Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen—An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula

Purpose: To compare the changes in visual and ocular parameters in individuals with retinal drusen who were treated with two commercially available nutritional supplements. Methods: An open-label, single-center, randomized, parallel-treatment with an observational control group design was utilized. The treatment groups included individuals with fine retinal drusen sub-clinical age-related macular degeneration (AMD), while the control group consisted of ocular normal individuals. The treatment groups were randomly assigned to the micronized lipid-based carotenoid supplement, Lumega-Z (LM), or the PreserVision Age-Related Eye Disease Study 2 (AREDS-2) soft gel (PV). Visual performance was evaluated using the techniques of visual acuity, dark adaptation recovery and contrast sensitivity, at baseline, three months, and six months. Additionally, the macular pigment optical density (MPOD) was measured. The control group was not assigned any carotenoid supplement. The right eye and left eye results were analyzed separately. Results: Seventy-nine participants were recruited for this study, of which 68 qualified and 56 participants had useable reliable data. Of the individuals who completed this study, 25 participants belonged to the LM group, 16 belonged to the PV group, and 15 to the control group. The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months (p < 0.001). The LM group displayed a positive linear trend with treatment time in CSF (p < 0.001), with benefits visible after just three months of supplementation. Although there was a trend showing improvement in CSF in the PV group, the change was not significant after a Bonferroni-corrected p-value of p < 0.00625. Visual acuity, dark adaptation recovery and MPOD did not significantly improve in either treatment groups. Conclusion: The LM group demonstrated greater and faster benefits in visual performance as measured by CSF when compared to the PV group. This trial has been registered at clinicaltrials.gov (NCT03946085).

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Supplementation with three macular carotenoids in patients with early stage age-related macular degeneration

Medicinski pregled ◽

10.2298/mpns1910291j ◽

2019 ◽

Vol 72 (9-10) ◽

pp. 291-296

Author(s):

Sandra Jovanovic ◽

Sofija Davidovic ◽

Aleksandar Miljkovic ◽

Milica Atanackovic-Krstonosic ◽

Darija Sazdanic ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Contrast Sensitivity ◽

Early Stage ◽

Visual Quality ◽

Age Related Macular Degeneration ◽

Visual Performance ◽

Early Age ◽

Age Related ◽

Glare Sensitivity

Introduction. Macula lutea is the central part of the retina and it houses carotenoid macular pigments - lutein, zeaxanthin, and meso-zeaxanthin. It is considered that carotenoids can prevent or slow down the progression of the early age-related macular degeneration in some patients. Therefore, the aim of this study was to examine the effects of supplementation with all three macular pigments on vision quality in patients with early agerelated macular degeneration. Material and Methods. This prospective study included 15 patients (25 eyes in total) with early age-related macular degeneration. All visual tests - visual acuity, glare sensation and contrast sensitivity, were performed at baseline and after 6 months of continuous supplementation with 10 mg lutein, 2 mg zeaxanthin, and 10 mg mesozeaxanthin. Results. The results showed that glare sensitivity improved in 20% of cases. Most of the examined eyes (76%) presented without visual acuity deterioration. Similar results were obtained for the contrast sensitivity test, where in 80% of cases vision quality remained stable or improved. There were no statistically significant differences between average values of examined parameters at baseline and after 6 months of supplementation. Conclusion. In most of the examined eyes (over 75%) visual quality remained stable or improvement of measured parameters was observed. This type of supplementation may improve visual performance or its preservation in patients with early age-related macular degeneration.

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The impact of saffron (Crocus sativus) supplementation on visual function in patients with dry age-related macular degeneration

Italian Journal of Medicine ◽

10.4081/itjm.2016.758 ◽

2016 ◽

Vol 10 ◽

Cited By ~ 5

Author(s):

Abbas Riazi ◽

Yunes Panahi ◽

Ali Agha Alishiri ◽

Mohammad Ahmad Hosseini ◽

Ali Akbar Karimi Zarchi ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Contrast Sensitivity ◽

Visual Function ◽

Low Vision ◽

Age Related Macular Degeneration ◽

Crocus Sativus ◽

Control Group ◽

Age Related ◽

The Impact

The aim was to evaluate the impact of saffron supplementation on visual function in patients with dry age-related macular degeneration (ARMD). Fifty-four participants, 23 male and 31 female, with dry ARMD were assigned to one of the following two groups. The treatment group (n=29) consumed 50 mg saffron daily during a 3- month period, while 25 subjects served as the control group. Visual acuity, contrast sensitivity, and retinal thickness were measured at the beginning and at the end of the study. Quality of life was evaluated using the Melbourne Low Vision Index (MLVI) before and after treatment. Significant increases in visual acuity and contrast sensitivity were found in the saffron group but not in the control group. Changes in macular thickness were not statistically different between the two groups. Short-term consumption of saffron may slow down the progression of disease and improve visual function, especially contrast sensitivity, in patients with dry ARMD.

