LONG-TERM EFFICACY OF FLUOCINOLONE IN EYES WITH IRIS-LENS DIAPHRAGM DISRUPTION AND PCME WITH MEDICATION FIXED IN THE SCLERA (MEFISTO).

PURPOSE: The aim of our prospective off-label, interventional clinical trial was to evaluate the efficacy and safety of the fluocinolone-loop-anchoring technique over two years in eyes with iris-lens diaphragm disruption and pseudophakic cystoid macular edema. METHODS: In 10 eyes, scleral fixation of fluocinolone implant was performed. Main outcome measures were the development of best-corrected visual acuity (BCVA), central retinal thickness over 24 months, and general safety of the procedure. RESULTS: A significant improvement to 0.57 ± 0.38 log MAR (Snellen 20/80) (range 0-1.30) was observed (P = 0.003) at 1 month. Further improvement to 0.45 ± 036 log MAR (Snellen 20/60) was observed until month 18 (P = 0.081). Mean central retinal thickness decreased by 22% from 601.6 ± 235.5 µm to 449.1 ± 128.9 µm at 1 month. In one patient, the implant has to be removed at Month 7 because of elevated intraocular pressure and one patient after globe rupture had a retinal redetachment at Month 4. CONCLUSION: In this study, we showed that the treatment of recalcitrant pseudophakic cystoid macular edema with scleral fixated fluocinolone implant in eyes with disruption of the iris-lens diaphragm provides good anatomical and functional results with a reasonable safety profile over 24 months in eyes where pseudophakic cystoid macular edema is otherwise difficult to treat and often left untreated.

Subthreshold laser therapy with a standardized macular treatment pattern in chronic central serous chorioretinopathy.

PURPOSE: There is an ongoing controversial debate about the effectiveness of laser treatments in chronic central serous chorioretinopathy (cCSC). We performed a prospective non-randomized interventional study to learn about the effects of a subthreshold laser treatment (Topcon Endpoint Management™, Topcon Healthcare Inc., Tokyo, Japan) in patients with cCSC. METHODS: Patients with cCSC and a minimum symptom duration of 4 months were included and treated with a standardized laser pattern covering the macular area. Retreatment was performed every 3 months if persistent subretinal fluid was observed. The primary endpoint was resolution of subretinal fluid at 6 months. Further outcome parameters included best corrected visual acuity, microperimetry, central macular and subfoveal choroidal thickness. RESULTS: A total of 42 eyes of 39 patients were included. Mean patient age was 48 ± 10.6 years (range 25-67). Mean symptomatic time before inclusion into the study was 134 ± 133.4 weeks (16-518). Before inclusion, 78.6% of the patients had failed to resolve subretinal fluid under mineralocorticoid receptor antagonists and 14.3% had a recurrence after half-dose photodynamic therapy. Complete resolution of subretinal fluid was observed in 42.9% at 6 months and in 53.8% at 12 months after baseline. Central retinal thickness decreased from 398 ± 135 µm to 291 ± 68 µm (p < 0.001), subfoveal choroidal thickness changed slightly (430 ± 116 µm to 419 ± 113 µm, p = 0.026), microperimetry-derived macular function improved by 19.1 ± 4.7 dB to 21.3 ± 4.8 dB (p = 0.008) and mean BCVA improved by 4.9 ± 8.6 ETDRS letters (p < 0.001). CONCLUSION: The results show that the investigated laser treatment is effective in reducing subretinal fluid and leads to an improvement of functional parameters.

Vanishing pachy-choroid in pachychoroid neovasculopathy under long-term anti-vascular endothelial growth factor therapy.

