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.

Does Diabetes Influence Adherence in Glaucoma Patients? / Beeinflusst Diabetes mellitus die Adhärenz von Glaukompatienten?

With chronic diseases, patient adherence plays a crucial role in delaying disease progression and in determining the success of therapy. Problems arise not only from low medication adherence, but also non-adherence to recommended follow-up examinations. Obtaining an accurate estimate of adherence is difficult, especially in glaucoma patients, due to the fact that most antihypertensive drugs are administered in the form of eye drops. There is great variability in the published adherence values for glaucoma patients. Most studies report an average medication adherence of approximately 70%, with around 50% of patients having good adherence (at least 80% of medication administered as planned). Furthermore, 6.8 - 31.4% of the eye drops do not end up in the patient's eye, which means there is even less active ingredient to achieve a therapeutic effect. Glaucoma patients also show low persistence and adherence to follow-up appointments. Since diabetes increases the risk for POAG and secondary glaucoma and given that diabetics have particularly low adherence, the question arose whether a diabetes diagnosis is associated with reduced adherence in glaucoma patients. Previous studies found no significant association between diabetes and reduced adherence in glaucoma patients, although a significant impact of elevated HbA1c on adherence in glaucoma patients was found in one study. However, this connection still needs to be examined more closely in studies with larger samples.

Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial.

BACKGROUND/AIMS: The current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma. METHODS: This prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication. RESULTS: Mean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (-40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm2 (n=26) to 2341 cells/mm2 (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD. CONCLUSION: This first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events. TRIAL REGISTRATION NUMBER: NCT03193736.

What would an 'ideal' glaucoma examination be like? - A conjoint analysis of patients' and physicians' preferences.

PURPOSE: To structurally determine patients' and physicians' preferences for glaucoma diagnostic methods in order to improve glaucoma patient care and improve patient compliance with follow-up visits. METHODS: Forty-one patients with glaucoma and 32 ophthalmologists were included in this cross-sectional study. Profiles representing glaucoma examinations were created using conjoint analysis (CA). The following factors of a glaucoma examination method were evaluated: (1) examination comfort, (2) examination frequency, (3) follow-up examination necessary in case of suspicious result, (4) cost for the patient, (5) travel time to examination site, (6) sensitivity and (7) specificity of the examination method. RESULTS: Preferences were highest in both groups for examination sensitivity, followed by cost and specificity for the patient group. For the physician group, specificity was second most important, followed by cost. Least important was travel time for the patients and follow-up examinations for the physicians. CONCLUSIONS: Participants would rather pay more and travel longer to get a highly sensitive examination. This form of care is present in university eye hospitals. Consequently, it would be advisable to enhance capacities of these centers. Outpatient practices that offer glaucoma service should be fully equipped and should employ a glaucoma specialist.

Changes of Neuroretinal Rim and Retinal Nerve Fiber Layer Thickness Assessed by Optical Coherence Tomography After Filtration Surgery in Glaucomatous Eyes.

PURPOSE: Lowering the intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) with filtration surgery can induce morphological changes to the bulbus and structures of the retina. In this study, we have evaluated changes of Bruch's membrane-based parameters and retinal nerve fiber layer (RNFL) derived by spectral-domain optical coherence tomography (SD-OCT) in eyes that have undergone glaucoma filtration surgery. PATIENTS AND METHODS: SD-OCT imaging of the optic nerve head (ONH) and of the RNFL was performed in 54 eyes of 54 patients with medically uncontrolled POAG before and after IOP-lowering surgery (trabeculectomy or deep sclerectomy). The ONH parameter minimum rim width (MRW) and the size of the Bruch's membrane opening (BMO-Area) were derived from 24 radial B-scans centered on the ONH. RESULTS: The average preoperative IOP was 23.1 ± 7.5 mmHg. One month postoperatively, the average IOP decreased to 12.1 ± 4.6 mmHg (p < 0.01), which caused a significant increase in the thickness of neuroretinal rim. There was no significant change in the automatically detected BMO-Area (p = 0.32). The pressure-related increase in MRW correlated well with the postoperative IOP and cup-to-disc ratio (CDR). In regression analysis, the alteration in thickness of the neuroretinal rim could be well predicted in a model including CDR, change of IOP and mean deviation (MD) (R2 = 0.414, p < 0.001). RNFL showed a significant increase as well. CONCLUSION: IOP-lowering surgery in patients with medically uncontrolled POAG causes an increased thickness of the SD-OCT derived ONH parameters. The changes of the RNFL after surgery showed no significant correlations with IOP changes. In contrast to this, highly significant correlations of MRW values with the IOP could be observed. The BMO-Area remained completely stable A preferred use of RNFL for follow-up should be discussed.