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Lutein-Containing Antioxidants in Patients with Primary Open-Angle Glaucoma and Dry Type of Age-Related Macular Degeneration

Ophthalmology in Russia ◽

10.18008/1816-5095-2018-3-339-347 ◽

2018 ◽

Vol 15 (3) ◽

pp. 339-347 ◽

Cited By ~ 1

Author(s):

D. A. Dorofeev

Keyword(s):

Visual Acuity ◽

Contrast Sensitivity ◽

Primary Open Angle Glaucoma ◽

Open Angle Glaucoma ◽

Age Related Macular Degeneration ◽

Control Group ◽

Study Group ◽

Age Related ◽

Spatial Frequencies ◽

Spatial Contrast Sensitivity

Objective.To assess the dynamics of structural-functional markers in patients with combined pathology: primary open-angle glaucoma (POAG) and age-related macular degeneration (AMD) with the background of lutein-containing drugs at long-term follow-up.Patients and Methods.The period of research was from November 2016 to January 2018; A parallel prospective study of patients (88 eyes), mean age 67.81 ± 8.41 (M ± σ); 67.64 (63.14; 73.08) (Me, Q25%, Q75%) years with combined pathology POAG and AMD (AREDS I and II). Patients were divided into 2 groups, the first group — a study group received Retinorm, by 1 capsule 3 times a day during a meal for 1 year, a second control group of 17 patients (32 eyes) did not receive lutein-containing medicines during the observation period. The study group consisted of 29 patients (55 eyes). There were 7 males and 22 females among them. The control group consisted of 19 patients (33 eyes), 2 males and 17 females among them. Visual acuity, standard automatic computer perimetry, optical coherence tomography, determination of spatial contrast sensitivity was carried out in all patients at the beginning of the study and after 1 year.Results.The maximum correlated visual acuity (MCVA) according to the table ETDRS increased in the study group and decreased in the control group, 95% the confidence interval for the changes in the MCVA: 0.1813636; 1.018182; 1.927273 и –3.878788; –2.393939; –0.8477273 (optotypes), respectively (W = 499.5; p = 0,0002919). Statistically significant changes in the thickness of the layer of nerve fibers of the retina (RNFL) neither in the middle nor in the sectors was revealed, and the thickness of the retina in oval foveal zone by sector: upper, temporal and lower statistically significantly decreased in the control group, while remaining unchanged in the observation group (р < 0.05). Spatial contrast sensitivity (SCS) after 1 year of use Retinorm remained at the same level in the control group, while there was a statistically significant increase in spatial contrast sensitivity in the main group, especially at high spatial frequencies is observed (р < 0.05).Conclusion.The results of the study indicate a positive effect of Retinorm used for 1 year. It was reflected in the improvement visual acuity in the distance, improvement of spatial contrast sensitivity, especially at high spatial frequencies, and the preservation of structural retinal indices both in the foveal zone and peripapillary.

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Preservation of the Photoreceptor Inner/Outer Segment Junction in Dry Age-Related Macular Degeneration Treated by Rheohemapheresis

Journal of Ophthalmology ◽

10.1155/2015/359747 ◽

2015 ◽

Vol 2015 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Eva Rencová ◽

Milan Bláha ◽

Jan Studnička ◽

Vladimír Bláha ◽

Miriam Lánská ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Pigment Epithelium ◽

Retinal Pigment ◽

Treated Group ◽

Plasma Viscosity ◽

Age Related Macular Degeneration ◽

Control Group ◽

Macular Function ◽

Age Related

Aim. To evaluate the long-term effect of rheohemapheresis (RHF) treatment of age-related macular degeneration (AMD) on photoreceptor IS/OS junction status.Methods. In our study, we followed 24 patients with dry AMD and drusenoid retinal pigment epithelium detachment (DPED) for a period of more than 2.5 years. Twelve patients (22 eyes) were treated by RHF and 12 controls (18 eyes) were randomized. The treated group underwent 8 RHF standardized procedures. We evaluated best-corrected visual acuity, IS/OS junction status (SD OCT), and macular function (multifocal electroretinography) at baseline and at 2.5-year follow-up.Results. RHF caused a decrease of whole-blood viscosity/plasma viscosity at about 15/12%. BCVA of treated patients increased insignificantlyP=0.187from median 74.0 letters (56.2 to 81.3 letters) to median 79.0 letters (57.3 to 83.4 letters), but it decreased significantly from 74.0 letters (25.2 to 82.6 letters) to 72.5 letters (23.4 to 83.1 letters) in the control groupP=0.041. The mfERG responses in the region of eccentricity between 1.8° and 7° were significantly higher in treated patientsP=0.04.Conclusions. RHF contributed to sparing of photoreceptor IS/OS junction integrity in the fovea, which is assumed to be a predictive factor for preservation of visual acuity.