BACKGROUND: To investigate the diagnostic value of choroidal thickness in the definition of pachychoroid neovasculopathy (PNV), especially in eyes treated with anti-vascular endothelial growth factor (VEGF) therapy. METHODS: Twenty-two consecutive eyes of 11 patients with uni- or bilateral PNV were analyzed. Anti-VEGF treatment was correlated with changes in choroidal thickness on enhanced depth imaging optical coherence tomography. RESULTS: There were 14 eyes with PNV and 8 non-neovascular partner eyes. Mean age was 64.2 ± 4.0 (range: 60-72), total follow-up was 1.8 ± 0.4 (1-2) years. In PNV eyes, choroidal thickness at baseline was 400 ± 58 (269-485) µm. After two years and 13 anti-VEGF injections on average, a mean reduction of - 39 ± 10 (- 26 to - 56) % to final 241 ± 52 (162-327) µm was observed (p < 0.0001). Meanwhile, choroidal thickness in the partner eyes remained stable (p > 0.13 for all comparisons). A significant correlation of choroidal thinning and anti-VEGF injection rate was observed at year one (r = - 0.79; R2 = 0.63; p = 0.00073) and two (r = - 0.69; R2 = 0.48; p = 0.019). While 85.7% of PNV eyes exceeded a pachychoroid threshold of ≥350 µm at baseline, this figure dropped to 21.4% at year one and 0% at year two. CONCLUSION: In PNV, choroidal thickness significantly decreases with anti-VEGF therapy, resembling a "vanishing pachy-choroid", and thus does not represent a valid long-term diagnostic criterium, especially when differentiating PNV from nAMD.

Response of neovascular central serous chorioretinopathy to an extended upload of anti-VEGF agents.

PURPOSE: To determine the anatomical and functional outcomes of an extended 6-month intravitreal anti-vascular endothelial growth factor (anti-VEGF) upload in choroidal neovascularization (CNV) secondary to chronic central serous chorioretinopathy (CSCR). METHODS: A retrospective database analysis was performed applying the following inclusion criteria: (1) diagnosis of CSCR, (2) diagnosis of secondary CNV, and (3) treatment of at least six consecutive injections of anti-VEGF. Outcome measures included the change of central retinal subfield thickness, remodeling of the pigment epithelium detachments, and change in visual function. RESULTS: Twenty-one eyes of 21 patients were included. Mean patient age was 65 ± 8.3 years, and 35% of the patients (n = 8) were female. Mean disease duration before diagnosis of CNV was 48 ± 25.3 months. Mean central retinal thickness decreased from 346 ± 61 to 257 ± 57 µm (p < 0.01) after the sixth injection while mean visual acuity improved from 0.65 ± 0.35 to 0.49 ± 0.29 (logMAR; p < 0.01). Of note, an extended upload of six as opposed to three injections yielded an additional mean central retinal thickness reduction (280 ± 46 µm vs. 257 ± 57 µm, p = 0.038). Significant CNV remodeling was observed as a decrease in pigment epithelium detachment (PED) vertical (p = 0.021) and horizontal diameter (p = 0.024) as well as PED height (p < 0.01). CONCLUSION: An extended anti-VEGF upload of six consecutive injections seems to be effective in inducing CNV remodeling and fluid resorption in CNV complicating chronic CSCR.

COMPLIANCE AND ADHERENCE OF PATIENTS WITH DIABETIC MACULAR EDEMA TO INTRAVITREAL ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY IN DAILY PRACTICE.

PURPOSE: We assessed differences in compliance and adherence (lateness of patients, visual acuity, reasons for abstaining) between patients with diabetic macular edema (DME) and patients with age-related macular degeneration (AMD), both under anti-vascular endothelial growth factor therapy. METHODS: We included 136 patients with DME (36% women, 65 years, 22 visits, 13.9 injections, and 29.9 months of follow-up) and 109 patients with AMD (59% women, 76 years, 20 visits, 14.7 injections, and 22.3 months of follow-up) (minimum follow-up of 12 months and at least 5 injections). We assessed missed appointments (lateness >14 days) and therapy break-offs (lateness >100 days). All delayed patients were called and interviewed for abstaining reasons. RESULTS: Forty-six percent of patients with DME and 22% of patients with AMD had at least one break-off. Thirty-five percent of patients with DME and 50% of patients with AMD were always on schedule. In patients with DME, there was significant correlation (P = 0.017) between the number of break-offs and change of visual acuity. In 60% DME and 38% AMD of break-off cases, visual acuity was worse than the before break-off. The most common reason for abstaining was comorbidities (33% AMD and 20% DME). CONCLUSION: There are significant differences between patients with AMD and DME regarding compliance and adherence, which also affects outcome. Strategies to tie patients with DME to costly intravitreal therapy need to be developed to improve outcomes and efficacy.

Long-term results and recurrence rates after spironolactone treatment in non-resolving central serous chorio-retinopathy (CSCR).

