Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms.

INTRODUCTION: Myopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population. METHODS AND ANALYSIS: AIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8-12 years and myopia of -1 D to -6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months. ETHICS AND DISSEMINATION: AIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03865160.

[Detections of refractive risk factors for amblyopia with Plusoptix Autorefractor A09]. / Erkennung refraktiver Amblyopierisikofaktoren mittels Plusoptix Autorefractor A09.

BACKGROUND: Amblyopia is the most frequent cause for decreased vision in childhood. Important risk factors for amblyopia (ARF) are refractive errors. The aim of this study was to examine the reliability of the Plusoptix Autorefractor A09 (POA09) to detect refractive ARF. METHOD: This prospective non-blinded, one-armed study was conducted between February 2012 and September 2015. Children aged 6 months to 12 years were screened in kindergarten and schools for refractive errors. Thresholds for screening failure were hyperopia ≥ 3.5 diopters (D), myopia ≥ 3.0 D, anisometropia ≥ 1.5 D and astigmatism ≥ 1.5 D (axis 90° or 180°â€¯± 10°) or ≥ 1.0 D (≥ 10° axis deviation of 90° or 180°). Children who failed screening were advised to see an ophthalmologist for a comprehensive eye examination. After the visit, parents were asked for the results of the examination. A reference group of children who did not fail screening also received a comprehensive eye examination. Based on the number of children who failed screening, we calculated the proportion of correctly detected refractive errors. Based on the children of the reference group we calculated the proportion of correctly excluded refractive errors and the false negative rate. RESULTS: In this study 3170 children were screened, 715 children (22.3%) failed screening. For 460 of these (64.3%) follow-up was available and for 132 children information on refractive errors in cycloplegia was available. Most frequent refractive errors at screening were astigmatism (90.9%) and anisometropia (11.4%). Most frequent refractive errors in cycloplegia were astigmatism (56.8%) and hyperopia (18.9%). The proportion of correctly detected refractive errors in the screening was highest for astigmatism (60%) and anisometropia (53.3%), followed by hyperopia (33.3%) and myopia (25%). CONCLUSION: The reliability of POA09 to detect refractive ARF in children without cycloplegia was limited, highlighting the importance of a systematic amblyopia screening. A screening in cycloplegia can increase the proportion of correctly detected refractive ARF and should be studied.

Electrical neurostimulation in glaucoma with progressive vision loss.

BACKGROUND: The retrospective study provides real-world evidence for long-term clinical efficacy of electrical optic nerve stimulation (ONS) in glaucoma with progressive vision loss. METHODS: Seventy glaucoma patients (45 to 86 y) with progressive vision loss despite therapeutic reduction of intraocular pressure (IOP) underwent electrical ONS. Closed eyes were separately stimulated by bipolar rectangular pulses with stimulus intensities up to 1.2 mA sufficient to provoke phosphenes. Ten daily stimulation sessions within 2 weeks lasted about 80 min each. Right before ONS at baseline (PRE), vision loss was documented by static threshold perimetry and compared to the same assessment approximately 1 year afterwards (POST). Mean defect (MD) was defined as primary outcome parameter. Perimetries with a reliability factor (RF) of max. 20% were considered. RESULTS: Perimetry follow-up of 101 eyes in 70 patients fulfilled the criterion of a max. 20% RF. Follow-up was performed on average 362.2 days after ONS. MD significantly decreased from PRE 14.0 dB (median) to POST 13.4 dB (p < 0.01). 64 eyes in 49 patients showed constant or reduced MD as compared to baseline (PRE 13.4 dB vs. POST 11.2 dB). In 37 eyes of 30 patients, MD increased from PRE 14.9 dB to POST 15.6 dB. CONCLUSIONS: Innovative treatments that preserve visual function through mechanisms other than lowering IOP are required for glaucoma with progressive vision loss. The present long-term data document progression halt in more than 63% of affected eyes after ONS and, thus, extend existing evidence from clinical trials.

Rotation of a toric intraocular lens with and without capsular tension ring: data from a multicenter non-inferiority randomized clinical trial (RCT).