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

PLoS ONE ◽

10.1371/journal.pone.0256985 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0256985

Author(s):

Gerd U. Auffarth ◽

Josef Reiter ◽

Martin Leitritz ◽

Karl-Ulrich Bartz-Schmidt ◽

Fabian Höhn ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Intraocular Lens ◽

Intraoperative Complications ◽

Age Related Macular Degeneration ◽

Open Label ◽

Age Related ◽

Near Visual Acuity ◽

Reading Distance ◽

Bifocal Intraocular Lens

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.

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Blood antioxidant capacity change in patients with the «dry» form of age-related macular degeneration treated with polarized polychromatic non-coherent light and dynamic electromyostimulation

Kazan medical journal ◽

10.17816/kmj2129 ◽

2012 ◽

Vol 93 (6) ◽

pp. 994-996

Author(s):

F R Saifullina ◽

R Z Sharafieva ◽

V I Pogorel’tsev ◽

F M Fayzrahmanova ◽

E A Abdulaeva

Keyword(s):

Visual Acuity ◽

Antioxidant Capacity ◽

Macular Degeneration ◽

Combined Treatment ◽

Mean Value ◽

Main Group ◽

Age Related Macular Degeneration ◽

Control Group ◽

Coherent Light ◽

Age Related

Aim. To assess the antioxidant capacity in patients with the «dry» form of age-related macular degeneration before and after combined treatment with polarized polychromatic non-coherent light and dynamic electromyostimulation. Methods. Two groups of patients with the «dry» form of age-related macular degeneration were examined. 40 patients (80 eyes) from the main group were treated using combined treatment and 39 patients (78 eyes) in the group of control who were treated conventionally. The integral blood antioxidant capacity was measured by galvanometry. Results. Blood antioxidant capacity in healthy subjects is 26.0 kC/l. In patients of the main group blood antioxidant capacity before the treatment was equal to 22.81±0.27 kC/l, compared to 22.17±0.20 kC/l in control group (total mean value 22.49±0.27 kC/l). There was a relevant elevation of the blood antioxidant capacity at the late stages after the treatment - up to 12 months, compared to only 2 months in the control group. Visual acuity in patients of the main group before the treatment was 0.87±0.02, after the treatment was finished - 0.96±0,01 (p 0.001), 2 months after the treatment - 0.95±0.01 (p 0.001), 6 months after the treatment - 0.96±0.01 (p 0.001), 12 months after the treatment - 0.95±0.01 (p 0.001). Visual acuity in patients of the control group before the treatment was 0.91±0.02, after the treatment was finished - 0.95±0.02 (p 0.05), 2 months after the treatment - 0.94±0.02 (p 0.05), 6 months after the treatment - 0.92±0.02 (p 0.05). 12 months after the treatment the visual acuity deteriorated compared to the treatment start and was measured as 0.89±0.02. Conclusion. There is a decrease of blood antioxidant capacity (22.49±0.27 kC/l) in patients with the «dry» form of age-related macular degeneration; a relevant increase of blood antioxidant capacity and visual acuity can be observed up to 12 months after the treatment with polarized polychromatic non-coherent light and dynamic electromyostimulation.

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Correlation Between Improvement in Visual Acuity and QOL After Ranibizumab Treatment for Age-related Macular Degeneration Patients: QUATRO Study

10.21203/rs.3.rs-116089/v1 ◽

2020 ◽

Author(s):

Yuji Oshima ◽

Yumi Ishibashi ◽

Naoyasu Umeda ◽

Tatsuo Nagata ◽

Shigeo Yoshida ◽

...

Keyword(s):