PURPOSE: To evaluate the long-term results of spironolactone in non-resolving central serous chorio-retinopathy (CSCR) and recurrence rates of CSCR. METHODS: Interventional uncontrolled open-label prospective clinical trial of patients with non-resolving CSCR who were treated with spironolactone 50 mg daily (Spironolacton AL® 50 mg, ALIUD PHARMA) for up to 16 weeks. Follow-up visits were performed at 3, 6, 9, and 12 months. Retreatment criteria for recurrence were: gain in sub-retinal fluid (SRF) of more than 25 % plus/or increase of central retinal thickness (CRT) of more than 50 µm plus visual symptoms compared to last visit. MAIN OUTCOME MEASURES: 12-month efficacy of upload treatment with spironolactone. Secondary outcome measure was the recurrence rate at 6, 9, and 12 months. RESULTS: Of the 21 study eyes treated, 71 % (n = 15) showed significant improvement or complete regression on OCT examination over 12 months. Nineteen percent of the patients (n = 4) showed a stable course from visit 1 to visit 12. The overall reduction of sub-retinal fluid from visit 1 (156 µm ± 131 SD) to visit 12 (53 µm ± 93 SD) was statistically significant (p = 0.003). The change of mean visual acuity (log MAR) from 0.25 (± 0.17 SD) at baseline to 0.17 (± 0.18 SD) at visit 12 was statistically significant, with p = 0.044. CONCLUSION: Our results confirm a positive effect of spironolactone in non-resolving CSCR in 71 % of cases. Evaluation of recurrence rates and retreatments showed good results in patients who responded to spironolactone primarily. A prospective randomized trial may provide better data about this non-invasive treatment.

Evaluation of a short-term topical interferon α-2b treatment for histologically proven melanoma and primary acquired melanosis with atypia.

OBJECTIVE: To evaluate the efficiency of series of 6-week treatments with brief intervals (6-week = 1 cycle) of topical Interferon α-2b (IFNα-2b) treatment in primary acquired melanosis (PAM) with atypia and melanoma of the conjunctiva. PATIENTS AND METHODS: Five patients with biopsy-proven PAM with atypia and seven patients with melanoma of the conjunctiva, treated with topical IFNα-2b (1 million units/ml, 5 times daily), were included in the study. All patients had colour photographs and the tumour area was measured manually for each patient before and after treatment. RESULTS: The median age of 12 patients at initiation of treatment was 61.5 years (range 39-75 years). The mean therapy duration was 2.4 cycles (range 1-6 cycle). Compared to pretreatment lesion dimension, the mean decrease in tumour size were after the first cycle 66% (range 18-98%; p = 0.004; n = 10 patients), after the second cycle 55% (range 10-100%; p = 0.016; n = 7 patients), and after the third cycle 74% (range 23-100%; n = 3 patients). In one patient 6 cycles of topical IFNα-2b were needed. The decrease in size was 22% after the 4(th) cycle, 34% after the 5(th) cycle, and 98% after the 6(th) cycle. CONCLUSION: Our clinical experience demonstrates promising results of topical IFNα-2b treatment for PAM with atypia and melanoma of the conjunctiva without any local or systemic side effects. However, future multicenter prospective studies are recommended to confirm the efficiency and safety of topical IFNα-2b treatment.

Scleral Thickness as a Risk Factor for Central Serous Chorioretinopathy and Pachychoroid Neovasculopathy.

In the pathophysiology of central serous chorioretinopathy (CSC), scleral changes inducing increased venous outflow resistance are hypothesized to be involved. This work aims to investigate anterior scleral thickness (AST) as a risk factor for pachychoroid disorders. A randomized prospective case-control study was performed at the Ludwig Maximilians University, Department of Ophthalmology. In patients with CSC or pachychoroid neovasculopathy (PNV) and in an age- and refraction-matched control group, swept source optical coherence tomography (SS-OCT) was used to measure anterior scleral thickness (AST). Subfoveal choroidal thickness (SFCT) was assessed using enhanced depth imaging OCT (EDI-OCT). In total, 46 eyes of 46 patients were included in this study, with 23 eyes in the CSC/PNV and 23 eyes in the control group. A significantly higher AST was found in the CSC/PNV compared with the control group (403.5 ± 68.6 (278 to 619) vs. 362.5 ± 62.6 (218 to 498) µm; p = 0.028). Moreover, the CSC/PNV group showed a higher SFCT (392.8 ± 92.8 (191-523) vs. 330.95 ± 116.5 (167-609) µm, p = 0.004). Compared with the age- and refraction-matched controls, patients with CSC and PNV showed a significantly thicker anterior sclera. Scleral thickness might contribute to the venous overload hypothesized to induce pachychoroid phenotypes.

