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. 2013 Aug 27;8(8):CD009327.
doi: 10.1002/14651858.CD009327.pub2.

Autologous serum eye drops for dry eye

Qing Pan  1 , Adla Angelina, Andrea Zambrano, Michael Marrone, Walter J Stark, Thomas Heflin, Li Tang, Esen K Akpek
Affiliations

Autologous serum eye drops for dry eye

Qing Pan et al. Cochrane Database Syst Rev. .

Update in

  • Autologous serum eye drops for dry eye.
    Pan Q, Angelina A, Marrone M, Stark WJ, Akpek EK. Pan Q, et al. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD009327. doi: 10.1002/14651858.CD009327.pub3. Cochrane Database Syst Rev. 2017. PMID: 28245347 Free PMC article.

Abstract

Background: =Theoretically, autologous serum eye drops (AS) have a potential advantage over traditional therapies based on the assumption that ASserve not only as a lacrimal substitute to provide lubrication, but also contain other biochemical components mimicking natural tears more closely. The application of AS in dry eye treatment has gained popularity as a second-line therapy in the treatment of dry eye.Published studies on the subject indicate that autologous serum could be an effective treatment for dry eye.

Objectives: To evaluate the efficacy and safety of AS compared to artificial tears for treating dry eye.

Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 3),Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE,(January 1950 to April 2013), EMBASE (January 1980 to April 2013), Latin American and Caribbean Literature on Health Sciences(LILACS) (January 1982 to April 2013), themetaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov(www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We also searched the Science Citation Index Expanded database (September 2013) and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 15 April 2013.

Selection criteria: We included randomized controlled trials (RCTs) in which AS was compared to artificial tears in the treatment of dry eye in adults.

Data collection and analysis: Two review authors independently screened all titles and abstracts and assessed full-text articles of potentially eligible trials. Two review authors extracted data and assessed the methodological quality and characteristics of the included trials.We contacted investigators for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals(CIs) for continuous outcomes.

Main results: We identified four eligible RCTs in which AS was compared with artificial tear treatment or saline in individuals (n = 72 participants)with dry eye of various etiologies (Sjögren’s syndrome-related dry eye, non-Sjögren’s syndrome dry eye and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)). The quality of the evidence provided by these trials was variable. A majority of the risk of bias domains were judged to have an unclear risk of bias in two trials owing to insufficient reporting of trial characteristics.One trial was considered to have a low risk of bias for most domains while another was considered to have a high risk of bias for most domains. Incomplete outcome reporting and heterogeneity in the participant populations and follow-up periods prevented the inclusion of these trials in a summary meta-analysis. For the primary outcome, improvement in participant-reported symptoms at one month, one trial (12 participants) showed no difference in participant-reported symptoms between 20% AS and artificial tears. Based on the results of two trials in 32 participants, 20% AS may provide some improvement in participant-reported symptoms compared to traditional artificial tears after two weeks of treatment. One trial also showed positive results with a mean difference in tear breakup time (TBUT) of 2.00 seconds (95% CI 0.99 to 3.01 seconds) between 20% AS and artificial tears after two weeks, which were not similar to findings from the other trials. Based on all other objective clinical assessments included in this review, AS was not associated with improvements in aqueous tear production measured by Schirmer's test (two trials, 33 participants), ocular surface condition with fluorescein (four trials, 72 participants) or Rose Bengal staining (three trials, 60 participants), and epithelial metaplasia by impression cytology compared to artificial tears (one trial, 12 participants). Data on adverse effects were not reported by three of the included studies. In one study, there were no serious adverse events reported with the collection of and treatment with AS.

Authors' conclusions: Overall there was inconsistency in the possible benefits of AS in improving participant-reported symptoms and TBUT and lack of effect based on other objective clinical measures. Well-planned, large, high-quality RCTs are warranted, in different severities of dry eye and using standardized questionnaires to measure participant-reported outcomes and objective clinical tests as well as objective biomarkers to assess the benefit of AS therapy for dry eye.

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Conflict of interest statement

DECLARATIONS OF INTEREST

No authors have conflicts of interest to report.

