High-addition segmented refractive bifocal intraocular lens in inactive age-related macular degeneration: A multicenter pilot study

This multicenter, open-label study aimed to determine the safety and functional outcome of a high-addition segmented refractive bifocal intraocular lens (IOL) in late inactive age-related macular degeneration (AMD). Twenty eyes of 20 patients were enrolled and followed until 12 months after the intervention. Patients underwent cataract surgery with implantation of a LS-313 MF80 segmented refractive bifocal intraocular lens with a near addition of +8.0 D (Teleon Surgical Vertriebs GmbH, Berlin, Germany). The main outcome measures were distance corrected near visual acuity (DCNVA) and safety as determined by intra- and post-operative complications. Secondary outcomes included distance corrected visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), the need for magnification to read newspaper, preferred reading distance, speed and performance (logRAD), as well as patient satisfaction. Mean DCNVA improved from 0.95 (±0.19) to 0.74 (±0.35) logMAR, until 6 months after surgery, P<0.05. CDVA improved from 0.70 (±0.23) to 0.59 (±0.30) logMAR, UDVA from 0.94 (±0.25) to 0.69 (±0.34) logMAR, UNVA from 1.08 (±0.19) to 0.87 (±0.43) logMAR. The mean need for magnification decreased from 2.9- to 2.3-fold, preferred reading distance from 23 to 20 cm. No intraoperative complications occurred during any of the surgeries. One patient lost > 2 lines of CDVA between 6 and 12 months, in another case, the study IOL was exchanged for a monofocal one due to dysphotopsia and decreased CDVA. Implantation of a segmented refractive bifocal IOL with +8.0 D addition improves near and distance vision in patients with late AMD and has a satisfactory safety profile.

Download Full-text

Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-313907 ◽

2019 ◽

Vol 104 (1) ◽

pp. 64-73

Author(s):

Francesco Bandello ◽

Giovanni Staurenghi ◽

Federico Ricci ◽

Edoardo Midena ◽

Francesco Viola ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Open Label ◽

Age Related ◽

Risk Period ◽

The Mean ◽

Low Incidence ◽

To Receive ◽

Systemic Drug

BackgroundTo evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.MethodsIn this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.ResultsOf the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.ConclusionsThe low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.

Download Full-text

A Longitudinal Follow-Up Study of Saffron Supplementation in Early Age-Related Macular Degeneration: Sustained Benefits to Central Retinal Function

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/429124 ◽

2012 ◽

Vol 2012 ◽

pp. 1-9 ◽

Cited By ~ 34

Author(s):

M. Piccardi ◽

D. Marangoni ◽

A. M. Minnella ◽

M. C. Savastano ◽

P. Valentini ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Early Age ◽

Open Label ◽

Macular Function ◽

Age Related ◽

Baseline Values ◽

Reciprocal Value

Objectives. In a previous randomized clinical trial (Falsini et al. (2010)), it was shown that short-term Saffron supplementation improves retinal flicker sensitivity in early age-related macular degeneration (AMD). The aim of this study was to evaluate whether the observed functional benefits from Saffron supplementation may extend over a longer follow-up duration.Design. Longitudinal, interventional open-label study.Setting. Outpatient ophthalmology setting.Participants. Twenty-nine early AMD patients (age range: 55–85 years) with a baseline visual acuity >0.3.Intervention. Saffron oral supplementation (20 mg/day) over an average period of treatment of 14 (±2) months.Measurements. Clinical examination and focal-electroretinogram-(fERG-) derived macular (18°) flicker sensitivity estimate (Falsini et al. (2010)) every three months over a followup of 14 (±2) months. Retinal sensitivity, the reciprocal value of the estimated fERG amplitude threshold, was the main outcome measure.Results. After three months of supplementation, mean fERG sensitivity improved by 0.3 log units compared to baseline values (P<0.01), and mean visual acuity improved by two Snellen lines compared to baseline values (0.75 to 0.9,P<0.01). These changes remained stable over the follow-up period.Conclusion. These results indicate that in early AMD Saffron supplementation induces macular function improvements from baseline that are extended over a long-term followup.