Optimal Patient Adherence and Long-Term Treatment Outcomes of Neovascular Age-Related Macular Degeneration in Real-Life.

PURPOSE: To report on long-term real-life outcomes of anti-vascular endothelial growth factor (anti-VEGF) therapy in neovascular age-related macular degeneration (nAMD) with optimal patient adherence. METHODS: For this retrospective monocenter study, we identified 3217 eyes of 2793 patients that received a minimum of three intravitreal anti-VEGF injections for nAMD therapy between 2006 and 2014 at the University Eye Hospital Munich. From those, we included eyes with treatment-naïve nAMD, follow-up (FU) of ≥60 months and continuous adherence during FU. Primary measures were corrected visual acuity (VA), number of injections and visits as well as treatment regimen. RESULTS: We included 161 eyes of 125 patients with a mean FU of 8.0 ± 2.3 years. Mean VA at baseline was 60.1 letters (Snellen equivalent, 20/63). After the third year, mean VA declined constantly by 2-3 letters per year. After 5 and 8 years, 26.1% and 42.1% had lost at least 3 lines from baseline. Mean cumulative number of injections was 5.3 after the first year, and 23.9, 38.1, 48.5 after 5, 8, and 10 years. "Treat and extent" regimen with higher injection frequency correlated with better function. At time of last FU, 69.8% of eyes were under active treatment. Eyes with ≥70 letters at baseline correlated with better VA at the end of FU. CONCLUSIONS: Despite optimal patient adherence, visual function declined progressively in real-life nAMD therapy over long-term. The highest impact on treatment success is given by an early treatment start with individual but intensive anti-VEGF therapy.

[Retinal imaging of vitreomacular traction diseases]. / Retinale Bildgebung bei traktiven vitreomakulären Erkrankungen.

Advances in imaging techniques of the retina have substantially enhanced our current understanding of the pathogenesis, morphology and prognosis of vitreomacular retinal diseases. Optical coherence tomography-based criteria and classification systems were recently proposed for uniform diagnoses and treatment recommendations for patients with vitreomacular traction, epiretinal gliosis and the various forms of macular holes. This article provides an overview of the different retinal imaging modalities as well as the currently recommended classification for vitreomacular traction pathologies.

Pachychoroid disease and its association with retinal vein occlusion: a case-control study.

The development of a retinal vein occlusion (RVO) is multifactorial. This study investigates pachychoroid as a risk factor for RVO or as an entity sharing common pathophysiology with RVO. A database screening at the University Eye Hospital, Ludwig-Maximilian University Munich, Germany was performed for patients diagnosed with central or branch RVO (CRVO/BRVO). In every patient a complete ophthalmologic examination was performed, including posterior segment enhanced depth spectral domain optical coherence tomography (EDI-SD-OCT). The SD-OCT scans of respective partner eyes without history of RVO were compared to an age- and refraction-matched, randomly recruited normal control group. In total, 312 eyes of 312 patients were included in this study, with 162 eyes in the RVO and 150 eyes in the control group. A significantly higher subfoveal choroidal thickness (SFCT) was found in the RVO (310.3 ± 72.5 (94 to 583) µm) as compared to the control group (237.0 ± 99.0 (62 to 498); p < 0.00001). Moreover, the RVO group showed a significantly higher prevalence of a symptomatic pachychoroid (22 vs. 9 eyes; odds ratio: 2.46; 95 CI: 1.10 to 5.53; p = 0.029). Since pachychoroid disease represents a bilateral entity, it might be a risk factor for RVO, or share risk factors with RVO.

Interferon alpha for the treatment of melanocytic conjunctival lesions.

