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Allogeneic and autologous serum eye drops: a pilot double-blind randomized crossover trial
Allogeneic and autologous serum eye drops: a pilot double-blind randomized crossover trial
- Source :
- Acta Ophthalmologica (2008), 99, 8, pp. 837-842, Acta Ophthalmologica (2008), 99, 837-842
- Publication Year :
- 2021
-
Abstract
- Contains fulltext : 243908.pdf (Publisher’s version ) (Open Access) PURPOSE: Serum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient's blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood donors does not have these disadvantages. Our aim was to evaluate whether autologous and allogeneic SEDs have comparable efficacy and tolerability. METHODS: In a prospective, double-blind crossover trial, patients with severe dry eyes were randomized to first receive autologous SEDs for one month, followed by one-month washout, before receiving allogeneic SEDs for 1 month; or receive the SED preparations in reverse order. The Ocular Surface Disease Index (OSDI) was the primary endpoint, and various secondary endpoints were determined. A linear mixed model with random intercept for each patient was applied per treatment group to compare the pre- and postoutcome measurements. RESULTS: Nineteen patients were enrolled, of whom 15 completed the trial. When autologous SEDs were used, the mean ± SD OSDI improved from 62 ± 19 to 57 ± 18. For allogeneic SEDs, the OSDI changed from 59 ± 20 to 56 ± 23. The estimated mean difference (95% confidence interval) was -4.2 (-9.5 to 1.2) for autologous and -4.5 (-9.8 to 0.9) for allogeneic SEDs (both, not significant). Adverse events were mild and resolved completely. CONCLUSION: Autologous and allogeneic SEDs have comparable efficacy and tolerability for use in patients with severe dry eyes. Allogeneic SEDs are therefore an attractive alternative for patients who need SEDs but are clinically or logistically unable to donate blood.
- Subjects :
- Male
Serum
medicine.medical_specialty
Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2]
Blood Donors
Pilot Projects
Transplantation, Autologous
Sensory disorders Donders Center for Medical Neuroscience [Radboudumc 12]
Double blind
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Clinical endpoint
medicine
Humans
Transplantation, Homologous
Ocular Surface Disease Index
Prospective Studies
Adverse effect
Aged
Cross-Over Studies
business.industry
General Medicine
Autologous serum
Crossover study
Confidence interval
Surgery
Ophthalmology
Tolerability
030221 ophthalmology & optometry
Dry Eye Syndromes
Female
Ophthalmic Solutions
business
030217 neurology & neurosurgery
Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5]
Follow-Up Studies
Subjects
Details
- ISSN :
- 17553768 and 1755375X
- Volume :
- 99
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Acta ophthalmologica
- Accession number :
- edsair.doi.dedup.....6194fad97f527e3e758f90d16f84f70a