Long-Term Astigmatism after Intraocular Pressure Sensor Implantation and Nonpenetrating Glaucoma Surgery - EYEMATE-SC Trial.

PURPOSE: To investigate the long-term astigmatism after combined non-penetrating glaucoma surgery (NPGS) and implantation of the first miniaturized suprachoroidal intraocular pressure (IOP) sensor EYEMATE-SC. SETTING: The study was conducted in five medical centers in two different countries. DESIGN: Retrospective multicenter clinical study. METHODS: Astigmatism of patients instrumented with the EYEMATE-SC IOP sensor was assessed over a follow-up period of three years. Refraction and corrected distance visual acuity (CDVA) were obtained preoperatively, after 6 months, 1, 2, and 3 years. A canaloplasty-operated patient cohort served as control. Astigmatism was evaluated using 3-dimensional power vector analysis involving the spherical equivalent M, and the Jackson crossed cylinder projections J0 and J45. Exclusion criteria included neovascular and angle-closure glaucoma, myopia, axial length outside 22 to 26 mm, other ocular diseases, prior glaucoma surgery, other ocular surgery within 6 months (cataract surgery within 3 months) prior to NPGS, serious generalized conditions, and other active medical head/neck implants. RESULTS: Multivariate analysis indicated no changes in astigmatism along the observation period in both the EYEMATE-SC (n = 24) and the canaloplasty (n = 24) group (P > 0.05 or nonsignificant after Bonferroni correction). Astigmatism was unchanged between the EYEMATE-SC and the canaloplasty group at all time points (P > 0.05). CDVA didn't change along the observation period of three years in each of both groups (P > 0.05). CONCLUSIONS: Despite its suprachoroidal localization, the present study indicates that the miniaturized EYEMATE-SC IOP sensor doesn't negatively affect the long-term astigmatism after combined implantation with NPGS.

Two-Year Performance and Safety Results of the MINIject Supraciliary Implant in Patients With Primary Open-Angle Glaucoma: Meta-Analysis of the STAR-I, II, III Trials.

PURPOSE: To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a stand-alone procedure. DESIGN: Meta-analysis. METHODS: At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss. RESULTS: At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%. CONCLUSIONS: This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years.

One-Year Outcomes of PreserfloTM MicroShunt Implantation versus Trabeculectomy for Pseudoexfoliation Glaucoma.

This retrospective, single-center study evaluates the safety and efficacy of PreserfloTM MicroShunt (MicroShunt) implantations compared to trabeculectomies (TETs) in patients diagnosed with pseudoexfoliation glaucoma (PEXG). A total of 31 eyes from 28 patients received a MicroShunt implantation, and 29 eyes from 26 patients received a TET. Surgical success was defined as an intraocular pressure (IOP) between 5 mmHg and 17 mmHg at the end of the follow-up period, no need for surgical revisions or secondary glaucoma surgery, and no loss of light perception. In the MicroShunt group, the mean IOP dropped from 20.8 ± 5.9 mmHg at baseline to 12.4 ± 2.8 mmHg (p < 0.0001) after one year. In the TET group, the mean IOP dropped from 22.3 ± 6.5 mmHg to 11.1 ± 3.7 mmHg (p < 0.0001) after 12 months. In both of the groups, the mean number of medications was reduced significantly (MicroShunt from 2.7 ± 1.2 to 0.2 ± 0.7; p < 0.0001 vs. TET from 2.9 ± 1.2 to 0.3 ± 0.9; p < 0.0001). Considering the success rates, 83.9% of the MicroShunt eyes achieved complete success, and 90.3% qualified for success at the end of the follow-up period. In the TET group, the rates were 82.8% and 93.1%, respectively. The postoperative complications were comparable between both groups. In conclusion, the MicroShunt implantation demonstrated non-inferiority regarding its efficacy and safety profile compared to TET in PEXG at a follow-up of one year.

EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure.

PURPOSE: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS). DESIGN: Prospective, multicenter, open-label, single-arm, interventional clinical trial. PARTICIPANTS: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy). METHODS: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months. MAIN OUTCOME MEASURES: Device position and adverse events. RESULTS: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT. CONCLUSIONS: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Retinal Infarction: A Pilot Study on the Efficacy and Safety of Intravenous Thrombolysis and Underlying Aetiologies.