A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II).

PRECIS: In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary minimally invasive glaucoma surgery device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma. PURPOSE: This study evaluates the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627) for surgical treatment of primary open-angle glaucoma in patients refractory to topical hypotensive medications. METHODS: In a prospective, interventional, single-arm, multicenter, European study (STAR-II), MINIject was successfully implanted in a stand-alone procedure in 29 of 31 patients in 8 sites in 3 countries. The primary endpoint was the success rate 6 months after surgery >60% (defined as diurnal IOP ≤21 and >5 mm Hg with ≥20% IOP reduction from baseline, with/without glaucoma hypotensive medication). ClinicalTrials.gov: NCT03624361. RESULTS: At the 6-month follow-up, the primary endpoint was fulfilled, with 75.9% of patients reaching prospectively defined success. The mean IOP was reduced by 40.2% (9.9 mm Hg) to 14.7±6.0 mm Hg at 6 months from 24.6±3.8 mm Hg at baseline. The use of IOP-lowering medication ingredients was reduced by 63.4% from 2.9±1.2 at baseline to 1.0±1.3. Furthermore, 79.3% of the patients had mean IOP ≤18 mm Hg, 82.8% achieved a ≥20% IOP reduction, and 55.2% were medication free at 6 months. Six device-related serious adverse events were reported in the study eye: IOP increase (3/31 patients, 9.7%), and single reports of eye pain, corneal erosion, and chorioretinal folds (1/31, 3.2%), all of which resolved. There was minimal change to corneal endothelial cell density. CONCLUSION: Ab-interno supraciliary surgical implantation using MINIject DO627 in a stand-alone procedure significantly lowers IOP by 40% at the 6-month follow-up, while reducing the need for IOP-lowering medication.

A First-in-Human Study of the Efficacy and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-I).

PURPOSE: To describe the safety and efficacy of a novel, supraciliary, microinvasive glaucoma surgery drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in the study. DESIGN: Prospective, multicenter, interventional, single-arm trial. PARTICIPANTS: Twenty-six patients with primary open-angle glaucoma uncontrolled with 1 or more intraocular pressure (IOP)-lowering medications. METHODS: Using an ab interno approach, 25 eyes were implanted successfully in a stand-alone procedure with a 5-mm long device made of biocompatible STAR material, which is soft and flexible silicone in a microporous, network design. Intraocular pressure, medication use, and other ocular parameters were evaluated before surgery, 1 day, 1 and 2 weeks, and 1, 3, and 6 months after surgery. MAIN OUTCOME MEASURES: Intraocular pressure reduction at 6 months compared with baseline analyzed using a paired t test. Safety evaluation entailed tabulation of the nature and frequency of adverse events. RESULTS: Mean baseline diurnal IOP was 23.2 mmHg (standard error, 0.6 mmHg) using a mean ± standard deviation of 2.0±1.1 IOP-lowering medication classes. During the 6-month follow-up period, mean IOP ranged from 10.0-16.3 mmHg (mean reductions, 6.9-13.2 mmHg or 31.0%-56.8%). Six months after surgery, mean diurnal IOP was 14.2 mmHg (standard error, 0.9 mmHg), equivalent to a reduction of 9.0 mmHg or 39.1% (P < 0.0001). The mean ± standard deviation number of IOP-lowering medications was 0.3±0.7. Of 24 patients seen at 6-month follow-up, 21 (87.5%) were medication-free and 23 (95.8%) achieved a minimum 20% IOP reduction from baseline. There were no serious adverse events related to the device or procedure, and no additional glaucoma surgery was required. Frequently reported events included anterior chamber inflammation (n = 8), IOP elevation (n = 6), of which 1 event was an IOP spike per protocol, visual acuity reduction (n = 3), and hyphema (n = 3), all of which resolved. There was no change to mean central or peripheral corneal endothelial cell density. No device-related adverse events were reported. CONCLUSIONS: The MINIject glaucoma drainage system significantly lowered IOP and eliminated the need for medication in most patients 6 months after surgery when implanted in a standalone procedure. There were no serious ocular adverse events.

