Intervention Review

You have free access to this content

Autologous serum eye drops for dry eye

  1. Qing Pan1,2,*,
  2. Adla Angelina3,
  3. Andrea Zambrano4,
  4. Michael Marrone5,
  5. Walter J Stark4,
  6. Thomas Heflin4,
  7. Li Tang6,
  8. Esen K Akpek4

Editorial Group: Cochrane Eyes and Vision Group

Published Online: 27 AUG 2013

Assessed as up-to-date: 15 APR 2013

DOI: 10.1002/14651858.CD009327.pub2


How to Cite

Pan Q, Angelina A, Zambrano A, Marrone M, Stark WJ, Heflin T, Tang L, Akpek EK. Autologous serum eye drops for dry eye. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD009327. DOI: 10.1002/14651858.CD009327.pub2.

Author Information

  1. 1

    Johns Hopkins University School of Medicine, Wilmer Eye Institute, Baltimore, MD, USA

  2. 2

    Zhejiang Provincial People's Hospital, Department of Ophthalmology, Hangzhou, Zhejiang, China

  3. 3

    University of Mississippi School of Medicine, Department of Pathology, Jackson, MS, USA

  4. 4

    Johns Hopkins University School of Medicine, Department of Ophthalmology, Baltimore, MD, USA

  5. 5

    Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, Maryland, USA

  6. 6

    Affiliated Hospital of Guiyang Medical College, Ophthalmology Department, Guiyang, Guizhou Province, China

*Qing Pan, panqing@hotmail.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 27 AUG 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Kojima 2005a

MethodsStudy design: "prospective randomized case-control study" 

Unit of randomization: (Individuals/eyes): 20 individuals (37 eyes) 

Unit of analysis (Individuals/eyes): individuals 

Number randomized

Total: 20

Per group: 10

Number analyzed 

Total: 20

Per group: 10 

Was an intention-to-treat analysis performed? (Yes/No): No


ParticipantsCountry: Japan

Age:  

AS: 62.3 ∓ 12.5

artificial tears: 65.4 ∓ 9.7

Gender:

AS: 2 men and 8 women

artificial tears: 2 men and 8 women

Underlying conditions: 9 of the 10 participants in artificial tear group and 8 of the 10 participants in the AS had Sjögren's Syndrome

Inclusion criteria:

All participants met the diagnostic criteria of the Japanese Dry Eye Research group:

Schirmer 1 test < 5 mm, or tear film BUT < 5 seconds

Exclusion criteria:

History of punctal occlusion, ocular or systemic disease, or a history of drug or contact lens use that would alter the ocular surface


InterventionsTreatment or Intervention 1: 20% AS (saline)

Control or Intervention 2: preservative-free artificial tears

Length of follow-up:

Planned: 2 weeks

Actual: 2 weeks


OutcomesVISUAL ANALOG PAIN SYMPTOM SCORE: Absence of any pain constituted a score of 0 points on the visual analog pain scales, and intense, unbearable pain was considered a full pain score of 100 points. 

Tear function: Tear film BUT was measured 3 times, and the mean value was calculated. The tear film BUT was considered abnormal if it was less than 5 seconds. Schirmer's test was considered abnormal if it was less than 5 mm. 

Ocular surface: The ocular surface was examined by the double vital staining method. 2 milliliters of a preservative-free combination of 1% Rose Bengal and 1% fluorescein dye was instilled in the conjunctival sac. 

“According to the study protocol, tear film BUT analysis was performed initially, followed by fluorescein and Rose Bengal vital staining of the ocular surface. The Schirmer 1 test was then performed. Tear film BUT, vital staining of the ocular surface, and visual analog pain symptom scores were compared before and after treatment”


NotesType of study (published/unpublished) and journal of publication: published in the American Journal of Ophthalmology 

Presented at the 28th Japan Cornea Congress, February 19 – 21, 2003, Yonago, Japan, and at the 2004 ARVO Meeting, Fort Lauderdale, Florida, April 26, 2004. 

Source of Funding: Japanese Ministry of Education and Science (Tokyo) and Hightech Research Center at Tokyo Dental College (Chiba, Japan) 

Study author provided additional information not included in published report.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"After washout, all patients were randomly assigned to two groups..."

Allocation concealment (selection bias)Unclear risk"After washout, all patients were randomly assigned to two groups..."

