Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.
Autologous Serum exhibits characteristics very similar to those of tears, such as pH, osmolarity, vitamins, and Immunoglobulin A. It also contains growth factors, nutritional factors, and antibacterial components that are necessary for the maintenance of cellular viability in the epithelial repair process. The use of autologous serum eye drops was first described in 1984 by Fox et al., in research for a preservative-free tear substitute. Subsequently, in 1999, Tsubota et al. found that, due to the presence of growth factors and vitamins, autologous serum could have a true epithelial trophic potential for the ocular surface. The autologous serum eye drops are not only a lubricant for the ocular surface but also provide various essential substances for the reconstruction of epithelial damage, including vitamin A, epithelial growth factor, fibronectin, and a variety of cytokines. With these epithelial trophic factors, autologous serum facilitates proliferation, migration, and differentiation of the ocular surface epithelium. Moreover, it is known for its anti-catabolic properties, inhibiting the inflammatory cascade triggered by interleukin-1, which prevents tissue destruction. Therefore, autologous serum eye drops have been effective in the treatment of persistent epithelial defects, neurotrophic ulcers, superior limbic keratoconjunctivitis, dry eye conditions, graft-versus-host disease (GVHD), or after refractive surgeries, such as LASIK (Laser Assisted In Situ Keratomileusis). In 2020, Wang et al. published an article with 7 randomized controlled trials comparing the use of autologous serum versus artificial tears in patients with dry eye syndrome. In the meta-analysis, all 7 studies evaluated subjective symptoms and showed that autologous serum eye drops were superior to ocular lubricants in alleviating and remitting symptoms. It was shown that autologous serum eye drops significantly improved parameters such as OSDI (Ocular Surface Disease Index), tear break-up time, and Bengal Rose staining when compared to the control group using ocular lubricants. Given the numerous properties of autologous serum eye drops, there is no doubt about their benefit and effectiveness in treating several ocular surface diseases, including ocular GVHD. However, the difficulty in accessing production and the substantial cost of autologous serum eye drops are the main challenges, and their use is often limited to more severe dry eye cases and those refractory to conventional treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
The collection of autologous serum in a closed blood processing system for ocular use
HCFMUSP
São Paulo, São Paulo, Brazil
Feasibility of using the collection device under testing
Proportion of blood collections that resulted in successful production of final autologous serum containers suitable for patient use.
Time frame: 2 years
Median pre-freezing number of leukocytes in autologous serum
0.0-0.03x10ˆ3/mcL;
Time frame: 2 years
Median pre-freezing number of red blood cells in autologous serum
0.0-0.03x10ˆ6/mcL;
Time frame: 2 years
Median pre-freezing number of platelets in autologous serum
0.0-0.03x10ˆ3/mcL;
Time frame: 2 years
Median pre and post-freezing pH in autologous serum
7.00-7.50;
Time frame: 2 years
Pre-freezing microbiological test of autologous serum
Positive or negative;
Time frame: 2 years
NIH ocular score
0-3
Time frame: baseline, 6 weeks, 12 weeks, and end of treatment
Ocular Surface Disease Index
Reported by the patient from 0 to 100
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Global ocular symptom score
Reported by the patient from 0 to 10
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Lee score ocular subscale
Reported by the patient from 0 to 100
Time frame: Baseline, 6 weeks, 12 weeks, and end of treatment
Corneal staining score (fluorescein)
Bijsterveld scale: 0-9.
Time frame: Baseline, 6 weeks, 12 weeks
Corneal staining score (Rose Bengal)
Bijsterveld scale: 0-9.
Time frame: Baseline, 6 weeks, 12 weeks
Meibography
Good, moderate, poor
Time frame: Baseline, 6 weeks, 12 weeks
Schirmer test
0-30 mm in 5 minutes
Time frame: Baseline, 6 weeks, 12 weeks
Non-invasive tear film break-up
0-50 seconds
Time frame: Baseline, 6 weeks, 12 weeks
Tear film lipid layer
0-3
Time frame: Baseline, 6 weeks, 12 weeks
Adherence to the use of autologous serum
Percentage of doses administered vs. planned doses: 0-100%
Time frame: At 6 and 12 weeks post-treatment
Patient's qualitative evaluation of the use of autologous serum
Qualitative questionnaire
Time frame: At 12 weeks post-treatment
Team's qualitative perception of the feasibility of collection and production of autologous serum
Qualitative questionnaire
Time frame: At 50% of planned recruitment
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