BACKGROUND: Evaluation of clinical outcome in cohorts with versus without simultaneous implantation of a capsular tension ring (CTR) and a toric lens (Tecnis Toric). Main parameter was rotation referring - in contrast to misalignment - to the IOL axis change from immediately after implantation to the final postoperative position. METHODS: Lens position was measured at baseline with the patient still in recumbent position, postoperative rotation was calculated by software. Postoperative evaluation included measurement three months after surgery or prior to an indicated revision surgery. Explorative re-evaluation of the underlying RCT's intent-to-treat population was performed for the entire sample and stratified for cohorts by 95% confidence intervals for binary endpoints' incidences (primary endpoint: absolute postoperative rotation ≤5 degrees; secondary endpoints: absolute deviation between achieved cylinder and target cylinder ≤0.5 dpt, postoperative corrected distance visual acuity (CDVA) ≥ 0.8). Data exploration was based on medians and quartiles. SETTING: Outpatient study sites. DESIGN: Re-evaluation based on data from a multicenter non-inferiority randomized clinical trial (RCT). RESULTS: Sub cohorts (without CTR 89, with CTR 90 patients) did not present clinically relevant differences in preoperative characteristics: revision surgery was performed in 7 cases (3 without and 4 with CTR). Primary endpoint incidences for the total sample, without and with CTR were 90%/89%/90%; cylinder endpoint incidences were 46%/45%/46% and CDVA endpoint incidences 90%/92%/88%. Median absolute rotations were 1.74°/1.79°/1.72°, median absolute cylinder deviations 0.55/0.52/0.55 dpt and median visual acuity 1.0/1.0/1.0. CONCLUSION: No clinically relevant differences between CTR subgroups were found; a satisfying three months rotational stability was achieved. TRIAL REGISTRATION: The trial was registered retrospectively in the trial registry DRKS, trial registration number DRKS00015316 , date of registration 27. August 2018.

Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension.

PRéCIS:: Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension. PURPOSE: The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension. METHODS: Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7±2.4 mm Hg overall before inclusion) were randomized at day 0 with no washout period to receive the preservative-free alternative T2347 (N=127) or remain on the preserved comparator (N=115) for 84 days. Intraocular pressure changes from day 0 were measured at 9:00 am (±1 hour) on day 42 and day 84, and noninferiority of T2347 to the preserved comparator was analyzed statistically at day 84. Safety parameters were also reported. RESULTS: The mean change in intraocular pressure from baseline to day 84 was -0.49±1.80 mm Hg for preservative-free T2347 and -0.49±2.25 mm Hg for the preserved comparator. These results met the noninferiority limits. Similar results were observed at day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P=0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P<0.001), and itching (P<0.01) on day 84. CONCLUSIONS: Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared with the preserved comparator and was well tolerated.

Efficacy and safety of dual-polymer hydroxypropyl guar- and hyaluronic acid-containing lubricant eyedrops for the management of dry-eye disease: a randomized double-masked clinical study.

BACKGROUND: An artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED. METHODS: In a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) <2 units. RESULTS: In total, 99 patients were randomized (HPG-HA, n= 50; SH, n= 49). At day 42, the least square (LS) mean ± SE change from baseline in TOSS was -1.16±0.24 and -0.92±0.23 in the HPG-HA and SH groups, respectively, and the treatment difference was -0.24±0.33 (95% CI -0.90 to 0.42). Noninfe-riority was demonstrated as the upper limit of the 95% CI was <2 units. LS mean change from baseline at day 42 for HPG-HA vs SH was -3.18 (P=0.4817) in IDEEL treatment-effectiveness scores, -12.56 (P=0.0001) in treatment-inconvenience scores, and 0.30 seconds (P=0.5789) in TFBUT. CONCLUSION: The HPG-HA dual-polymer formulation was noninferior to the SH lubricant eye-drops for improvement in ocular surface staining in DED. HPG-HA did not show improvement over SH in IDEEL treatment-satisfaction scores. No new safety findings were reported.

Bilateral implantation of +2.5 D multifocal intraocular lens and contralateral implantation of +2.5 D and +3.0 D multifocal intraocular lenses: Clinical outcomes.

PURPOSE: To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye. SETTING: Multicenter study at 8 investigative sites. DESIGN: Prospective randomized parallel-group patient-masked 2-arm study. METHODS: This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR. RESULTS: In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups. CONCLUSION: Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).

Clinical outcomes and surgeon assessment after implantation of a new diffractive multifocal toric intraocular lens.