Patient-reported prevalence of metamorphopsia and predictors of vision-related quality of life in vitreomacular traction: a prospective, multi-centre study.

OBJECTIVES: To report the prevalence and severity of metamorphopsia, estimate its impact on vision-related quality of life (VRQoL) and evaluate predictors of VRQoL in patients with vitreomacular traction (VMT). PATIENTS AND METHODS: A prospective, cross-sectional multi-centre study in the United Kingdom of 185 patients with VMT, with or without a full thickness macular hole (FTMH). Self-reported metamorphopsia was determined using the metamorphopsia questionnaire. VRQoL was assessed using the Visual Function Questionnaire (VFQ-25). Physicians recorded clinical and ocular characteristics in both eyes including a physician assessment of metamorphopsia. ANOVA and predicted least-squares means were used to estimate the impact of metamorphopsia on VRQoL. Predictors of VRQoL were assessed using ordinary-least-squares regression adjusting for clinically important variables. RESULTS: The prevalence of self-reported metamorphopsia was 69.7% (95% CI 62.6-76.3%) and was higher in eyes with a concomitant FTMH vs. without FTMH (85.4% vs. 64.2%). Physician assessment of metamorphopsia was 53.0% (95% CI: 45.5-60.3%). Comparing eyes with metamorphopsia vs. without metamorphopsia, the VFQ-25 composite score was lower (82.3 vs. 91.4), and mean VA (LogMAR) was worse (0.44 vs. 0.33). The largest difference in VFQ-25 scores was observed for near activities (metamorphopsia: 75.3, No metamorphopsia: 90.2). The adjusted model showed that metamorphopsia severity and age were significantly associated with lower VFQ-25 scores. CONCLUSION: Metamorphopsia was highly prevalent in patients with VMT and associated with significantly lower VRQoL. Physician assessment of symptoms underestimated the self-reported presence of metamorphopsia. Metamorphopsia severity acts as a predictor of impaired VRQoL, over and above decrements due to reduced vision.

[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

Using Electronic Health Records to Build an Ophthalmologic Data Warehouse and Visualize Patients' Data.

PURPOSE: To develop a near-real-time data warehouse (DW) in an academic ophthalmologic center to gain scientific use of increasing digital data from electronic medical records (EMR) and diagnostic devices. DESIGN: Database development. METHODS: Specific macular clinic user interfaces within the institutional hospital information system were created. Orders for imaging modalities were sent by an EMR-linked picture-archiving and communications system to the respective devices. All data of 325 767 patients since 2002 were gathered in a DW running on an SQL database. A data discovery tool was developed. An exemplary search for patients with age-related macular degeneration, performed cataract surgery, and at least 10 intravitreal (excluding bevacizumab) injections was conducted. RESULTS: Data related to those patients (3 142 204 diagnoses [including diagnoses from other fields of medicine], 720 721 procedures [eg, surgery], and 45 416 intravitreal injections) were stored, including 81 274 optical coherence tomography measurements. A web-based browsing tool was successfully developed for data visualization and filtering data by several linked criteria, for example, minimum number of intravitreal injections of a specific drug and visual acuity interval. The exemplary search identified 450 patients with 516 eyes meeting all criteria. CONCLUSIONS: A DW was successfully implemented in an ophthalmologic academic environment to support and facilitate research by using increasing EMR and measurement data. The identification of eligible patients for studies was simplified. In future, software for decision support can be developed based on the DW and its structured data. The improved classification of diseases and semiautomatic validation of data via machine learning are warranted.

