AUTOLOGOUS SERUM-BASED EYE DROPS FOR TREATMENT OF OCULAR SURFACE DISEASE
A Report by the American Academy of Opthalmology
�The first ophthalmic use was reported in 1975 for the treatment of ocular burn using an ocular perfusion pump to deliver a variety of solution, including serum or plasma to the ocular surface.
After further studies showed patient improvement, the used of serum tears for ocular surface disease become more widely accepted.
INTRODUCTION
In 1984, the topical use of serum for the treatment of Sjogren’s related dry eye was reported and all of the patients noted improved symptoms, and no adverse events were reported.
Over the past 20 years, treatment of ocular surface disease using autologous serum tears has expanded.
PURPOSE
To describe the safety and effectiveness of using autologous serum-based eye drops for the treatment of severe dry eye and persistent corneal epithelial defect.
METHODS
Composition & Function of the Serum
facilitate the recovery of damaged corneal and conjunctival epithelium, thus reducing the signs and symptoms of ocular surface disease (OSD).
PUBLISHED REPORT
Table 1 : Summary of Included Studies (Ophthalmology Volume 127, Number 1, January 2020)
Table 2: Autologous Serum Results
Authors (Year) | Title | Level of Evidence | Dilution (%) | No. of Participants | Age (yrs; Mean ± Standard Deviation) | Gender (%; Female/Male) | Condition | Follow-up (mos) |
Noda-Tsuruya et al15 (2006) | Autologous serum eye drops for dry eye after LASIK | II | 20 | 27 | 30 6 | 0/100 | DED | 6 |
Yoon et al16 (2007) | Comparison of autologous serum and umbilical cord serum eye drops for dry | II | 20 | 48 | 40 11 | 52/48 | DED | 2 |
Kim et al17 | eye syndrome Effect of autologous platelet-rich plasma | II | 20 | 17 | 67 | 41/59 | PED | 1 |
(2012) Cho et al8 | on persistent corneal epithelial defect after infectious keratitis Comparison of autologous serum eye | II | 100 | 85 | NR | 61/39 | DED, PED | 3 |
(2013) Celebi et al7 (2014) | drops with different diluents The efficacy of autologous serum eye drops for severe dry eye syndrome: a | II | 20 | 20 | 56 8 | 190/10 | DED | 2 |
Hussain et al9 (2014) | randomized double-blind crossover study Long-term use of autologous serum 50% eye drops for the treatment of dry eye | II | 50 | 63 | 61 11 | 83/17 | DED | 12 |
Hwang et al10 (2014) | disease Comparison of clinical efficacies of autologous serum eye drops in patients | II | 50 | 34 | 56 9 | 100/0 | DED | 1 |
Lopez-Garcia et al13 (2014) | with primary and secondary Sjögren syndrome Autologous serum eye drops diluted with sodium hyaluronate: clinical and | II | 20 | 52 | 52 13 | 92/8 | DED | 2 |
Liu et al12 (2015) | experimental comparative study Effectiveness of autologous serum eye drops combined with punctal plugs for | III | 20 | 28 | 56 14 | 89/11 | DED | 42 |
Lee and Chen11 (2008) | the treatment of Sjögren syndrome- related dry eye Autologous serum in the management of recalcitrant dry eye syndrome | III | 20 | 23 | 63 14 | 83/17 | DED | 17 |
Lekhanont et al18 (2013) | Topical 100% serum eye drops for treating corneal epithelial defect after | III | 100 | 181 | 62 14 | 51/49 | PED | 3 |
Semeraro et al19 (2014) | ocular surgery Evaluation of the efficacy of 50% autologous serum eye drops in different | III | 50 | 15 | 40 17 | NR | PED | 4 |
Mahelkova et al14 (2017) | ocular surface pathologies Using corneal confocal microscopy to track changes in the corneal layers of | III | 20 | 26 | 51 14 | 73/27 | DED | 3 |
| dry eye patients after autologous serum treatment | | | | | | | |
DED ¼ dry eye disease; NR ¼ not reported; PED ¼ persistent epithelial defect.