Background: Treatment of non-arteritic central retinal artery occlusion is still inconsistent. Therefore, the current study aimed to evaluate the efficacy of intravenous thrombolysis (IVT) and describe the prevalence of co-occurring ischemic brain lesions in patients with acute visual loss due to ischemia. Methods: We analysed 38 consecutive patients with acute visual loss between January 2015 and June 2020. Patients presenting within 4.5 h of symptom onset without any contraindication were treated with IVT. Patients underwent neurologic and ophthalmologic examination and diagnostic workup for the underlying aetiology. Follow-up was performed after 3 and 12 months. Results: Patients treated with IVT had a significantly better functional outcome at discharge compared to patients treated conservatively. No additional ischemic brain lesions were detected (0 of 38). Three patients had extracranial carotid artery stenosis ≥50%. Atrial fibrillation was present in four patients, three of whom already received oral anticoagulation. In the remaining 31 patients no embolic source was detected. However, the number of plaques were rated mild to moderate. Within three months, one patient developed transient visual loss while another suffered a contralateral transient ischemic attack. Conclusions: IVT may represent a safe and effective treatment option in patients with isolated visual loss due to ischemia. The aetiology was atherosclerotic burden rather than embolism caused by carotid stenosis or atrial fibrillation, bringing the current diagnostic procedure and therapy into question. Randomized trials are necessary to evaluate the efficacy and safety of IV thrombolysis and clarify the aetiology of isolated visual loss due to ischemia.

Hyperechogenic intimal lesions and wall thickness of the temporal and facial arteries in elderly patients with arterial occlusions of the eye.

OBJECTIVE: To determine the association of arteriosclerosis, characterised by hyperechogenic intimal lesions (HIL), with wall thickness of the temporal and facial arteries in elderly patients with ocular arterial occlusions. METHODS: Patients suffering from non-arteritic ocular perfusion disorders were included. High-resolution compression sonography (18 MHz) images of the temporal arteries (frontal and parietal branch at the upper margin of the auricle) and facial arteries (at the crossing point of the artery over the mandible) were analysed for the presence of HIL (grade 0: absent; grade 1: moderate; grade 2: severe). Characteristics of patients with and without evidence of HIL >grade 1 were compared. RESULTS: In total, 330 cranial artery segments of 55 patients were analysed. HIL ≥grade 1 was present in 13.0% of all artery segments and in 38.1% of all patients. Patients with HIL ≥grade 1 in at least one arterial segment displayed significantly increased maximum wall thickness of the temporal arteries (0.62±0.23 mm vs 0.50±0.13 mm; p<0.01) and facial arteries (0.71±0.20 mm vs 0.54±0.19 mm; p=0.01). Patients with at least one temporal or facial artery segment with HIL were older, more often male and more frequently suffered from diabetes mellitus. CONCLUSION: The presence of HIL goes along with a significantly increased wall thickness of the temporal and facial arteries. These findings should be considered when interpreting the results of sonography of the cranial arteries in the diagnostic workup of suspected giant cell arteritis.

One-year outcomes of microshunt implantation in pseudoexfoliation glaucoma.

PURPOSE: To compare the safety and efficacy of microshunt implantation augmented with Mitomycin C in patients with pseudoexfoliation glaucoma (PEXG) and primary open-angle glaucoma (POAG). METHODS: In this retrospective, single centre, interventional study, 46 eyes of 41 patients with PEXG (20 eyes) and POAG (26 eyes) underwent microshunt implantation. Definition of failure was an intraocular pressure (IOP) lower than 5 or higher than 17mmHg on two consecutive visits, an IOP reduction lower than 20% on two consecutive visits, the need of surgical revisions or reoperations or loss of light perception. Outcome was rated as complete success if achieved without medication, otherwise as qualified success. Furthermore, postoperative complications and interventions were compared between the two groups. RESULTS: Patient demographics were similar, except for older age in the PEXG group (70.9±8.6 versus 77.6±8; p = 0.02). Mean IOP dropped from 21.5±5.8mmHg (PEXG) and 18.2±4.5mmHg (POAG) at baseline to 12.8±3.0mmHg (p<0.0001) and 12.9±4.2mmHg (p<0.0001), respectively, at one year. Mean number of medications were reduced from 2.8±1.3 to 0.3±0.8 for PEXG patients (p<0.0001) and from 2.7±1.3 to 0.3±0.8 for POAG patients (p<0.0001). At one year of follow-up 75.0% of PEXG patients achieved complete success and 80.0% qualified success. In the POAG group rates were 73.1% and 76.9%, respectively. Postoperative complications were comparable between both groups, except for higher rates of hypotony (p = 0.04) and choroidal detachment (p = 0.03) in the PEXG group. CONCLUSION: Microshunt implantation demonstrated similar efficacy results in PEXG and POAG eyes at a follow-up of 12 months. Higher rates of transient hypotony and choroidal detachment were observed in PEXG eyes.