Masking of participants of the allocated intervention (Performance bias).Unclear riskThe study described the collection and production of autologous serum including venipuncture as well as storage requirement, but it was unclear whether only the autologous serum group underwent the necessary collection procedures or received the same storage instructions. 

Masking of study personnel of the allocated intervention (Performance bias)Unclear riskNo information was provided in the published report to determine whether study personnel were aware of each participant's treatment assignment. Specific instructions were given to study participants regarding the proper care and storage of the autologous serum vials.

Masking of outcome assessors during follow-up – patient reported symptoms ( Detection bias)Unclear risk"patients were asked to check a point on the line corresponding to their degree of pain"

Masking of outcome assessors during follow-up – clinical examination (Detection bias)Low risk“The examiner who carried out the tear function and ocular surface evaluations was masked to the type of the eyedrops prescribed to the patients in this study”

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskA total of 39 eyes from 20 participants were analyzed and reported in a conference abstract, while 37 eyes from 20 patients were analyzed in the full-text publication. No explanation given for eyes excluded in the full-text report.

Selective reporting (reporting bias)Low riskAll outcomes were reported as described in the methods.

Other biasLow riskNo other potential sources of bias were identified.

Noda-Tsuruya 2006

MethodsStudy design: Prospective randomized study 

Unit of randomization: (Individuals/Eyes): individuals 

Unit of analysis (Individuals/Eyes): eyes 

Number randomized:

Total: 27 participants (54 eyes)

Per group:

AS: 12 participants (24 eyes)

artificial tears: 15 participants (30 eyes) 

Number of eyes analyzed:

1 month

BUT: AS 20, artificial tears 23

Schirmer’s: AS 20, artificial tears 19

Rose Bengal: AS 20, artificial tears 15

Fluorescein: AS 20, artificial tears 23

3 months

BUT: AS 18, artificial tears 15

Schirmer’s:    AS 16, artificial tears 15

Rose Bengal:  AS 16, artificial tears 11

Fluorescein:   AS 18, artificial tears 15

6 months

BUT: AS 8, artificial tears10

Schirmer’s: AS 8, artificial tears 10

Rose Bengal: AS 6, artificial tears 10

Fluorescein: AS 8, artificial tears 10 

Was an intention-to-treat analysis performed? (Yes/No): No


ParticipantsCountry: Japan

Age: 30.1 ∓ 5.8

Gender: 100% men 

Underlying conditions: All participants had LASIK surgery one week prior to start of study. No others reported 

Concurrent dry eye treatments: One week after LASIK surgery all participants received topical steroids, antibiotics and hyaluronic acid eye drops 5 times per day and discontinued use at 1 week postoperatively 

Inclusion criteria: post-LASIK male participants, no others reported.

“All patients revealed normal findings by routine preoperative ophthalmologic examination including tear function and vital staining. None of the patients had worn contact lenses before LASIK.” 


InterventionsTreatment or Intervention 1: 20% AS (saline) 

Control or Intervention 2: artificial tears: unpreserved, saline-based (Softsantear, Santen)

Length of follow-up:

Planned: 1 week post-LASIK to 6 months post-LASIK

Actual: 1 week post-LASIK to 6 months post-LASIK


OutcomesParticipant questionnaire: Dry eye symptoms were graded by the participants using a written questionnaire according to the following criteria: 0, none; 1, mild; 2, moderate; 3, strong; and 4, very strong.

Tear function: Schirmer test with anesthesia, tear clearance rate, and tear break-up time (BUT)

Ocular surface staining: Fluorescein staining was graded from 0 to 3 for each of the upper, middle, and lower thirds of the cornea. Rose bengal staining was graded from 0 to 3 for the temporal conjunctiva, cornea, and nasal conjunctiva. The grading scale was decided according to the extent of staining; 0, negative; 1, minute scattering; 2, moderately spotty; and 3, diffuse blotchy staining. Total of scores in the 3 areas was defined as fluorescein or Rose Bengal score.