Authors (Year) | Level of Evidence | Dilution (%)* | Condition | Follow-up (mos) | Visual Acuity | Surface Stain | Schirmer’s Test Results | Tear Film Breakup Time | Cytologic Analysis Results | Persistent Epithelial Defect Healed (%) | Symptoms | Side Effects |
Noda-Tsuruya et al15 (2006) | II | 20 | DED | 6 | NR | Improved but not SSI | Unchanged | SSI | NR | NA | Unchanged | None |
Yoon et al16 (2007) | II | 20 | DED | 2 | NR | SSI | Unchanged | SSI | SSI | NA | SSI | NR |
Cho et al8 (2013) | II | 50/100 | DED | 3 | NR | SSI | SSI | SSI | NR | NA | SSI | MGBy |
Celebi et al7 (2014) | II | 20 | DED | 2 | NR | SSI | NR | SSI | NR | NA | SSI | None |
Hussain et al9 (2014) | II | 50 | DED | 12 | NR | Improved | Improved | NR | NR | NA | Improved | None |
| | | | | | but not SSI | but not SSI | | | | but not SSI | |
Hwang et al10 (2014) | II | 50 | DED (1◦ SS) | 1 | NR | SSI | NR | SSI | NR | NA | SSI | NR |
| | 50 | DED (2◦ SS) | 1 | NR | Improved | NR | Improved | NR | NA | Improved | NR |
| | | | | | but not SSI | | but not SSI | | | but not SSI | |
Lopez-Garcia et al13 (2014) | II | 20/saline | DED | 2 | Unchanged | SSI | Improved but not SSI | SSI | SSI | NA | SSI | None |
| | 20/hyaluronidase | DED | 2 | Unchanged | SSI | Improved | SSI | SSI | NA | SSI | None |
| | | | | | | but not SSI | | | | | |
Liu et al12 (2015) | II | 20 | DED | 42 | NR | SSI | Unchanged | SSI | NR | NA | NR | None |
Lee and | III | 20 | DED | 17 | NR | Improved | NR | NR | NR | NA | Improved | None |
Chen11 (2008) | | | | | | but not SSI | | | | | but not SSI | |
Mahelkova et al14 (2017) | III | 20 | DED | 3 | NR | SSI | NR | NR | NR | NA | SSI | None |
Kim et al17 (2012) | II | 20 | PED | 1 | NR | NR | NR | NR | NR | 71 | NR | NR |
Cho et al8 (2013) | II | 50/100 | PED | 3 | NR | SSI | SSI | Unchanged | NR | 100 | SSI | MGBz |
Lekhanont et al18 (2013) | III | 100 | PED | 3 | NR | NR | NR | NR | NR | 94 | NR | None |
Semeraro et al19 (2014) | III | 50 | PED | 4 | SSI | NR | NR | NR | NR | 100 | SSI | None |
Table 2. Autologous Serum Results
DED ¼ dry eye disease; MGB ¼ microbial growth in bottle; NA ¼ not applicable; NR ¼ not reported; PED ¼ persistent epithelial defect; SS ¼ Sjögren’s syndrome; SSI ¼ statistically significantly improved.
*Percent autologous serum used.
yNo clinical infection.
zCorrelated with microbe in corneal lesion.
Shtein et al
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Ophthalmic Technology Assessment
SEVERE DRY EYE DISEASES CASE STUDIES
6 studies shows statistically significant improvement
1 reported no change in symptom scores
1study did not report on patient symptoms
SEVERE DRY EYE DISEASES CASE STUDIES
Another study compare then treatment effectiveness in primary versus secondary Sjogren’s syndrome and suggested that autologous serum based eye drops work better for patients with primary Sjogren’s syndrome.
A different study compare the diluent (normal saline vs sodium hyaluronate) and showed no statistical difference
SEVERE DRY EYE DISESES CASE STUDIES
NONHEALING CORNEAL EPITHELIAL DEFECT
2 with level II evidence
2 with level III evidence
NONHEALING CORNEAL EPITHELIAL DEFECT
CONCLUSION
Although autologous serum-based tears may be effective in the treatment of severe dry eye and persistent epithelial defect, conclusions are limited owing to the absence of controlled trials.