BACKGROUND: To evaluate the effect of topical interferon alpha-2b therapy in the treatment of melanocytic conjunctival lesions. DESIGN: Non-comparative prospective case series. METHODS: Nine patients with histologically proven acquired melanosis with atypia and/or conjunctival melanoma were treated with recombinant IFN alpha-2b (Intron A, Essex Pharma, Luzern, Switzerland). The agent was diluted under sterile conditions to one million international units per ml Intron A and packed in single-dose units (EDO) by the pharmacy. It was stored in the refrigerator and applied 5 x 1 drop/day topically by the patient for 6 weeks. The patients were seen after 2 weeks and after the end of the treatment. Endpoint of the treatment was the complete regression of pigmentation or absence of cytological atypia in a re-biopsy. RESULTS: Seven lesions of nine patients showed regression and lost pigmentation. Three patients required a second cycle after the first therapy because of incomplete regression and one patient needed a third cycle of interferon. Only one of the patients needed a fourth cycle of therapy and additional surgery to show stable regression. The follow-up is 24.8 months (median). No local or systemic side-effects were encountered. The pre- and post-treatment photos of two cases will be presented. CONCLUSIONS: Our observations suggest that topical interferon alpha-2b might be an effective agent for the adjuvant treatment of melanocytic conjunctival tumors without side-effects. It might be an alternative to other more toxic chemotherapeutical agents. A prospective multicenter study will help to finally evaluate the potential of topical interferon therapy for melanocytic conjunctival tumors, in particular PAM with atypia and minimal invasive conjunctival melanoma.

Scleral Fixation of the Fluocinolone Acetonide Implant in Eyes with Severe Iris-Lens Diaphragm Disruption and Recalcitrant CME: The Fluocinolone-Loop-Anchoring Technique (FLAT).

INTRODUCTION: While proven to be an effective treatment for cystoid macular edema (CME) and diabetic macular edema, intravitreal steroid implants (IVSI) may cause undesirable side effects, including steroid-related glaucoma or migration into the anterior chamber in the case of iris-lens diaphragm disruption. Here we present a new surgical technique that allows for the easy implantation and subsequent fixation of the fluocinolone acetonide intravitreal implant without the risk of migration as a feasible and possibly reversible approach in the treatment of persistent CME in severely damaged eyes. METHODS: In this single-center, prospective off-label, proof of principle, scleral fixation of the fluocinolone implant was performed in two eyes with disrupted anterior-posterior segment border and persistent CME. Both eyes were then followed monthly in accordance to a detailed protocol. RESULTS: The procedure was overall well tolerated without severe side effects. There was no migration of the implant in the anterior chamber in either eye. CONCLUSION: Scleral fixation of the fluocinolone implant proved to be a safe and feasible approach in eyes with persistent CME and disrupted anterior-posterior segment border. This new technique also allows for the possible removal of the implant and may therefore be suitable even for eyes at higher risk for side effects, such as glaucoma.

Two Year Visual Acuity and Structural Outcomes in Patients with Diabetic Macular Oedema Treated with Intravitreal Aflibercept - A Retrospective Cohort Study.

PURPOSE: To assess visual and anatomical outcomes of intravitreal aflibercept for clinically significant diabetic macular oedema (DME). METHODS: For this retrospective single-center cohort study at a tertiary referral center, we performed a data warehouse query to identify 117 treatment-naive patients (139 eyes) undergoing intravitreal treatment with aflibercept for DME between January 2014 and May 2018. Changes in best-corrected visual acuity (BCVA) values (as measured with ETDRS letters), central retinal thickness (CRT) and total macular volume (TVOL) are reported over a two-year period at various time-points. RESULTS: The total number of injections per study eye was 5.5 ± 1.4 after one and 8.7 ± 2.2 injections after two years. Baseline visual acuity (VA) was 60.1 ± 14.5 letters. A gain of 4.8 and 9.2 letters from baseline was observed after one and two years, respectively (both p ≤ 0.01). In comparison to the mean CRT at baseline (419 ± 174 µm), a CRT decrease was observed after one and two years of treatment (298 ± 115 µm and 319 ± 119 µm, respectively; both p ≤ 0.01). Similarly, TVOL decreased from 10.12 ± 2.05 mm3 to 8.96 ± 0.96 mm3 and 9.01 ± 1.29 mm3 (both p ≤ 0.01). CONCLUSION: This study demonstrates that treating DME with intravitreal aflibercept yields positive functional and structural outcomes over a two-year period. However, we observed fewer injection numbers, along with inferior VA and structural outcomes than has been reported in randomized clinical trials. Our results show similar results as in patients treated with ranibizumab due to DME in real-life settings.