NotesType of study (published/unpublished) and journal of publication: published in the Journal of Refractive Surgery

Source of Funding: not reported

Reported subgroup analyses: none reported

Contacted author for additional information, but did not receive additional information not included in published report.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"All candidates for the study were selected, and patients were randomly divided into two groups"

Allocation concealment (selection bias)Unclear risk"All candidates for the study were selected, and patients were randomly divided into two groups"

Masking of participants of the allocated intervention (Performance bias).Unclear riskThe study described the collection and production of autologous serum including venepuncture as well as storage requirement, but it was unclear whether only the autologous serum group underwent the necessary collection procedures or received the same storage instructions. 

Masking of study personnel of the allocated intervention (Performance bias)Unclear riskNo information was provided in the published report to determine whether study personnel were aware of each participant's treatment assignment. But specific instructions were given to study participants regarding the proper care and storage of the autologous serum vials.

Masking of outcome assessors during follow-up – patient reported symptoms ( Detection bias)Unclear risk"Typical dry eye symptoms were graded by the patients using a written questionnaire according to the following criteria: 0, none; 1, mild; 2, moderate; 3, strong; and 4, very strong."

Masking of outcome assessors during follow-up – clinical examination (Detection bias)Unclear risk"To evaluate tear function, Schirmer test with anesthesia, tear clearance rate, and tear break-up time (BUT) were measured as previously described." No other description discussing whether outcome assessment was done by a masked investigator.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskStudy reported the number of eyes for each outcome at all time point across both treatment arms, but did not give reasons for missing outcome data.

Selective reporting (reporting bias)Unclear riskReported all outcomes at all time points for outcomes described in the methods, although reported information was insufficient to extract usable data for quantitative summary analysis.

Other biasUnclear riskUnit of randomization was the participant while the reported results were per eye.

Tananuvat 2001

MethodsStudy design: Prospective, single-masked, placebo-controlled, paired-eye study

Unit of randomization: (Individuals/Eyes): eyes 

Unit of analysis (Individuals/Eyes): eyes 

Number randomized

Total: 13

Per group: 13 

Exclusions after randomization and reasons for exclusion  "One patient with ocular cicatricial pemphigoid was excluded after enrollment because of asymmetry of the severity of dry eye between the two eyes” 

Losses to follow-up and reasons for loss to follow-up  none reported 

Number analyzed  

Total: 12

Per group: 12 

Was an intention-to-treat analysis performed? (Yes/No): No


ParticipantsCountry:  Australia 

Age: mean 59.5 (range: 33 - 80) 

Gender:

Men: 5

Women: 7 

Underlying conditions: 5 participants had Sjögren’s syndrome, 2 participants had primary Sjögren’s syndrome and 3 had secondary Sjögren’s syndrome. The non-Sjögren’s type dry eyes included non-Hodgkin’s lymphoma (n = 1), graft-versus-host disease (n = 1), Stevens-Johnson syndrome (n = 1), rheumatoid arthritis (n = 1), and 3 idiopathic 

Concurrent dry eye treatments: artificial tears as needed 

Inclusion criteria: "Patients with bilateral severe dry eye were enrolled in this study. All had low Schirmer test scores and positive rose bengal staining and symptoms of dry eye despite frequent lubricants or previous punctal occlusion". 

Exclusion criteria: "Patients were excluded if they had active ocular infection or inflammation not related to dry eye, had ocular surgery within 3 months, were monocular, or had other conditions that may mimic dry eye symptoms such as allergic conjunctivitis or lid or lash abnormalities"


InterventionsTreatment or Intervention 1: 20% AS  

Control or Intervention 2: unpreserved saline solution and dilute fluorescein solution

Length of follow-up:

Planned: 2 months

Actual: 2 months


OutcomesParticipant questionnaire: Symptoms of dry eye (discomfort, foreign-body sensation, dryness, and photophobia) were recorded at every visit and graded according to the severity as grade 0, no symptom; 1, mild; 2, moderate; and 3, severe.

Tear function: assessed by Schirmer’s test with anesthesia at baseline and 2 months after treatment

Ocular surface: examined with tear break-up time (TBUT) and vital dye staining with fluorescein andRose Bengal. Fluorescein staining was also rated from 0 to 3 but only on the cornea. For Rose Bengal staining the degree of staining was recorded separately for temporal and nasal conjunctiva and cornea on a scale of 0 to 3. The maximum score for each area was 3. The scores for each area were added together to obtain the total score for each eye. Therefore, the maximum score for each eye was 9. Conjunctival impression cytology and slit-lamp photography were also performed to document the change of ocular surface. 