Download Full-text

The efficacy of “IOL-Vip Revolution” telescopic intraocular lens in age-related macular degeneration cases with senile cataract

European Journal of Ophthalmology ◽

10.1177/1120672118803831 ◽

2018 ◽

Vol 29 (6) ◽

pp. 615-620

Author(s):

Medine Yilmaz Dag ◽

Filiz Afrashi ◽

Serhad Nalcaci ◽

Jale Mentes ◽

Cezmi Akkin

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Intraocular Lens ◽

Corneal Thickness ◽

Anterior Chamber Depth ◽

Age Related Macular Degeneration ◽

Corrected Visual Acuity ◽

Age Related ◽

Best Corrected Visual Acuity

Purpose: To evaluate the efficacy of the IOL-Vip Revolution telescopic intraocular lens in age-related macular degeneration patients. Methods: A total of 13 eyes of 12 age-related macular degeneration patients with senile cataract were enrolled. Selection of the patients was done by means of a low vision diagnostic and rehabilitative program (IOL-Vip software) that evaluates residual visual function. After standard phacoemulsification surgery, the incision site was enlarged and the IOL-Vip Revolution system was implanted in the capsular bag. The outcome measures were best corrected visual acuity, contrast sensitivity, anterior chamber depth, endothelial cell density, central corneal thickness, and quality-of-life questionnaire. Results: The mean age of the subjects was 72.3 ± 8.5 years. The mean positive power of the intraocular lens was 59 ± 2 D and the negative intraocular lens power was standard (–46 D). Pre- and postoperative best corrected visual acuity were 1.08 ± 0.14 and 0.81 ± 0.16 logMAR in the operated eye and 1.13 ± 0.36 and 1.01 ± 0.40 logMAR in the unoperated eye, respectively. The best corrected visual acuity was increased significantly in both operated and unoperated eyes (p = 0.005 and 0.021, respectively). Quality of life and anterior chamber depth increased significantly (p = 0.018 and 0.008, respectively), while endothelial cell density decreased (p = 0.002). No significant differences were detected in central corneal thickness or contrast sensitivity (p = 0.133 and 0.684, respectively). Conclusion: The results showed that IOL-Vip Revolution telescopic intraocular lens is a promising treatment option in age-related macular degeneration patients. The rehabilitation program may have an important role in the restored clinical results, which also provided visual improvement in the unoperated eyes.

Download Full-text

Implantation of Scharioth macula lens in patients with age-related macular degeneration: results of a prospective European multicentre clinical trial

BMJ Open Ophthalmology ◽

10.1136/bmjophth-2019-000322 ◽

2019 ◽

Vol 4 (1) ◽

pp. e000322 ◽

Cited By ~ 1

Author(s):

Sathish Srinivasan ◽

Gabor Scharioth ◽

Anneliese Riehl ◽

Ivan V Tanev ◽

Pavel Rozsival ◽

...

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Macular Degeneration ◽

Intraoperative Complications ◽

Age Related Macular Degeneration ◽

Inclusion Criteria ◽

Multicentre Clinical Trial ◽

Refractive Outcomes ◽

Age Related ◽

The Mean

ObjectiveTo report the visual and refractive outcomes following monocular implantation of a supplementary (piggyback) Scharioth macula lens (SML) in previously pseudophakic eyes with age-related macular degeneration (AMD).Methods and analysisProspective European multicentre clinical trial. 50 eyes of 50 pseudophakic patients with either dry or previously treated and stable neovascular AMD for at least 6 months were included. The inclusion criteria were age over 55, corrected distance visual acuity (CDVA) of 0.4–0.1 (decimal), improvement of at least three lines of corrected near visual acuity (CNVA) when tested with a +6.0 dioptre (D) reading addition at 15 cm, compared with a +2.5 D reading addition at 40 cm using a standardised, self-illuminated Early Treatment Diabetic Retinopathy Study near vision chart. The SML intraocular lens (IOL) was implanted as an add-on/piggyback IOL in the ciliary sulcus, monocularly in the better seeing eye of each subject meeting the inclusion criteria.ResultsThere were no intraoperative complications. One subject had the SML explanted in the postoperative period due to postoperative glare/halos. The mean CNVA improved from 0.23±0.12 (decimal) preoperatively to 0.57±0.33 at 1 year. The mean CDVA remained unchanged measuring 0.19±0.13 preoperatively and 0.19±0.09 at 1 year postoperatively.ConclusionThe SML appears to be safe and effective in improving the CNVA in patients with AMD. Data suggest that the CDVA remains unaffected following implantation. Further data are needed to assess the long-term safety and efficacy.

Download Full-text

Changes in visual acuity in patients with dry form of age-related macular degeneration after low-energy light therapy and medication

Oftalmologicheskii Zhurnal ◽

10.31288/oftalmolzh201652228 ◽

2016 ◽

Vol 63 (5) ◽

pp. 22-28

Author(s):

A. Sergienko ◽

◽

N. Dzyuba ◽

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Light Therapy ◽

Low Energy ◽

Age Related Macular Degeneration ◽

Age Related

Download Full-text

Genetic biomarkers in the VEGF pathway predicting response to anti-VEGF therapy in age-related macular degeneration

BMJ Open Ophthalmology ◽

10.1136/bmjophth-2019-000273 ◽

2019 ◽

Vol 4 (1) ◽

pp. e000273

Author(s):