Visual Acuity ◽

Patient Satisfaction ◽

Visual Function ◽

Age Related Macular Degeneration ◽

Open Label ◽

Satisfaction Questionnaire ◽

Age Related ◽

The Mean ◽

Baseline Visual Acuity ◽

Ranibizumab Treatment

Abstract Background: To evaluate the correlation between visual acuity improvement and vision-related QOL after ranibizumab treatment in Japanese patients with AMD.Methods: In this one-year prospective, interventional, open-label, multicenter study involving four sites, patients with neovascular AMD were enrolled and observed for 12 months. Treatment-naïve patients received 0.5 mg ranibizumab as needed (PRN) after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. Fluorescein and indocyanine green angiography, and evaluations with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and patient satisfaction questionnaire were performed at baseline and 3 and 12 months after initial treatment. The primary endpoint was the change in BCVA and QOL 3 months after ranibizumab treatment. Secondary endpoints included change in BCVA, QOL, CMT, and patient satisfaction over 12 months.Results: The study enrolled 100 patients. The mean logMAR BCVA after the 3-month treatment improved significantly from 0.43 to 0.30 (p<0.0001). The mean NEI-VFQ-25 composite scores were higher after 3 months of ranibizumab treatment, improving from 79.48 to 84.13 (p<0.0001). The changes in the NEI-VFQ-25 score and BCVA showed significant correlation in the poor baseline visual acuity group (decimal BCVA below 0.5, p=0.02) but not in the better baseline visual acuity group (decimal BCVA above 0.6, p=0.1) after the three loading doses. There were no significant differences in the satisfaction questionnaire score from baseline to after the three loading doses (p=0.5466). The average CMT improved significantly from 340 to 264 mm after the loading doses (p<0.0001).Conclusions: Intravitreal ranibizumab treatment resulted in improvement in visual acuity, anatomical change, and visual function change in Japanese AMD patients. Significant improvement was seen in patient visual function, but this was not correlated with changes in VA in patients with higher or lower baseline VA. The patients' satisfaction with the treatment remained unchanged during the study period.

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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.

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Visual acuity and contrast sensitivity in patients with neovascular age-related macular degeneration

Graefe s Archive for Clinical and Experimental Ophthalmology ◽

10.1007/s00417-003-0689-6 ◽

2003 ◽

Vol 241 (12) ◽

pp. 968-974 ◽

Cited By ~ 32

Author(s):

Caren Bellmann ◽

Kristina Unnebrink ◽

Gary S. Rubin ◽

Daniel Miller ◽

Frank G. Holz

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Contrast Sensitivity ◽

Age Related Macular Degeneration ◽

Age Related

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Correlation between improvement in visual acuity and QOL after Ranibizumab treatment for age-related macular degeneration patients: QUATRO study

BMC Ophthalmology ◽

10.1186/s12886-021-01816-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yuji Oshima ◽

Yumi Ishibashi ◽

Naoyasu Umeda ◽

Tatsuo Nagata ◽

Shigeo Yoshida ◽

...

Keyword(s):

Visual Acuity ◽

Visual Function ◽

Age Related Macular Degeneration ◽

Open Label ◽

Intravitreal Ranibizumab ◽

Satisfaction Questionnaire ◽

Age Related ◽

The Mean ◽

Baseline Visual Acuity ◽

Ranibizumab Treatment

Abstract Background To evaluate the correlation between visual acuity improvement and vision-related QOL after ranibizumab treatment in Japanese patients with AMD. Methods In this one-year prospective, interventional, open-label, multicenter study involving four sites, patients with neovascular AMD were enrolled and observed for 12 months. Treatment-naïve patients received 0.5 mg ranibizumab as needed after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. Evaluations with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and patient satisfaction questionnaire were performed at baseline and 3 and 12 months after initial treatment. The primary endpoint was change in BCVA and QOL 3 months after ranibizumab treatment. QOL outcomes were also assessed in the better and poor BVCA subgroups. Results The study enrolled 100 patients. The mean logMAR BCVA after treatment improved significantly from 0.43 to 0.30 at 3 months (p< 0.0001), and 0.28 at 12 months (p< 0.0001). The mean NEI-VFQ-25 composite scores improved from 79.48 to 84.13 at 3 months (p< 0.0001), and 86.0 at 12 months (p< 0.0001). The 3 and 12-month changes in NEI-VFQ-25 score and BCVA showed significant correlation. In the poor baseline visual acuity group (decimal BCVA ≤0.5), there was a significant correlation between the changes in the NEI-VFQ-25 score and BCVA (p=0.02) but not in the better baseline visual acuity group (decimal BCVA > 0.6, p=0.1) at 3 months. There were no significant differences in the satisfaction questionnaire score from baseline to at 3 months (p=0.54) and 12 months (p=0.23). The average CMT improved significantly from 340 to 264 μm at 3 months (p< 0.0001) and to 268 μm at 12 months (p< 0.0001). Conclusions Intravitreal ranibizumab treatment resulted in improvement in visual acuity, anatomical change, and visual function change in Japanese AMD patients. Significant improvement was seen in patient visual function, and this was correlated with changes in VA, except immediately after loading dose treatment in patients with higher baseline VA. The patients’ satisfaction with the treatment remained unchanged during the study period. Trial registration This study is registered at UMIN Clinical Trials Registry (UMIN000012013). Registered October 10, 2013, as prospective study.

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