PURPOSE: To evaluate the clinical outcome in eyes with significant corneal astigmatism after cataract surgery with implantation of a new diffractive multifocal toric intraocular lens (IOL). METHODS: Prospective, non-randomised multicentre clinical study including 57 eyes of 38 consecutive patients with an age between 37 and 84 years that underwent cataract surgery with implantation of the toric multifocal IOL Tecnis ZMT (Abbott Medical Optics, Santa Ana, California, USA). Changes in uncorrected and corrected logMAR distance, intermediate and near visual acuity ((uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), corrected near visual acuity) and manifest refraction were evaluated during a 2-4 month follow-up. Additionally, patients were asked about photic phenomena and spectacle dependence. The surgeons subjectively assessed various aspects of the surgery. RESULTS: A significant improvement in CDVA was observed postoperatively (p<0.01), with a significant reduction in manifest cylinder (p<0.01). Mean postoperative binocular UDVA and UNVA were 0.04±0.10 and 0.06±0.12, respectively. Monocular UDVA and UNVA was 0.20 or better in 85.4% and 87.0% of eyes, respectively. Mean binocular logMAR UIVA was 0.21±0.20. Only 10.5% of patients required postoperative correction for near or intermediate distance. The incidence of moderate to severe photic phenomena was limited. Surgeons defined the IOL implantation in most cases as easy or very easy, with a satisfaction rate with the procedure of 84%. CONCLUSIONS: The implantation of the multifocal toric IOL is a safe procedure that provides a very good visual rehabilitation in eyes with corneal astigmatism.

Impact of personality characteristics on patient satisfaction after multifocal intraocular lens implantation: results from the "happy patient study".

PURPOSE: This prospective multicenter study assessed personality characteristics that may influence patient satisfaction after implantation of multifocal intraocular lenses (MIOLs). METHODS: One hundred eighty-three patients who underwent bilateral implantation of different MIOLs were enrolled. Uncorrected and corrected distance visual acuity for distance and near (ie, UDVA, UNVA, CDVA, and CNVA) were assessed preoperatively and 3 and 6 months after implantation. Before surgery, personality characteristics were evaluated using a questionnaire based on the NEO Personality Inventory Test and the Compulsiveness Inventory Test. At the 3- and 6-month postoperative visits, patients answered a questionnaire concerning overall satisfaction, need for spectacles at different distances, visual function at different distances and lighting conditions, photic phenomena, and ease of performing daily activities. RESULTS: Three months after surgery (n = 163), mean CDVA was 0.03 ± 0.09 logMAR, UDVA was 0.05 ± 0.09 logMAR, and UNVA was 0.04 ± 0.11 logMAR. At the 6-month visit (n = 131), mean CDVA was 0.02 ± 0.07 logMAR, UDVA was 0.06 ± 0.09 logMAR, and UNVA was 0.05 ± 0.01 logMAR. Most patients (82.2%) would opt for an MIOL again, 3.7% would not, and 14.1% were uncertain. Overall satisfaction with the procedure was correlated to low astigmatism, good visual function, low spectacle dependence, and less halos or glare. The personality characteristics of compulsive checking, orderliness, competence, and dutifulness were statistically significantly correlated to subjective disturbance by glare and halos. CONCLUSIONS: Postoperative patient satisfaction after MIOL implantation is correlated to visual performance, spectacle independence, and less photic phenomena. Personality characteristics have an impact on subjective disturbance by photic phenomena and thus are important for patient satisfaction.

A methodological approach to identify external factors for indicator-based risk adjustment illustrated by a cataract surgery register.

BACKGROUND: Risk adjustment is crucial for comparison of outcome in medical care. Knowledge of the external factors that impact measured outcome but that cannot be influenced by the physician is a prerequisite for this adjustment. To date, a universal and reproducible method for identification of the relevant external factors has not been published. The selection of external factors in current quality assurance programmes is mainly based on expert opinion. We propose and demonstrate a methodology for identification of external factors requiring risk adjustment of outcome indicators and we apply it to a cataract surgery register. METHODS: Defined test criteria to determine the relevance for risk adjustment are "clinical relevance" and "statistical significance". Clinical relevance of the association is presumed when observed success rates of the indicator in the presence and absence of the external factor exceed a pre-specified range of 10%. Statistical significance of the association between the external factor and outcome indicators is assessed by univariate stratification and multivariate logistic regression adjustment.The cataract surgery register was set up as part of a German multi-centre register trial for out-patient cataract surgery in three high-volume surgical sites. A total of 14,924 patient follow-ups have been documented since 2005. Eight external factors potentially relevant for risk adjustment were related to the outcome indicators "refractive accuracy" and "visual rehabilitation" 2-5 weeks after surgery. RESULTS: The clinical relevance criterion confirmed 2 ("refractive accuracy") and 5 ("visual rehabilitation") external factors. The significance criterion was verified in two ways. Univariate and multivariate analyses revealed almost identical external factors: 4 were related to "refractive accuracy" and 7 (6) to "visual rehabilitation". Two ("refractive accuracy") and 5 ("visual rehabilitation") factors conformed to both criteria and were therefore relevant for risk adjustment. CONCLUSION: In a practical application, the proposed method to identify relevant external factors for risk adjustment for comparison of outcome in healthcare proved to be feasible and comprehensive. The method can also be adapted to other quality assurance programmes. However, the cut-off score for clinical relevance needs to be individually assessed when applying the proposed method to other indications or indicators.