Corrected visual acuity and slit-lamp examinations were also performed on each visit and the application of additional topical lubricants was recorded for both treatment groups.


NotesType of study (published/unpublished) and journal of publication: published in the journal Cornea 

Source of Funding: not reported 

Reported subgroup analyses: no

Study author provided additional information for assessing risk of bias not included in published report


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskInvestigators used blocks of 2 for randomization where the right eye of participant 1 was assigned to be the study eye and the fellow eye as the control eye. For participant 2, the left eye was assigned as the study eye and the fellow eye as the control. (correspondence from study investigator)

Allocation concealment (selection bias)High riskInvestigators used blocks of 2 for randomization where the right eye of participant 1 was assigned to be the study eye and the fellow eye as the control eye. For participant 2, the left eye was assigned as the study eye and the fellow eye as the control. (correspondence from study investigator)

Masking of participants of the allocated intervention (Performance bias).Low riskParticipants were masked to treatment assignment. (correspondence from study investigator)

Masking of study personnel of the allocated intervention (Performance bias)High riskThe investigator who assessed the outcomes was not masked to the treatment assignments. (correspondence from study investigator)

Masking of outcome assessors during follow-up – patient reported symptoms ( Detection bias)High riskThe investigator who assessed the outcomes was not masked to the treatment assignments. (correspondence from study investigator)

Masking of outcome assessors during follow-up – clinical examination (Detection bias)High riskThe investigator who assessed the outcomes was not masked to the treatment assignments (correspondence from study investigator). Although these were objective clinical tests, there is potential detection bias if investigators conducting the test and interpreting the results were aware of the participant's treatment assignment.

Incomplete outcome data (attrition bias)
All outcomes
Low riskStudy reported one participant who was excluded after randomization. No other missing data were reported.

Selective reporting (reporting bias)Unclear riskReported all outcomes at all time points for outcomes described in the methods, although reported information was insufficient to extract usable data for quantitative summary analysis.

Other biasUnclear riskParticipants used lubricant artificial tears as needed during the study. This may have had an effect on results.Frequency and quantity of application of the drops in each participant was unknown.

Urzua 2012

MethodsStudy design: randomized two-period cross-over trial

Unit of randomization (Individuals/Eyes): Individual (both eyes)
Unit of analysis (Individuals/Eyes): Individual

Number randomized: 12

Exclusions after randomization and reasons for exclusion: Not reported

Losses to follow-up and reasons for loss to follow-up: No loss to follow-up reported

Number analyzed: 12

Was intension-to-treat analysis performed? (Yes/No): Not reported


ParticipantsCountry: Chile

Study period: May to June 2008

Age: mean 52 (SD 6.3)

Gender: 11 women; 1 man

Underlying conditions: severe non-Sjögren dry eye

Concurrent dry eye treatments: "all had used previous treatment with artificial tears with preservative".

Inclusion criteria:

  • Age > 18 years
  • Severe Dry Eye, as defined by a OSDI score ≥ 40
  • Tear Break Up Time (TBUT) < 5 seconds
  • Cornea-conjunctival epithelial defects measured by Fluorescein staining and evaluation using the Oxford score
  • Schirmer's score less than 5 mm/5 minutes


Exclusion criteria:

  • ocular surface disease other than dry eye
  • inability to complete study protocol
  • severe anemia
  • previous use of autologous serum
  • concomitant use of other topical ocular drug (i.e. topical steroids or cyclosporine)
  • hypersensibility to any proposed interventions


Interventions1. Autologous serum - Systane

Cross-over arm starting with autologous serum for 2 weeks. After a 1-week wash-out with 0.9% sodium chloride, they continue with 2 weeks using artificial tears (Systane).

20% autologous serum solution used 4 times a day for 2 weeks. Then 0.9% sodium chloride 4 times a day for 1 week. Finally, Systane 4 times a day for 2 weeks.

2. Systane - Autologous serum

Cross-over arm starting with artificial tears (Systane) for 2 weeks. After a 1-week wash-out with 0.9% sodium chloride, they continue with 2 weeks using autologous serum.

Systane 4 times a day for 2 weeks. Then 0.9% sodium chloride used 4 times a day for 1 week. Finally, 20% autologous serum solution 4 times a day for 2 week.

