Autologous versus allogeneic versus umbilical cord sera for the treatment of severe dry eye disease: a double-blind randomized clinical trial.

Sjögren’s syndrome allogeneic serum eye drops autoimmune disease autologous serum eye drops dry eye growth factor haemoderivatives eye drops ocular surface umbilical cord serum eye drops

Journal

Acta ophthalmologica
ISSN: 1755-3768
Titre abrégé: Acta Ophthalmol
Pays: England
ID NLM: 101468102

Informations de publication

Date de publication:
Mar 2022
Historique:
received: 08 01 2021
accepted: 31 05 2021
pubmed: 18 6 2021
medline: 1 3 2022
entrez: 17 6 2021
Statut: ppublish

Résumé

To measure the effects of Autologous serum (AS), Allogeneic Serum (HS) and Umbilical Cord serum (CS) eye drops in severe dry eye disease (DES), as well as to characterize and quantify several molecules in the three sera (albumin, fibronectin; Vitamin A and E; IgG, IgA and IgM; Transforming growth factor β; Epithelial growth factor). Randomized, double-blind, single-centre, three-arm (AS, HS and CS) clinical trial. Sixty-three subjects were included with severe DES, 21 in each arm of the study. Visual acuity, Schirmer test, Breakup time (BUT), lissamine green, fluorescein staining measurements and a questionnaire were performed prior to treatment, and after one-month and three-month follow-up. There was a significant main effect of time on visual acuities, Schirmer and BUT tests and fluorescein and lissamine green staining measurements and questionnaire scores (p = 0.015, p = 0.002, p < 0.001, p < 0.001, p = 0.031 and p < 0.001, respectively), although there was no significant interaction between time and serum type, nor between serum type and the test performed. Regarding the concentration of molecules, in our study AS contained significantly higher concentrations of IgA, IgG and fibronectin whereas HS contained significantly higher concentration of IgM, vitamins A and E, TGF and albumin. Contrary to previous reports, CS did not show higher concentration of any of the molecules analysed. The three sera were effective in the treatment of severe DES. CS did not contain a higher proportion of molecules compared to AS/HS. More research is needed to assess the effect of AS in patients with DES and autoimmune diseases.

Identifiants

pubmed: 34137177
doi: 10.1111/aos.14953
doi:

Substances chimiques

Ophthalmic Solutions 0

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

e396-e408

Subventions

Organisme : Ministry of Health within the framework of the Aid for Independent Clinical Research of 2011
ID : EC11-506

Informations de copyright

© 2021 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

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Auteurs

Marina Rodríguez Calvo-de-Mora (M)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.
Qvision, Department of Ophthalmology, Vithas, Almería, Spain.

Cayetano Domínguez-Ruiz (C)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.

Francisco Barrero-Sojo (F)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.

Gustavo Rodríguez-Moreno (G)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.

Cristina Antúnez Rodríguez (C)

Centro Regional de Transfusiones, Málaga, Spain.

Laura Ponce Verdugo (L)

Centro Regional de Transfusiones, Málaga, Spain.

María Del Carmen Hernández Lamas (MDC)

Centro Regional de Transfusiones, Málaga, Spain.

Luisa Hernández-Guijarro (L)

Hospital Quirón Salud, Málaga, Spain.

Jacinto Villalvilla Castillo (J)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.

Idefonso Fernández-Baca Casares (I)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.

Isidro Prat Arrojo (I)

Centro Regional de Transfusiones, Málaga, Spain.

Davide Borroni (D)

The Veneto Eye Bank Foundation, Venice, Italy.
Department of Doctoral Studies, Riga Stradins University, Riga, Latvia.

Carmen Alba-Linero (C)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.

Francisco Zamorano-Martín (F)

Ophthalmology Department, Hospital Regional Universitario, Málaga, Spain.

Antonio Moreno-Guerrero (A)

Ophthalmology Department, Málaga University, Spain.

Carlos Rocha-de-Lossada (C)

Qvision, Department of Ophthalmology, Vithas, Almería, Spain.
Ophthalmology Department, Hospital Virgen de las Nieves, Granada, Spain.

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