Clinical evaluation of a multifocal aspheric diffractive intraocular lens.

AIM: To evaluate the performance of an aspheric diffractive multifocal acrylic intraocular lens (IOL), ZMB00 1-Piece Tecnis. SETTING: Five sites across Europe. METHODS: Fifty-two patients with cataracts (average age 68.5±10.5 years, 35 female) were bilaterally implanted with the aspheric diffractive multifocal IOL after completing a questionnaire regarding their optical visual symptoms, use of visual correction and their visual satisfaction. The questionnaire was completed again 4-6 months after surgery along with measures of uncorrected and best-corrected distance and near visual acuity, under photopic and mesopic lighting, reading ability, defocus curve testing and ocular examination for adverse events. RESULTS: The residual refractive error was 0.01±0.47D with 56% of eyes within ±0.25D and 97% within ±1.0D. Uncorrected visual acuity was 0.02±0.10logMAR at distance and 0.15±0.30 logMAR at near, only reducing to 0.07±0.10logMAR at distance and 0.21±0.25logMAR at near in mesopic conditions.The defocus curve showed a near addition between 2.5-3.0 D allowing a reading acuity of 0.08±0.13 logMAR, with a range of clear vision <0.3 logMAR of ∼4.0 D. The average reading speed was 121.4±30.8 words per minute. Spectacle independence was 100% for distance and 88% for near, with high levels of satisfaction reported. Overall rating of vision without glasses could be explained (r=0.760) by preoperative best-corrected distance acuity, postoperative reading acuity and postoperative uncorrected distance acuity in photopic conditions (p<0.001). Only two minor adverse events occurred. CONCLUSIONS: The ZMB00 1-Piece Tecnis multifocal IOL provides a good visual outcome at distance and near with minimal adverse effects.

Longitudinal change of refraction over at least 5 years in 15,000 patients.

BACKGROUND: To report the natural, longitudinal history of shifts in refractive errors in different age groups in a large western European cohort over at least 5 years in the same patients. METHODS: The electronic database of a large regional clinic containing 225,000 patients was searched for records of patients with a follow-up of at least 5 years, excluding all patients who had received any surgical interventions in any eye. This search retrieved 15,799 patients aged 3 months to 79 years (median 37.8 years) with refractive follow up of at least 5 years (mean 8.8 years) and no surgical interventions. Differences in spherical equivalents (sum of sphere +1/2 cylinder) and cylinder between first and last visit in the same patients in only the right eye were calculated, and used as the measure of refractive shift. Subsequently differences in change between the right and left eye were also determined. RESULTS: Refractions were found to be mostly stable from 25 to 39 years (n = 3,155 right eyes), with 50% of these patients not changing their refraction. In patients aged 20-24 (n = 825 right eyes), only 39% of the refractions remained stable, whereas 49% experienced a myopic shift. In the age group 40-69 years (n = 6,694), 40-45% remained stable, with an increase in hyperopic shifts. Eighty-five percent of all patients had bilateral symmetric shifts, and 61% showed stable cylindrical values. CONCLUSIONS: This report documents clinical relevant changes in spherical equivalents in all age groups within 5 to 10 years in the largest examined European cohort. Refractive surgery patients in particular should be selected accordingly, and be informed about the physiological changes which might still occur during their lifetime.

Determination of valid benchmarks for outcome indicators in cataract surgery: a multicenter, prospective cohort trial.