Structure-Function Relationship between Flicker-Defined Form Perimetry and Spectral-Domain Optical Coherence Tomography in Glaucoma Suspects.

PURPOSE: To evaluate the relationship between functional parameters of repeated flicker-defined form perimetry (FDF) and structural parameters of spectral-domain optical coherence tomography (SD-OCT) in glaucoma suspects with normal findings in achromatic standard automated perimetry (SAP). METHODS: Patients with optic nerve heads (ONH) clinically suspicious for glaucoma and normal SAP findings were enrolled in this prospective study. Each participant underwent visual field (VF) testing with FDF perimetry, using the Heidelberg Edge Perimeter (HEP, Heidelberg Engineering, Heidelberg, Germany) at two consecutive visits. Peripapillary RNFL thickness was obtained by SD-OCT (Spectralis, Heidelberg Engineering, Heidelberg, Germany). Correlations and regression analyses of global and sectoral peripapillary RNFL thickness with corresponding global and regional VF sensitivities were investigated. RESULTS: A consecutive series of 65 study eyes of 36 patients were prospectively included. The second FDF test (HEP II) was used for analysis. Cluster-point based suspicious VF defects were found in 34 eyes (52%). Significant correlations were observed between mean global MD (PSD) of HEP II and SD-OCT-based global peripapillary RNFL thickness (r = 0.380, p = 0.003 for MD and r = -0.516, p < 0.001 for PSD) and RNFL classification scores (R2 = 0.157, p = 0.002 for MD and R2 = 0.172, p = 0.001 for PSD). Correlations between mean global MD and PSD of HEP II and sectoral peripapillary RNFL thickness and classification scores showed highest correlations between function and structure for the temporal superior and temporal inferior sectors whereas sectoral MD and PSD correlated weaker with sectoral RNFL thickness. Correlations between linear RNFL values and untransformed logarithmic MD values for each segment were less significant than correlations between logarithmic MD values and RNFL thickness. CONCLUSIONS: In glaucoma suspects with normal SAP, global and sectoral peripapillary RNFL thickness is correlated with sensitivity and VF defects in FDF perimetry.

Pemphigus Autoantibodies Induce Blistering in Human Conjunctiva.

PURPOSE: The autoimmune blistering skin disease pemphigus vulgaris (PV) is caused by autoantibodies against desmosomal adhesion molecules. Patients may suffer conjunctival involvement, yet the underlying mechanisms are largely unclear. We characterized human and murine conjunctiva with respect to the PV autoantigens, and evaluated the effects and mechanisms of PV autoantibodies applied to human conjunctiva ex vivo. METHODS: We obtained human conjunctiva specimens from surgical explants and established a short-term culture model to study the alterations induced by antibody fractions of PV patients (PV-IgG). Furthermore, we applied a mouse model depleted of the desmosomal cadherin desmoglein 3 (Dsg3), the primary autoantigen in PV. Murine and human conjunctiva also was used to analyze the expression pattern of desmosomal proteins by immunostaining and Western blotting. RESULTS: Human and murine conjunctiva samples expressed the majority of desmosomal molecules with an expression pattern similar to the epidermis. Interestingly, Dsg3 knock out animals frequently suffer eye lesions, histologically evident as microblisters in the eyelid epidermis and conjunctiva. Incubation of human specimens with PV-IgG for 12 hours caused blistering in the suprabasal layers of the conjunctiva as well as reduction of Dsg1 and Dsg3 protein levels. Furthermore, PV-IgG prompted activation of p38MAPK in the conjunctiva, which is a central pathomechanism leading to blistering in the epidermis. CONCLUSIONS: PV-IgG leads to blister formation and p38MAPK activation in the conjunctiva and, thus, resembles the effects found in the epidermis. Our data indicate that the ocular involvement observed in PV patients is mainly based on conjunctival blistering.

The influence of a specific ophthalmological electronic health record on ICD-10 coding.