Evaluation of Functional Outcomes and OCT-Biomarkers after Intravitreal Dexamethasone Implant for Postoperative Cystoid Macular Edema in Vitrectomized Eyes.

PURPOSE: To evaluate the efficacy of dexamethasone implant (DEX) for the treatment of postoperative cystoid macular edema (PCME) in vitrectomized eyes and to investigate visual and morphological OCT predictive factors. METHODS: In this retrospective study, eyes with PCME after vitrectomy were treated with at least one DEX injection and were observed over 12 months. Indications for surgery were epiretinal membrane (ERM) or rhegmatogenous retinal detachment (RRD) without macular involvement. Prior treatments, if any, were noted. Best corrected visual acuity (BCVA), central foveal thickness (CFT), and OCT morphology including the presence of intraretinal cysts/fluid or subretinal fluid (IRF/SRF) and ellipsoid zone (EZ) continuity were evaluated. Correlations between OCT measures and visual outcomes were analyzed by the generalized estimating equations procedure. RESULTS: Forty-six eyes with ERM and 15 eyes with RRD were enrolled. The ERM group was more likely to gain BCVA than RRD (odds ratio (OR), 1.168; 95% confidence interval (CI), 1.003-1.360; p=0.046). The absence of SRF (OR, 0.860; 95% CI, 0.743-0.995; p=0.043) was predictive of worse BCVA, whereas the integrity of EZ (OR, 1.094; 95% CI, 0.951-1.257; p=0.209) or naïve status (OR, 0.946; 95% CI, 0.871-1.137, p=0.853) was not. Eyes with a worse baseline BCVA were more likely to gain >1 line after 12 months (OR, 1.485; 95% CI, 1.171-1.884; p=0.001). CONCLUSION: The efficacy of the treatment of PCME in vitrectomized eyes seems to be affected by baseline BCVA, the absence of SRF, and the indication for surgery. Naïve status appears not to play any significant role in the prediction of BCVA. This trial is registered with DRKS00018955.

Ranibizumab non-response in pachychoroid neovasculopathy: Effects of switching to aflibercept.

Non-response to intravitreal ranibizumab represents a frequent problem in pachychoroid neovasculopathy (PNV). To investigate the effectivity of switching to aflibercept, the database of the Ludwig Maximilians University, Munich, was screened for patients fulfilling the following inclusion criteria: (i) diagnosis of PNV; (ii) inadequate response to ≥ 3 ranibizumab injections, in spite of monthly dosing, defined as persistence of subretinal-fluid four weeks after the last ranibizumab injection; (iii) resulting switch to aflibercept administered as three monthly injections. Primary outcome measure was percentage of eyes with a dry macula four weeks after the third aflibercept injection. Secondary outcome measures included changes in maximum subretinal fluid (SRF), central subfield thickness (CST) and subfoveal choroidal thickness (SFCT). In total, 14 eyes of 14 patients were included. Mean age was 64.1 ± 7.5 (range: 51-78) years. Switching to aflibercept was performed after mean 8.4 ± 4.1 (3-15) ranibizumab injections. While no eye (0%) achieved a dry macula status during ranibizumab treatment, switching to aflibercept achieved a dry macula status in eight eyes (57.1%) after three injections. While both ranibizumab and aflibercept showed an effect on CST (p = 0.027, p = 0.003), only aflibercept showed a significant effect on SRF (p = 0.0009) and SFCT (p = 0.044). In cases of PNV not responding to intravitreal ranibizumab, switching treatment to aflibercept induces a favorable short-term response resolving persistent fluid and achieving a dry macula. Further studies with longer follow-up are warranted.

Gender-related differences in patients treated with intravitreal anti-vascular endothelial growth factor medication for diabetic macular oedema.