Predictability of Refractive Outcome of a Small-Aperture Intraocular Lens in Eyes With Irregular Corneal Astigmatism.

PURPOSE: To compare different new-generation biometric formulas and ray-tracing for small-aperture intraocular lens (IOL) (IC-8; Acufocus, Inc) implantation in patients undergoing cataract and refractive lens exchange surgery with highly irregular corneas. METHODS: This monocenter study included 17 eyes of 17 patients with highly irregular corneas of different genesis. Biometric and topographic corneal data were assessed using the IOLMaster 700 (Carl Zeiss Meditec) and Pentacam (Oculus Optkigeräte GmbH). Prediction and absolute error were compared after 3 months based on manifest refraction. Furthermore, change of total corneal refractive power in different corneal pathologies was also evaluated. For IOL power calculation, three fourth-generation IOL formulas were compared (Haigis, SRK-T, and Barrett Universal II). The dataset was then checked against ray-tracing and analyzed to improve prediction error in these highly irregular corneas. RESULTS: All patients showed an improvement in visual acuity postoperatively with a mean spherical equivalent of -1.22 ± 0.49 diopters (D). Overall comparison of the three formulas showed the Haigis formula to be superior in terms of the smallest deviation of predictive and absolute error. IOL calculations with ray-tracing were possible in all eyes, but showed inaccurate results with keratometric values of 48.00 D and greater. CONCLUSIONS: The IC-8 IOL is well suited for patients with lens exchange in highly irregular corneas. The Haigis formula seemed to be the most accurate in the patient group. Ray-tracing confirmed the results of biometric formulas up to a keratometric value of 48.00 D and should be compared with standard biometric formulas to address corneal irregularities and to minimize refractive surprises after surgery. A comparison with ray-tracing in eyes with a keratometric value of greater than 48.00 D should not be considered due to the inaccurate results. [J Refract Surg. 2021;37(5):312-317.].

Transocular sonography in acute arterial occlusions of the eye in elderly patients: Diagnostic value of the spot sign.

PURPOSE: To characterize the diagnostic yield of the spot sign in the diagnostic workup of acute arterial occlusions of the eye in elderly patients. METHODS: Clinical characteristics of consecutive patients aged ≥ 50 years with acute central retinal artery occlusion (CRAO), branch retinal artery occlusion (BRAO) or anterior ischemic optic neuropathy (AION) were recorded. Videos of transocular sonography were assessed for the presence of the spot sign by two blinded readers. Group comparisons were made between CRAO-patients with and without the spot sign. Two experienced cardiovascular physicians allocated CRAO-cases to a presumed aetiology, without and with knowledge on the presence/absence of the spot sign. RESULTS: One-hundred-twenty-three patients were included, 46 of whom suffered from CRAO. A spot sign was seen in 32 of 46 of patients with CRAO and in 7 of 23 patients with BRAO. Interobserver agreement was excellent (Cohen`s kappa 0.98). CRAO-patients with the spot sign significantly more frequently had a medical history of cardiovascular disease (62.8 vs. 21.4%, p = 0.03) and left heart valve pathologies (51.9 vs. 10%, p = 0.03). The spot sign was not found in any of the three patients with CRAO secondary to cranial giant cell arteritis. The assumed CRAO aetiology differed in 37% of cases between two cardiovascular physicians, regardless whether transocular sonography findings were known or not. CONCLUSION: The spot sign is a simple sonographic finding with excellent interobserver agreement, which proofs the embolic nature of CRAO, but does not allow exact attribution of the underlying aetiology.