Figures

Figure 1
Figure 1
Results from searching for studies for inclusion in the review
Figure 2
Figure 2
Methodological quality summary: risk of bias review authors’ judgements about each risk of bias item for each included study.
Analysis 1.1
Analysis 1.1
Comparison 1 Autologous serum (20%) versus artificial tears, Outcome 1 Participant-reported symptoms (severe dry eye).
Analysis 1.2
Analysis 1.2
Comparison 1 Autologous serum (20%) versus artificial tears, Outcome 2 Rose Bengal (severe dry eye).
Analysis 1.3
Analysis 1.3
Comparison 1 Autologous serum (20%) versus artificial tears, Outcome 3 Rose Bengal (post-LASIK dry eye).
Analysis 1.4
Analysis 1.4
Comparison 1 Autologous serum (20%) versus artificial tears, Outcome 4 Fluorescein (severe dry eye).
Analysis 1.5
Analysis 1.5
Comparison 1 Autologous serum (20%) versus artificial tears, Outcome 5 Schirmers I test (severe dry eye).
Analysis 1.6
Analysis 1.6
Comparison 1 Autologous serum (20%) versus artificial tears, Outcome 6 TBUT (severe dry eye).
Analysis 1.7
Analysis 1.7
Comparison 1 Autologous serum (20%) versus artificial tears, Outcome 7 TBUT (post-LASIK dry eye).
Analysis 2.1
Analysis 2.1
Comparison 2 Autologous serum (20%) versus saline solution, Outcome 1 Participant-reported symptoms (severe dry eye).
Analysis 2.2
Analysis 2.2
Comparison 2 Autologous serum (20%) versus saline solution, Outcome 2 Rose Bengal (severe dry eye).
Analysis 2.3
Analysis 2.3
Comparison 2 Autologous serum (20%) versus saline solution, Outcome 3 Fluorescein (severe dry eye).
Analysis 2.3
Analysis 2.3
Comparison 2 Autologous serum (20%) versus saline solution, Outcome 3 Fluorescein (severe dry eye).
Analysis 2.4
Analysis 2.4
Comparison 2 Autologous serum (20%) versus saline solution, Outcome 4 Schirmers I test (with anesthesia) (severe dry eye).
Analysis 2.5
Analysis 2.5
Comparison 2 Autologous serum (20%) versus saline solution, Outcome 5 TBUT (severe dry eye).
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References

References to studies included in this review

    1. Kojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, et al. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. American Journal Ophthalmology. 2005;139(2):242–246. - PubMed
    1. Kojima T, Ishida R, Goto E, Matsumoto Y, Dogru M, Tsubota K. The efficacy of autologous serum eye drops for Keratoconjunctivitis Sicca - A prospective study. Investigative Ophthalmology and Visual Science. 2004;45 ARVO E-abstract 3894.
    1. Noda-Tsuruya T, Asano-Kato N, Toda I, Tsubota K. Autologous serum eye drops for dry eye after LASIK. Journal of Refractive Surgery. 2006;22(1):61–66. - PubMed
    1. Tananuvat N, Daniell M, Sullivan LJ, Yi Q, McKelvie P, McCarty DJ, et al. Controlled study of the use of autologous serum in dry eye patients. Cornea. 2001;20(8):802–806. - PubMed
    1. Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Current Eye Research. 2012;37(8):684–688. - PubMed

References to studies excluded from this review

    1. Albegger KW, Tilz GP. Sjogren’s syndrome and its therapy. A therapeutic attempt using antilymphocyte serum [Zum Sjogren–syndrom und seiner behandlung. Ein therapieversuch mit antilymphozytenglobulin] Zeitschrift Fur Laryngologie, Rhinologie, Otologie Und Ihre Grenzgebiete. 1972;51(7):429–437. - PubMed
    1. Alvarado Valero MC, Martinez Toldos JJ, Borras Blasco J, Alminana Alminana A, Perez Ramos JM. Treatment of persistent epithelial defects using autologous serum application [Tratamiento de defectos epiteliales persistentes mediante suero autologo] Archivos De La Sociedad Espanola De Oftalmologia. 2004;79(11):537–542. - PubMed
    1. Anderson NG, Regillo C. Ocular manifestations of graft versus host disease. Current Opinion in Ophthalmology. 2004;15(6):503–507. - PubMed
    1. Badami K, McKellar M. Allogeneic serum eye drops-a useful alternative for those unable to be autologous donors. Transfusion; Proceedings of the AABB Annual Meeting and TXPO; New Orleans (LA). 2009 Oct 24–27.2009.
    1. Bradley JC, Bradley RH, Mccartney DL, Mannis MJ. Serum growth factor analysis in dry eye syndrome. Clinical and Experimental Ophthalmology. 2008;36(8):717–720. - PubMed

Additional references

    1. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practive Pattern Guidlines. Dry Eye Syndrome - Limited Revision. San Francisco, CA: American Academy of Ophtalmology; 2011. Vol. Available at: www.aao.org/ppp.
    1. Akpek EK, Lindsley KB, Adyanthaya RS, Swamy R, Baer AN, McDonnel PJ. Treatment of Sjögren’s Syndrome-associated dry eye. Ophthalmology. 2011;118:1242–1252. - PubMed
    1. Afonso AA, Monroy D, Stern ME, Feuer WJ, Tseng SC, Pflugfelder SC. Correlation of tear fluorescein clearance and Schirmer test scores with ocular irritation symptoms. Ophthalmology. 1999;106(4):803–810. - PubMed
    1. Baudouin C. The pathology of dry eye. Survey of Ophthalmology. 2001;45(Suppl 2):S211–S220. - PubMed
    1. Baoudouin C, Labbe A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Progress in Retinal and Eye Research. 2010;29(4):321–334. - PubMed

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