BACKGROUND: Diabetes prevalence is constantly rising, involving the eyes with damage including development of diabetic macular oedema. Since 2012, intravitreal anti-vascular endothelial growth factor medication is available for diabetic macular oedema treatment. Endocrinological studies have shown that fewer women are affected by diabetes. However, when affected, they exhibit more severe diabetic complications than men. We have investigated gender-related differences in diabetic macular oedema and outcome in an ophthalmological tertiary referral hospital. METHODS: We included 88 patients (54 males and 34 females) with 112 eyes (68 male and 44 female) having clinically significant diabetic macular oedema, treated with anti-vascular endothelial growth factor medication. A 1 year follow-up was performed in all patients (visual acuity and optical coherence tomography). Previous retinal surgery was an exclusion criterion, as were other retinal pathologies. RESULTS: The mean visual acuity and mean central retinal thickness at baseline were 0.53 logMAR (male 0.49 and female 0.595) and 469 µm (male 452 µm and female: 494 µm), respectively. After 360 days, mean visual acuity changed by -0.07 (±0.36) logMAR (male -0.11 and female +0.01) and mean central retinal thickness changed by -119 µm (male -113 µm and female -127 µm). For visual acuity, a significant difference was noted at baseline (p = 0.02) and at 1 year (p < 0.001). Males received 5.6 injections and females received 5.68 injections in 1 year. CONCLUSION: Our study showed that female patients with diabetic macular oedema were diagnosed with and treated for diabetic macular oedema at a stage when visual acuity and optical coherence tomography were worse than those in their male counterparts. This gender difference could not be reduced, despite similar numbers of injections. Female diabetic patients should therefore be assessed early for ophthalmological pathologies.

Utility values in patients with acquired anophthalmus.

BACKGROUND: Loss of an eye can be supposed to lead to reduced health-related quality of life. This can be due to monophthalmia in acquired anophthalmus and/or because of cosmetic impairment. Meanwhile several methods exist to evaluate the quality of life and the impairment in utility values in patients with ophthalmological diseases. METHODS: Twenty-three patients who underwent enucleation of one eye with good visual acuity of the fellow eye (>20/30) were included. All patients were asked to complete a standardized time trade-off (TTO) utility assessment form as well as the self-administered National Eye Institute Visual Function Questionnaire 25 (VFQ 25). TTO was assessed for restoring vision (TTO-A) and for restoring cosmetic appearance (TTO-B). RESULTS: The mean TTO value for visual function (TTO-A) was 0.87, the mean TTO value for cosmetic restoration (TTO-B) was 0.90 with a significant correlation. These values are surprisingly high compared to current TTO data. Visual acuity of the last eye and utility values were not correlated. TTO was not influenced by the underlying diagnosis. Patients older than 50 years were willing to trade off relatively more years than younger patients. TTO values were independent from the duration of the acquired anophthalmus. The mean VFQ-25 composite score was 81.0 and significantly lower than in the normal population. There was no significant correlation between TTO and the VFQ-25 composite score or any of the 12 subscales of the VFQ-25. CONCLUSION: Utility of patients with acquired anophthalmus and good vision of the last eye is very similar to patients with two eyes of which one is worse and good binocular vision. The VFQ-25 is no predictor for time trade-off.

3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients.

PURPOSE: The prospective, comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema has shown advantage of a combination therapy compared to ranibizumab monotherapy at year 1 with significantly reduced injections. The purpose of this retrospective study was to determine the long-term visual gains and need of injections in a 3 year-follow-up period. METHODS: Retrospective analysis of patients of the original study in the long-term follow-up from month 12 to 36. BCVA measurements following the original 1 year study were taken using logMAR charts. Injections were provided with standard of care using PRN, based on change in BCVA and CRT using SD-OCT scans. Main outcome measures were change in BCVA and mean number of injections from 12 to 36 months. RESULTS: BCVA was stable in both groups from 12 through 36 months, showing a change of 0.16 ± 0.1 log MAR. Following the initial reduction in required injections at month 12, combination therapy patients continued to require 1.3 times fewer injections over the next 24 months (2.91 ± 2.3 vs 3.85±3.7 injections for monotherapy). CONCLUSIONS: Combination of navigated laser and ranibizumab achieved BCVA gains equivalent to anti-VEGF monotherapy. These results could be maintained through month 36. Required injections were 2.0 injections lower in year 1 and further 1.3 times fewer in year 2 and 3 in the combination group compared to monotherapy. Adding navigated laser photocoagulation to intravitreal anti-VEGF therapy may still represent a superior therapeutic approach to DME patients.