Retrobulbar Spot Sign in Metachronous Bilateral Central Retinal Artery Occlusion of Cardioembolic Origin.

ABSTRACT: A 78-year-old man suffered sudden visual loss of his right eye. Five years earlier, he had experienced vision loss of his left eye due to central retinal artery occlusion (CRAO); back then, the etiology for the CRAO was not established. Current ocular ultrasound depicted a hyperechoic spot within the optic nerve in both eyes. Echocardiography identified a calcified mass adherent to the mitral valve as the embolic source of the CRAO. This case shows the value of ocular B-mode ultrasound in demonstration and proof of the etiology for CRAO.

[Intraocular lens opacification after combined cataract and minimally invasive glaucoma surgery (MIGS)]. / Trübung der Intraokularlinse nach kombinierter Katarakt- und minimal-invasiver Glaukomchirurgie (MIGS).

A visual deterioration due to opacification of the intraocular lens was observed 3 weeks after uncomplicated combined minimally invasive glaucoma and cataract surgery. Due to the patient's failure to apply the prescribed postoperative local anti-inflammatory eyedrops, homogeneous fibrin coating on the anterior surface of the lens occurred, as well as early scarring of the filtering bleb. We performed needling with 5­fluorouracil and lens polishing with the Nd:YAG laser to achieve sufficient pressure control and vision improvement.

Temporal artery compression sonography for the diagnosis of giant cell arteritis in elderly patients with acute ocular arterial occlusions.

OBJECTIVES: To validate cut-off values of quantitative high-resolution temporal artery compression sonography (TCS) for the diagnosis of cranial GCA (cGCA) in patients with acute arterial ocular occlusions and in an independent control group. METHODS: Consecutive patients who underwent TCS as part of the diagnostic workup of acute arterial ocular occlusions and controls not suffering from ocular ischaemia/systemic vasculitis were included. The diagnostic accuracy of the established TCS cut-off value of maximum temporal artery wall thickness (≥0.7 mm) and a novel numeric TCS score incorporating the degree of wall thickening in the four temporal artery segments assessed (0-3 points per segment) was tested by receiver operating characteristics analysis. Subgroup analyses were performed for female and male patients and patients older and younger than age of 70 years. RESULTS: Of 114 patients with acute ocular arterial occlusions, 30 patients received a final clinical diagnosis of cGCA. The sensitivity and specificity of the ≥0.7 mm TCS cut-off for the diagnosis of cGCA were 100 and 84.5% in the overall cohort. The TCS score did not improve the diagnostic yield (cut-off ≥5; sensitivity 100%, specificity 85.7%). In male patients >70 years of age, the specificity of TCS was limited, secondary to age- and sex-related differences in temporal artery wall thickness, which we confirmed in the independent control group. CONCLUSION: TCS yields high diagnostic accuracy in the diagnosis of cGCA in patients with acute ocular arterial occlusions. Age- and sex-related differences in temporal artery wall thickness influence the diagnostic accuracy of TCS.

[Diagnostic work-up in central retinal artery occlusion and ischemic optic neuropathy - what is important?] / Akute okuläre Ischämien ­ was ist wichtig in der internistischen Diagnostik?

Ischemia of the retina in central retinal artery occlusion (CRAO) and of the optic nerve in ischemic optic neuropathy (ION) are common causes of irreversible vision loss in elderly patients and require a thorough diagnostic work-up. First and foremost, giant cell arteritis should be confirmed or ruled out. The further work-up of non-arteritic CRAO and non-arteritic ION (nAION) aims to determine the cardiovascular risk profile. Patients with nAION should be screened for sleep apnoea. In non-arteritic CRAO, the search for embolic sources is the most important diagnostic task. A "white spot sign" seen on transorbital ultrasound confirms the diagnosis of embolic CRAO and rules out an arteritic etiology of CRAO.

Safety and efficacy of a small-aperture capsular bag-fixated intraocular lens in eyes with severe corneal irregularities.