Irina Balikova ◽

Laurence Postelmans ◽

Brigitte Pasteels ◽

Pascale Coquelet ◽

Janet Catherine ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Treatment Response ◽

Multiple Testing ◽

Age Related Macular Degeneration ◽

Patient Specific ◽

Multiple Testing Correction ◽

Anti Vegf ◽

Age Related ◽

Vegf Pathway

ObjectiveAge-related macular degeneration (ARMD) is a leading cause of visual impairment. Intravitreal injections of anti-vascular endothelial growth factor (VEGF) are the standard treatment for wet ARMD. There is however, variability in patient responses, suggesting patient-specific factors influencing drug efficacy. We tested whether single nucleotide polymorphisms (SNPs) in genes encoding VEGF pathway members contribute to therapy response.Methods and analysisA retrospective cohort of 281 European wet ARMD patients treated with anti-VEGF was genotyped for 138 tagging SNPs in the VEGF pathway. Per patient, we collected best corrected visual acuity at baseline, after three loading injections and at 12 months. We also registered the injection number and changes in retinal morphology after three loading injections (central foveal thickness (CFT), intraretinal cysts and serous neuroepithelium detachment). Changes in CFT after 3 months were our primary outcome measure. Association of SNPs to response was assessed by binomial logistic regression. Replication was attempted by associating visual acuity changes to genotypes in an independent Japanese cohort.ResultsAssociation with treatment response was detected for seven SNPs, including in FLT4 (rs55667289: OR=0.746, 95% CI 0.63 to 0.88, p=0.0005) and KDR (rs7691507: OR=1.056, 95% CI 1.02 to 1.10, p=0.005; and rs2305945: OR=0.963, 95% CI 0.93 to 1.00, p=0.0472). Only association with rs55667289 in FLT4 survived multiple testing correction. This SNP was unavailable for testing in the replication cohort. Of six SNPs tested for replication, one was significant although not after multiple testing correction.ConclusionIdentifying genetic variants that define treatment response can help to develop individualised therapeutic approaches for wet ARMD patients and may point towards new targets in non-responders.

Download Full-text

Association between retinal thickness variation and visual acuity change in neovascular age‐related macular degeneration

Clinical and Experimental Ophthalmology ◽

10.1111/ceo.13927 ◽

2021 ◽

Author(s):

Kai Xiong Cheong ◽

Alvin Wei Jun Teo ◽

Chui Ming Gemmy Cheung ◽

Issac Horng Khit Too ◽

Usha Chakravarthy ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Retinal Thickness ◽

Age Related Macular Degeneration ◽

Thickness Variation ◽

Age Related

Download Full-text

Vision before and after scharioth macular lens implantation in patients with AMD: an electrophysiological study

Documenta Ophthalmologica ◽

10.1007/s10633-020-09814-8 ◽

2021 ◽

Author(s):

Jan Kremláček ◽

Jana Nekolová ◽

Markéta Středová ◽

Jana Langrová ◽

Jana Szanyi ◽

...

Keyword(s):

Visual Acuity ◽

Peripheral Vision ◽

Electrophysiological Study ◽

Age Related Macular Degeneration ◽

Peak Time ◽

Pattern Reversal ◽

Motion Onset ◽

Age Related ◽

Lens Implantation ◽

Near Visual Acuity

Abstract Background For patients with age-related macular degeneration (AMD), a special intraocular lens implantation partially compensates for the loss in the central part of the visual field. For six months, we evaluated changes in neurophysiological parameters in patients implanted with a “Scharioth macula lens” (SML; a center near high add + 10 D and peripheral plano carrier bifocal lens designed to be located between the iris and an artificial lens). Methods Fourteen patients (5 M, 9 F, 63–87 years) with dry AMD were examined prior to and at 3 days after, as well as 1, 2, and 6 months after, implantation using pattern-reversal, motion-onset, and cognitive evoked potentials, psychophysical tests evaluating distant and near visual acuity, and contrast sensitivity. Results Near visual acuity without an external aid was significantly better six months after implantation than before implantation (Jaeger table median (lower; upper quartile): 4 (1; 6) vs. 15 (13; 17)). Distant visual acuity was significantly altered between the pre- (0.7 (0.5; 0.8) logMAR) and last postimplantation visits (0.8 (0.7; 0.8) logMAR), which matched prolongation of the P100 peak time (147 (135; 151) ms vs. 161 (141; 166) ms) of 15 arc min pattern-reversal VEPs and N2 peak time (191.5 (186.5; 214.5) ms vs. 205 (187; 218) ms) of peripheral motion-onset VEPs. Conclusion SML implantation significantly improved near vision. We also observed a slight but significant decrease in distant and peripheral vision. The most efficient electrophysiological approach to test patients with SML was the peripheral motion-onset stimulation, which evoked repeatable and readable VEPs.

Download Full-text