BACKGROUND: A specific Electronic Health Record (EHR) for ophthalmology was introduced in an academic center in Germany. As diagnoses coding corresponding to the International Classification of Diseases Version 10 (ICD-10) is mandatory for billing reasons in Germany, we analyzed whether a change occurred in the diversity and number of diagnoses after the EHR introduction. The number of patients was also analyzed. Proper diagnoses coding is of the utmost importance for further data analysis or billing. METHODS: Graphical User Interfaces (GUIs) were created by using Advanced Business Application Programming language in EHR "i.s.h.med." Development of an EHR was conducted in close collaboration between physicians and software engineers. ICD-10 coding was implemented by using a "hit list" and a search engine for diagnoses. An observational analysis of a 6-month period prior to and after the introduction of an ophthalmological specific EHR was conducted by investigating the diversity and number of diagnoses in various ophthalmological disease categories and the number of patient consultations. RESULTS: During the introduction of a specific ophthalmological EHR, we observed a significant increase in the emergency department cases (323.9 vs. 359.9 cases per week), possibly related to documentation requirements. The number of scheduled outpatients didn't change significantly (355.12 vs. 360.24 cases per week). The variety of diagnoses also changed: on average, 156.2 different diagnoses were made per week throughout our hospital before the EHR launch, compared to 186.8 different diagnoses per week thereafter (p < 0.05). Additionally, a significantly higher number of diagnoses per case and per week were observed in both emergency and subspecialty outpatient clinics (1.15 vs. 1.22 and 1.10 vs. 1.47, respectively). CONCLUSIONS: An optimized EHR was created for ophthalmological needs and for simplified ICD-10 coding. The implementation of digital patient recording increased the diversity of the diagnoses used per case as well as the number of diagnoses coded per case. A general limitation to date is the suboptimal precision of ICD-10 coding in ophthalmology. Correct coding is of utmost importance for future data analysis.

Structure-Function Relationship Between Bruch's Membrane Opening-Based Optic Nerve Head Parameters and Visual Field Defects in Glaucoma.

PURPOSE: This study was performed to evaluate the structure-function relationship between Bruch's membrane opening (BMO) parameters of the optic nerve head (ONH) and visual field (VF) sensitivity. METHODS: Forty-six right eyes of 46 patients with open-angle glaucoma (OAG) in the patient group and 12 right eyes in the control group were included. Standard automated perimetry (SAP) and spectral-domain optical coherence tomography (SD-OCT) were assessed. Three BMO-based distances and two areas of the neuroretinal rim were used for correlation: the minimum rim width (MRW), the perpendicular rim width (PRW), the horizontal rim width (HRW), the minimum rim area (MRA) within the neuroretinal tissue defined by the MRW, and the perpendicular rim area (PRA) within the neuroretinal tissue defined by the PRW. These parameters were correlated with global and sectoral VF sensitivities. Spearman's correlation coefficients between BMO parameters and global and sectoral VF sensitivities were obtained. RESULTS: Within the patient group, significant correlations could be observed between global and sectoral VF sensitivities and BMO parameters, with PRW and PRA showing the highest values. In the sectoral analysis the highest correlations were found for the temporal-inferior VF sector (MD-TI): PRW-TI (ρ = 0.72394; P < 0.00001) and PRA-TI (ρ = 0.77205; P < 0.00001). Minimum rim width and MRA performed more weakly than PRW and PRA. CONCLUSIONS: The BMO-based parameters PRW and PRA presented with a very good structure-function relationship in glaucoma patients, statistically at least equal to MRW and MRA. Using new BMO-based parameters might allow early objective assessments of functional glaucomatous impairments.

Flicker defined form perimetry in glaucoma suspects with normal achromatic visual fields.