PURPOSE: To implant a small-aperture intraocular lens (IOL) (IC-8) in eyes with severe corneal irregularities to reduce higher-order aberrations and provide better central visual acuity. SETTING: University Hospital, LMU Munich, Germany. DESIGN: Prospective nonrandomized interventional case series. METHODS: Eyes with severe corneal irregularities due to keratoconus, previous penetrating keratoplasty, status postradial keratotomy, or scarring after ocular trauma were enrolled. Exclusion criteria were progressive keratoconus, pseudoexfoliation, glaucoma, maculopathy, reduced endothelial cells (<1800 cells/mm), and central corneal opacity. Conventional phacoemulsification with implantation of the small-aperture IOL was performed. The primary efficacy endpoint was corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA). Secondary endpoints were life quality assessment using the Visual Function Questionnaire-25 and determination of the refractive defocus curve. RESULTS: Seventeen eyes of 17 patients were enrolled. In all 17 patients, CDVA improved from 0.37 ± 0.09 to 0.19 ± 0.06 logarithm of the minimum angle of resolution (logMAR) 3 months postoperatively (P < .0001). Similarly, postoperative UDVA, UIVA, and UNVA improved significantly in 100%, 88%, and 88%, respectively. The defocus curve showed best results at 0.17 logMAR with a defocus of -0.5 diopter. In addition, overall life quality analyses reported less difficulty with activities under reduced optical phenomena conditions. CONCLUSIONS: The small-aperture IOL was a useful option in eyes with severe corneal irregularities, had a high safety index and a high satisfaction rate, and can lead to better visual quality in these cases. Further studies are needed to improve power calculation of this IOL.

OCT angiography in optic disc drusen: comparison with structural and functional parameters.

BACKGROUND: Optic disc drusen (ODD) can cause retinal nerve fibre layer (RNFL) defects with progressive visual field (VF) loss. Microvascular changes are discussed as a cause. We measured the vessel density (VD) of the optic disc in ODD using optical coherence tomography angiography and compared it with a normal population. Another intent was to determine the sensitivity and correlations in comparison with functional (VF) and structural parameters (RNFL, minimum rim width (MRW), ganglion cell complex (GCC)). METHODS: We analysed the VD of 25 patients with ODD and an age-matched control population including 25 healthy participants using AngioVue (Optovue, Fremont, CA, USA). We obtained data about RNFL, GCC, Bruch's membrane opening MRW (Spectralis HRA & OCT; Heidelberg Engineering, Germany) and VF (standard automated perimetry; SITA 24-2). Low image quality and pathologies interfering with the diagnostics were excluded. Parametric data were analysed using the t-test and non-parametric values using the Mann-Whitney U test. Linear regression analysis was used to determine correlations using the Bravais-Pearson test. RESULTS: The VD was significantly reduced in the ODD group especially the peripapillary capillary VD (n=45 vs 50 eyes; mean 43.15% vs 51.70%). Peripapillary RNFL thickness correlated with the VD significantly (r=0.902 (n=44), 0.901 (n=44), 0.866 (n=45)). The RNFL analysis showed a reduction in ODD, especially the superior hemisphere (mean 107 µm, 129 µm; 49 vs 50 eyes). The GCC was significantly lower in the ODD group (n=38 vs 40; mean 87 µm vs 98 µm). Positive correlation between the VD and the GCC was significant (n=37, r=0.532). There is a significant negative correlation (n=19; r=-0.726) between the VD and the pattern standard deviation (PSD). CONCLUSION: This study reveals significant peripapillary microvascular changes in patients with ODD correlating with the RNFL and GCC reduction. There is a negative correlation between the PSD and the VD.

Ocular ischaemic complications in giant cell arteritis: CHADS2-score predicts risk of permanent visual impairment.

