Citicoline and Vitamin B12 Eye Drops in Type 1 Diabetes : Results of a 36-Month Pilot Study Evaluating Macular Electrophysiological Changes
© 2021. The Author(s)..
INTRODUCTION: Our aim was to evaluate the effects of 36 months of treatment with citicoline and vitamin B12 eye drops on macular function in patients with type 1 diabetes (DM1) with mild signs of non-proliferative diabetic retinopathy (NPDR).
METHODS: A prospective, randomized, interventional, monocentric, double-masked study was conducted. Twenty patients with DM1 were enrolled and randomly divided into two groups: the DC group (10 patients; mean age ± standard deviation 46.86 ± 8.78 years) in which one eye of each patient was treated with citicoline and vitamin B12 eye drops (OMK2®, Omikron Italia srl, Italy, one drop thrice daily) for a period of 36 months; the DP group (10 patients; mean age ± standard deviation 47.89 ± 7.74 years) in which one eye of each patient was treated with placebo (eye drops containing hypromellose 0.3%, one drop thrice daily) for a period of 36 months. A total of 18 eyes (10 from the DP and 8 from the DC group, respectively) completed the study. In both groups, multifocal electroretinogram (mfERG) recordings were assessed at baseline and after 36 months. In mfERG analysis, the N1-P1 response amplitude density (RAD) evaluated in the 0-2.5° (ring 1), in the 2.5-5° (ring 2), in the 5-10° (ring 3), and in the 0-10° (ring 1 + ring 2 + ring 3) were considered.
RESULTS: With respect to baseline, after 36 months of follow-up, the mfERG RADs recorded in R1, R2, R3, and R1 + R2 + R3 were significantly increased (i.e., R1 + R2 + R3 RAD from 21.552 ± 2.522 nV/degree2 at baseline to 26.912 ± 2.850 nV/degree2 at 36 months) in DC eyes, whereas in DP eyes they were significantly reduced (i.e., R1 + R2 + R3 RAD from 21.033 ± 3.574 nV/degree2 at baseline to 16.151 ± 3.571 nV/degree2 at 36 months).
CONCLUSIONS: This study indicates that patients with NPDR treated with citicoline and vitamin B12 eye drops for a 36-month period achieved an improvement of the macular bioelectrical responses detectable by mfERG recordings. By contrast, during the same period of follow-up, patients with NPDR treated with placebo showed a worsening of the macular function.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:38 |
|---|---|
| Enthalten in: |
Advances in therapy - 38(2021), 7 vom: 06. Juli, Seite 3924-3936 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Parisi, Vincenzo [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 05.08.2021 Date Revised 18.10.2021 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1007/s12325-021-01771-1 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM326401075 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM326401075 | ||
| 003 | DE-627 | ||
| 005 | 20231225194519.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s12325-021-01771-1 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1087.xml |
| 035 | |a (DE-627)NLM326401075 | ||
| 035 | |a (NLM)34091874 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Parisi, Vincenzo |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Citicoline and Vitamin B12 Eye Drops in Type 1 Diabetes |b Results of a 36-Month Pilot Study Evaluating Macular Electrophysiological Changes |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 05.08.2021 | ||
| 500 | |a Date Revised 18.10.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2021. The Author(s). | ||
| 520 | |a INTRODUCTION: Our aim was to evaluate the effects of 36 months of treatment with citicoline and vitamin B12 eye drops on macular function in patients with type 1 diabetes (DM1) with mild signs of non-proliferative diabetic retinopathy (NPDR) | ||
| 520 | |a METHODS: A prospective, randomized, interventional, monocentric, double-masked study was conducted. Twenty patients with DM1 were enrolled and randomly divided into two groups: the DC group (10 patients; mean age ± standard deviation 46.86 ± 8.78 years) in which one eye of each patient was treated with citicoline and vitamin B12 eye drops (OMK2®, Omikron Italia srl, Italy, one drop thrice daily) for a period of 36 months; the DP group (10 patients; mean age ± standard deviation 47.89 ± 7.74 years) in which one eye of each patient was treated with placebo (eye drops containing hypromellose 0.3%, one drop thrice daily) for a period of 36 months. A total of 18 eyes (10 from the DP and 8 from the DC group, respectively) completed the study. In both groups, multifocal electroretinogram (mfERG) recordings were assessed at baseline and after 36 months. In mfERG analysis, the N1-P1 response amplitude density (RAD) evaluated in the 0-2.5° (ring 1), in the 2.5-5° (ring 2), in the 5-10° (ring 3), and in the 0-10° (ring 1 + ring 2 + ring 3) were considered | ||
| 520 | |a RESULTS: With respect to baseline, after 36 months of follow-up, the mfERG RADs recorded in R1, R2, R3, and R1 + R2 + R3 were significantly increased (i.e., R1 + R2 + R3 RAD from 21.552 ± 2.522 nV/degree2 at baseline to 26.912 ± 2.850 nV/degree2 at 36 months) in DC eyes, whereas in DP eyes they were significantly reduced (i.e., R1 + R2 + R3 RAD from 21.033 ± 3.574 nV/degree2 at baseline to 16.151 ± 3.571 nV/degree2 at 36 months) | ||
| 520 | |a CONCLUSIONS: This study indicates that patients with NPDR treated with citicoline and vitamin B12 eye drops for a 36-month period achieved an improvement of the macular bioelectrical responses detectable by mfERG recordings. By contrast, during the same period of follow-up, patients with NPDR treated with placebo showed a worsening of the macular function | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Citicoline | |
| 650 | 4 | |a Diabetic retinopathy | |
| 650 | 4 | |a Multifocal electroretinogram | |
| 650 | 4 | |a Ophthalmology | |
| 650 | 4 | |a Vitamin B12 | |
| 650 | 7 | |a Ophthalmic Solutions |2 NLM | |
| 650 | 7 | |a Vitamins |2 NLM | |
| 650 | 7 | |a Cytidine Diphosphate Choline |2 NLM | |
| 650 | 7 | |a 536BQ2JVC7 |2 NLM | |
| 650 | 7 | |a Vitamin B 12 |2 NLM | |
| 650 | 7 | |a P6YC3EG204 |2 NLM | |
| 700 | 1 | |a Ziccardi, Lucia |e verfasserin |4 aut | |
| 700 | 1 | |a Barbano, Lucilla |e verfasserin |4 aut | |
| 700 | 1 | |a Giorno, Paola |e verfasserin |4 aut | |
| 700 | 1 | |a Varano, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Parravano, Mariacristina |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Advances in therapy |d 1990 |g 38(2021), 7 vom: 06. Juli, Seite 3924-3936 |w (DE-627)NLM085859427 |x 1865-8652 |7 nnns |
| 773 | 1 | 8 | |g volume:38 |g year:2021 |g number:7 |g day:06 |g month:07 |g pages:3924-3936 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s12325-021-01771-1 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 38 |j 2021 |e 7 |b 06 |c 07 |h 3924-3936 | ||