BACKGROUND: To evaluate if repeated flicker-defined form (FDF) perimetry can detect visual field (VF) defects in glaucoma suspects with normal findings in achromatic standard automated perimetry (SAP). METHODS: Patients with optic nerve heads (ONHs) or retinal nerve fiber layer (RNFL) findings clinically suspicious for glaucoma and normal SAP were enrolled. Patients underwent VF testing with FDF perimetry (Heidelberg Edge Perimetry, HEP) at two consecutive visits (HEP I and HEP II) and confocal scanning laser ophthalmoscopy with the Heidelberg Retina Tomograph (HRT). Abnormal HEP was defined by cluster-point analysis (CPA) and by the HEP specific glaucoma hemi-field test (GHT). Results were compared with an age-matched control group of healthy individuals. RESULTS: In 65 eyes of 36 glaucoma suspects, the mean deviation (MD) in SAP was -0.9 ± 1.3 dB. In HEP I and HEP II, mean MD was -3.6 ± 3.0 and -3.3 ± 3.7 dB, respectively (p = 0.276). The HRT assessed CDR was significantly correlated with the MD in HEP II (r = -0.281, p = 0.04). In HEP I, VF defects on CPA testing were found in 38 study eyes (58.5%). In HEP II, 34 eyes (51.8%) had VF defects on CPA testing. In 46 eyes of 46 age-matched healthy individuals in the control group, the mean MD was -0.2 ± 1.1 and -1.6 ± 2.3 dB in SAP and HEP testing, respectively. The FDF was abnormal in 21.7% in the control group compared to 58.5% in the glaucoma suspect group in HEP I. CONCLUSIONS: In more than half of the patients with ONHs or RNFLs clinically suspicious for glaucoma and normal SAP second FDF perimetry depicts VF defects.

The impact of a better-seeing eye and a worse-seeing eye on vision-related quality of life.

PURPOSE: Patients with eye diseases often have a better-seeing eye (BSE) and a worse-seeing eye (WSE). This review will carve out the current knowledge in which the relationship to BSEs and WSEs contributes to overall visual functioning and vision-related quality of life (VRQoL). METHODS: Searches were from database inception to the current date. Terms used for the search were "better eye", "worse eye", "utility", "life quality", "quality of life", "VFQ-25", and "visual acuity". RESULTS: There is a lack of a clear definition for BSE and WSE, and the used definitions are regularly dependent on the underlying eye disease. "BSE" and "WSE" can interact in terms of binocular inhibition or summation. Measured influences of the BSE and WSE on VRQoL are dependent on the underlying instrument used for the measurement. Several studies show impaired VRQoL if only one eye is affected from disease, with unimpaired vision of the BSE. VRQoL can improve significantly when treating the BSE and the WSE. In eye diseases with impairment of the central vision, there is a better correlation between the BSE and VRQoL. However, in eye diseases with peripheral vision impairment, eg, glaucoma, functional parameters of the WSE are better predictors for VRQoL. CONCLUSION: The WSE appears to have a stronger influence on VRQoL than is generally assumed. This is especially the case if the underlying eye disease does not affect central vision but peripheral vision.

Assessment of ß-zone peripapillary atrophy by optical coherence tomography and scanning laser ophthalmoscopy imaging in glaucoma patients.

PURPOSE: To assess ß-zone peripapillary atrophy (ß-PPA) using spectral domain optical coherence tomography (SD-OCT), scanning laser ophthalmoscopy (SLO), and fundus auto-fluorescence (FAF) imaging in patients with primary open-angle glaucoma with advanced glaucomatous visual field defects. METHODS: A consecutive, prospective series of 82 study eyes with primary open-angle glaucoma were included in this study. All study participants underwent a full ophthalmic examination followed by SD-OCT, wide-field SLO, and FAF imaging of the optic nerve head and the peripapillary region. RESULTS: Eighty-four glaucomatous eyes were included in our prospective study. Correlation analyses for horizontally and vertically obtained ß-PPA for all three imaging modalities (color SLO, FAF, and SD-OCT) revealed highest correlations between FAF and color SLO (Pearson correlation coefficient: 0.904 [P<0.001] for horizontal ß-PPA and 0.786 [P<0.001] for vertical ß-PPA). Bland-Altman plotting revealed highest agreements between color SLO and FAF, with -2.1 pixels ±1.96 standard deviation (SD) for horizontal ß-PPA, SD: 10.5 pixels and 2.4 pixels ±1.96 SD for vertical ß-PPA. CONCLUSION: ß-PPA can be assessed using en-face SLO and cross-sectional SD-OCT imaging. Correlation analyses revealed highest correlations between color SLO and FAF imaging, while correlations between SLO and SD-OCT were weak. A more precise structural definition of ß-PPA is needed.