OBJECTIVES: To identify independent risk factors for permanent visual loss (PVL) in patients with giant cell arteritis (GCA), with a special focus on sonographic findings of the temporal, carotid and subclavian/axillary arteries, and on established scoring systems of ischaemia risk assessment. METHODS: Consecutive patients with a diagnosis of GCA between 2002 and 2013 were retrospectively identified from a prospectively maintained database. Data on clinical characteristics including ophthalmological findings, laboratory values, and sonographic findings of the temporal, carotid an axillary arteries were extracted. CHADS2- and CHA2DS2-VASc-score were calculated. Clinical, laboratory and sonographic characteristics of patients with and without PVL were compared. Multiple logistic regression models were calculated to identify variables independently associated with PVL. RESULTS: One-hundred-fifty-two patients were included in the analysis. PVL occurred in 30.2% of patients, with anterior ischaemic optic neuropathy as predominant underlying cause (91.3%). The frequency of PVL was strongly dependent on the age at diagnosis, with a significant increase after the age of 70 years. In multivariate analysis, axillary artery vasculitis with an odds ratio (OR) of 0.3 and constitutional symptoms with an OR of 0.1 were negatively associated with PVL. A CHADS2-score of 1 (OR 10.7) or ≥2 (OR 25) was associated with a significantly increased risk of PVL. CONCLUSIONS: The risk of PVL secondary to GCA increases with age but is lower in patients presenting with constitutional symptoms and/or exhibiting axillary artery involvement. The CHADS2-score may help to discriminate patients with low vs. high risk of PVL.

Secondary intraocular lens implantation: a large retrospective analysis.

PURPOSE: To investigate preoperative ocular risk factors and indications for secondary intraocular lens (IOL) implantation and compare postoperative complications, visual and refractive outcomes in a tertiary referral center. METHODS: Patients older than 14 years that underwent secondary IOL implantation and had a minimum follow-up of 3 months were enrolled in this retrospective case series. Preoperative ocular risk factors, indications for surgery, postoperative complications, and visual and refractive outcomes including prediction error (PE) and absolute error (AE) were evaluated. IOLs were fixated in following positions: anterior chamber (AC), retropupillary iris-claw (IC), sulcus, and capsular bag or sclera. RESULTS: One-hundred eighty-two eyes of 174 patients with mean follow-up of 17 ± 13.6 months were evaluated. Leading cause for surgery was IOL dislocation (75%), followed by secondary aphakia (19%) and IOL opacifications (6%). Previous vitrectomy was the major preoperative ocular risk factor (43%). Mean corrected distance visual acuity improved from preoperative 0.68 ± 0.55 to 0.42 ± 0.31LogMAR by the last follow-up (p = 0.001). PE and AE differed highly depending on the indication for surgery (p = 0.041 and p = 0.008, respectively) and the IOL fixation (p = 0.011 and p = 0.028, respectively), with IC-IOLs showing the lowest PE and AE. Postoperative AC-hemorrhage occurred mainly after IC-IOLs (p = 0.003), and postoperative hypotony was significantly higher in eyes with previous uveitis (p = 0.026). CONCLUSIONS: Previous vitrectomy seems to be a major underreported risk factor in eyes that undergo secondary IOL implantation. Refractive outcomes depend on indication for surgery and fixation type, with retropupillary IC-IOLs providing the best refractive results, though not statistically significant compared to other IOL positions.

Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus.

BACKGROUND: Corneal cross-linking is widely used to treat keratoconus. However, to date, only limited data from randomized trials support its efficacy. METHODS: The efficacy and safety of corneal cross-linking for halting progression of keratoconus were investigated in a prospective, randomized, blinded, placebo controlled, multicentre trial. Twenty-nine keratoconus patients were randomized in three trial centres. The mean age at inclusion was 28 years. Longitudinal changes in corneal refraction were assessed by linear regression. The best corrected visual acuity, surface defects and corneal inflammation were also assessed. These data were analysed with a multifactorial linear regression model. RESULTS: A total of 15 eyes were randomized to the treatment and 14 to the control group. Follow-up averaged 1098 days. Corneal refractive power decreased on average (+/-standard deviation) by 0.35 +/- 0.58 dioptres/year in the treatment group. The controls showed an increase of 0.11 +/- 0.61 dioptres/year. This difference was statistically significant (p = 0.02). CONCLUSIONS: Our data suggest that corneal cross-linking is an effective treatment for some patients to halt the progression of keratoconus. However, some of the treated patients still progressed, whereas some untreated controls improved. Therefore, further investigations are necessary to decide which patients require treatment and which do not. TRIAL REGISTRATION: NCT00626717, Date of registration: February 20, 2008.