OBJECTIVE: To evaluate a systematic approach to derive valid benchmarks for 2 outcome indicators intended to ascertain quality in cataract surgery and to propose benchmark levels drawn from the study results. DESIGN: Prospective, multicenter cohort trial. PARTICIPANTS: A total of 1685 patients (206-239 eyes per trial site) were recruited consecutively at 7 study sites. The patients featured age-related cataracts and were undergoing unilateral cataract surgery in the period between January 2007 and August 2008. METHODS: Only patients with uncomplicated age-related cataracts were included. Cataract surgery was performed by phacoemulsification. The SN60AT (Alcon, Inc., Fort Worth, TX) intraocular lens (IOL) was used as a study lens. The IOL power was calculated using the SRK-T formula with a standardized A constant. Biometry was performed with the IOL Master (Carl Zeiss Meditex, Jena, Germany). Only highly experienced senior surgeons were involved. MAIN OUTCOME MEASURES: The outcome indicators 1 month and 3 months after surgery were the respective achievement of: (1) maximum absolute deviation of 0.5 diopter (D) between target refraction and postoperative spherical equivalent (primary end point, refractive accuracy); (2) best-corrected visual acuity of at least 0.8 (secondary end point, visual acuity outcome). RESULTS: In the pooled data, maximum absolute deviation of ± 0.5 D from target refraction was achieved in 80% (95% confidence interval, 78%-82%) of cases. Visual acuity of 0.8 or more was reached in 87% (95% confidence interval, 80%-93%) of cases. The results from the trial centers differed significantly in the outcomes of the primary and secondary end points (P<0.001). CONCLUSIONS: The study quantified benchmark levels for 2 outcome indicators in a standardized cataract surgery procedure. External confounding factors such as the comorbidity of patients, which cannot be influenced by the surgeon, were excluded. The derived benchmarks selectively illustrate the quality of the surgery and are superior to success rates published in the literature from unspecific data collections. This method is more suited for improving outcome quality by benchmarking. General methodologic problems are discussed, leading to recommendations for future study designs. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Retinal detachment after phacoemulsification in high myopia: analysis of 2356 cases.

PURPOSE: To determine the incidence of and risk factors for rhegmatogenous retinal detachment (RD) in highly myopic eyes after cataract surgery. SETTING: Two ophthalmology centers in Munich and Ahaus, Germany. METHODS: This retrospective medical chart review comprised 1519 consecutive patients (2356 eyes) with an axial length (AL) greater than 27.0 mm who had planned phacoemulsification and intraocular lens implantation in the capsular bag. In addition, all patients and/or the referring ophthalmologist were contacted regarding the occurrence of RD and laser capsulotomy and the date of occurrence. RESULTS: Follow-up was longer than 24 months in 84% of eyes. Because some cases of RD were questionably related to the preceding cataract surgery, the absolute incidence of postoperative RD was determined as highest (2.2%) and lowest (1.5%). Sex, history of laser capsulotomy, and increasing AL had no statistically significant effect on the rate of RD. The risk for postoperative RD was significantly higher in eyes of younger patients and eyes with preoperative prophylactic treatment for retinal degeneration. CONCLUSIONS: The risk for postoperative RD in this study (1.5% to 2.2%) corresponds to the incidence of pseudophakic RD and idiopathic RD in myopia described in the literature. The risk profile for postoperative RD in this series cannot be distinguished from the risk profile for idiopathic RD in myopia of this extent. The true effect of prophylactic treatment of degenerative lesions remains to be elucidated.

Postoperative changes in refraction and anterior chamber depth in different multifocal intraocular lenses.

PURPOSE: To investigate the axial shift of multifocal intraocular lenses (IOLs) during the first months after implantation and to determine its potential effect on uncorrected distance visual acuity. METHODS: This study comprised 8 patients (16 eyes) who received the Tecnis multifocal IOL and 8 patients (16 eyes) who received the ReSTOR multifocal IOL. Anterior chamber depth was measured with a Scheimpflug camera, and visual acuity and subjective manifest refraction were determined at 1 day, 1 week, and 1 and 3 months after surgery. RESULTS: The spherical equivalent refraction in the ReSTOR and Tecnis eyes, respectively, was +0.125 +/- 0.412 diopters (D) and +0.306 +/- 0.481 D at day 1, -0.375 +/- 0.280 D and -0.188 +/- 0.438 D at 1 week, -0.475 +/- 0.337 D and -0.018 +/- 0.512 D at 1 month, and 0.297 +/- 0.267 D and -0.036 +/- 0.393 D at 3 months. Anterior chamber depth in the ReSTOR and Tecnis eyes, respectively, was 3.18 +/- 0.1 mm and 3.16 +/- 0.17 mm at day 1, 3.18 +/- 0.10 mm and 3.17 +/- 0.20 mm at 1 week, 3.29 +/- 0.22 mm and 3.18 +/- 0.25 mm at 1 month, and 3.14 +/- 0.19 mm and 3.20 +/- 0.14 mm at 3 months. The change in axial position did not correlate with the change in refraction. CONCLUSIONS: Multifocal IOLs change their axial position slightly during the first postoperative months. The ReSTOR IOL showed a myopic change of approximately -0.50 D during this time period, which did not correlate with the change in axial position.