monofocal IOLs, and 1.3 years after Array-SA40. ReSTOR patients bought 6.4 fewer pairs of spectacles than monofocal patients. Lifetime discounted cost consequences for the society were ReSTOR euro3969, monofocal IOLs euro4123, and Array-SA40 euro5326. Corresponding costs for the NHS were euro2415, euro2555, and euro2556, respectively. CONCLUSIONS: ReSTOR IOLs provided higher levels of spectacle independence than monofocal SI40NB or multifocal Array-SA40 IOLs resulting in savings, compared to a monofocal, over the period modelled of euro315 for society and euro140 for the NHS.

Determinants of surgery related anxiety in cataract patients.

BACKGROUND/AIMS: Not much is known about the relative importance of different determinants of anxiety in cataract patients. This study analysed the predictive value of factors related to surgery induced anxiety. METHODS: In 128 cataract patients, recruited from two hospitals (Medical Centre Maastricht Annadal (MCMA) and Rotterdam Eye Hospital (REH)), state anxiety was assessed at four different time points using the State-Trait Anxiety Inventory (STAI). The following predictive factors of anxiety were measured: trait anxiety, outcome expectancies, doctor-patient relationship, coping strategy, social support, information supply, sociodemographic variables, and previous cataract surgery. Repeated measures ANOVA, t tests, multiple regression analysis, and correlations were used to analyse data. RESULTS: In general patients reported little anxiety. The level of anxiety (scale 1-4) was the highest before surgery, decreased immediately after surgery, and increased again after the postoperative visit. Patients with higher trait anxiety levels (r = 0.41; p<0.01), and women (r = 0.30; p<0.01) reported more anxiety. The REH patients showed lower anxiety scores than the MCMA patients. CONCLUSION: Women and patients with higher trait anxiety were more likely to experience higher levels of state anxiety. Positive outcome expectancies and social support may decrease anxiety.

Cost effectiveness of foldable multifocal intraocular lenses compared to foldable monofocal intraocular lenses for cataract surgery.

AIM: To analyse the cost effectiveness of foldable monofocal intraocular lenses (IOLs) compared to foldable multifocal IOLs in cataract surgery alongside a prospective, multicentre randomised clinical trial (RCT). METHODS: Patients underwent cataract surgery with bilateral monofocal (n = 97) or multifocal (n = 93) IOL implantation. Cost data and patient preferences, using the visual analogue scale (VAS), the time trade-off (TTO), and the standard gamble (SG) technique were obtained preoperatively and postoperatively by structured interviews. The incremental costs (multifocal minus monofocal), mean costs per patient, and differences in preferences were computed. RESULTS: Mean costs for glasses per patient in the monofocal group were 41.67 and in the multifocal group 149.58. The difference in costs between the multifocal and monofocal group was -92.09 and was statistically significant (p = 0.008). No significant differences were found in total costs or in effectiveness between the monofocal and multifocal IOL group. CONCLUSION: The cost effectiveness of multifocal IOLs is reduced to a cost minimisation analysis, because of the inability to demonstrate significant differences in effects. The use of multifocal IOLs in cataract surgery resulted in a significant reduction in costs for patient's postoperative spectacles.

[Refractive surgery: most commonly used techniques, results and complications]. / Refractiechirurgie: meest gebruikte technieken, resultaten en complicaties.

Refractive surgery is gaining enormous popularity. It is estimated that in 2001, refractive surgery was performed on 1 in 8000 persons in the Netherlands. Photorefractive keratectomy and laser in-situ keratomileusis are effective and predictable for the correction of myopia up to 10.0 D and hypermetropia up to +4.5 D. There is rarely any significant loss of best-corrected visual acuity postoperatively. For the correction of higher levels of myopia and hypermetropia, phakic intraocular lenses can be implanted in the anterior or posterior eye chamber, in other words in front of the natural lens. The magnification effect of these lenses often results in improved vision at higher levels of myopia. Good preoperative selection of refractive surgery candidates is essential and patients should be properly informed about the results, potential complications and adverse effects of refractive surgery techniques.

Quality of care from the perspective of the cataract patient: the reliability and validity of the QUOTE-cataract.

BACKGROUND/AIMS: To assess reliability and validity of the QUOTE-cataract, a questionnaire that measures the quality of care from the perspective of cataract patients. METHODS: The QUOTE-cataract was tested in a multicentre study among 540 cataract patients in three different hospitals. Reliability was represented by internal consistency (Cronbach's alpha), and repeatability (intraclass correlation coefficient (ICC)). Validity was evaluated qualitatively and by factor analyses. RESULTS: A strong internal consistency coefficient (0.89), and high repeatability (ICC = 0.76) demonstrated good reliability. Content validity was assured by involvement of patients in the development of the questionnaire. Factor analysis confirmed an underlying taxonomy of generic and disease specific items. CONCLUSION: The QUOTE-cataract has good reliability and provides a valid assessment of quality of care in cataract surgery.

A practical approach to and long-term results of fitting silicone contact lenses in aphakic children after congenital cataract.

PURPOSE: This prospective study investigated characteristics of fit and performance of silicone contact lenses under conditions of permanent wear in cases of aphakia after congenital cataract. METHODS: Seventeen aphakic children (8 eyes unilateral, 18 eyes bilateral) were fitted with silicone contact lenses on an empirical basis without the use of keratometry. The lenses were worn on a permanent basis, with a routine replacement every 3 months. The follow up was 6 years, with evaluation lens parameters, fitting characteristics, lens condition, replacement rate, wearing time, complications, and visual acuity. RESULTS: The back optical zone radius (BOZR) remained stable at 7.50 mm, up to the age of 1.5 years old. At the age of 4 years, almost all eyes needed a BOZR of 7.90 mm. Mean +/- SD contact lens power was +25.47 diopter (D) +/- 4.0 (range +32.00 D - +20.00 D) at 3 months of age, and +17.94 D +/- 3.8 (range +29.00 D - +15.00 D) at 3 years of age. This represents an average decrease of 0.23 D per month. The power decrease in unilateral cases was significantly lower (P < 0.01) than in bilateral aphakia. Snellen visual acuity at 4 years of age was 0.1 to 0.3 (20/200-20/60) in 15 eyes, 0.3 to 0.5 (20/60-20/40) in 10 eyes and greater than 0.5 (>20/40) in 1 eye. Lens usage over a total period of 90 wearing years was 5.6 lenses/eye/year, including the regular exchange every 3 months. No serious complications occurred. A positive correlation (r = 0.89) was found between age and deposit buildup. With the need for permanent wear reduced, therefore, 73% of the eyes were refitted with high-water content soft lenses or high gas-permeable (HGP) lenses, when the patients ranged in age from 4 to 6 years old. CONCLUSIONS: The procedure for fitting silicone lenses in aphakic children is feasible in an easy and logical way without keratometry. Permanent wear with a low complication rate is possible up to the age of 3. with a lens usage (including a 3-month regular exchange) of 5.6 lenses/eye/year. From the age of 3, deposit formation is the determining factor for refitting with high-water content soft or HGP lenses.