Length of follow-up: 5 weeks


OutcomesPrimary Outcome Measures:

  • To compare the score reduction in the Ocular Surface Disease Index (OSDI) between participants treated with autologous serum and conventional artificial tears at 5 weeks.


Secondary Outcome Measures:

  • To compare variations in objective eye measurements, such as Tear Break Up Time (in seconds), corneal-conjunctival staining according to the Oxford Score (6 categories), and best-corrected visual acuity in participants treated with autologous serum and conventional artificial tears at 5 weeks


NotesType of study (published/unpublished) and journal of publication: published in the journal Current Eye Research

Source of funding: Not reported

Reported subgroup analyses: No

ClinicalTrials.gov Identifier: NCT00779987


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Using random number tables method, a random treatment assignment code was created and every patient was given a sealed opaque envelope with the secret code."

Allocation concealment (selection bias)Low risk"Using random number tables method, a random treatment assignment code was created and every patient was given a sealed opaque envelope with the secret code. Then, the patient handed the envelope to the Cell Therapy Laboratory operator who delivered the treatment set."

Masking of participants of the allocated intervention (Performance bias).Low risk"Both groups of treatment were given a set of 14 identical, opaque flasks (containing either AS or artificial tears) with instructions of keeping them frozen at -20°C."

Masking of study personnel of the allocated intervention (Performance bias)Low risk"Both DES patient groups, clinical evaluators, and data analyst were masked to group intervention assignment through the whole completion of the protocol (double-masked design)."

Masking of outcome assessors during follow-up – patient reported symptoms ( Detection bias)Low risk"Both DES patient groups, clinical evaluators, and data analyst were masked to group intervention assignment through the whole completion of the protocol (double-masked design)."

"Clinical evaluation of each patient (OSDI, BCVA, TBUT,and OXFORD) was assessed at baseline, beginning and end of treatment by two researchers (Cristhian A. Urzua and Dario H. Vasquez) in a masked way."

Masking of outcome assessors during follow-up – clinical examination (Detection bias)Low risk"Both DES patient groups, clinical evaluators, and data analyst were masked to group intervention assignment through the whole completion of the protocol (double-masked design)."

"Clinical evaluation of each patient (OSDI, BVCA, TBUT,and OXFORD) was assessed at baseline, beginning and end of treatment by two researchers (Cristhian A. Urzua and Dario H. Vasquez) in a masked way."

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo loss to follow-up reported

Selective reporting (reporting bias)Low riskReported data for all outcomes described in CT.gov record: NCT00779987

Other biasUnclear riskDifferences in eligibility criteria between the CT.gov record and published report including non-Sjogrens syndrome and Shrimer’s score < 5 mm/5 min.

We felt the cross-over design was appropriate given the relative stability of dry eye eliminating the potential for a temporal treatment effect and that there was clearly a random order in which participants received their treatments. The use of a 1-week wash-out between treatment periods ensured there was no carry-over effect from one treatment period to the next. Although the study report described paired analyses to take advantage of the within-participant design, the outcome data were reported according to treatment group and thus we were not able to extract the paired data.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Albegger 1972Not a randomized controlled trial

Alvarado 2004Non-randomized case-series

Anderson 2004Non-randomized case-series

Badami 2009Non-randomized case-series

Bradley 2008Non-randomized case series

Brown 2005Non-randomized case-series

Chiang 2007Non-randomized case-series

Craig 2008Non-randomized case-series

Fuchsluger 2005Non-randomized case report

Geerling 2002This is an overview about efficacy and recommendations for autologous serum for dry eye disease. It is not a randomized controlled trial.

Geerling 2004Non-randomized case-series

Geerling 2008This is a review of autologous blood products in the treatment of dry eye, it is not a randomized controlled trial.

Harritshoj 2011Retrospective study investigating allogenic (donor) serum

Hyon 2007Retrospective study

Jaksche 2005Randomized trial comparing 50% autologous serum drops with 100% autologous serum drops

Koffler 2006Non-randomized case-series

Kojima 2005bNon-randomized case-series

Kojima 2008Non-randomized case-series

Messmer 2005Not a randomized controlled trial.

Movahedan 2006Non-randomized case-series

Noble 2004Conventional treatment arm included different pharmacological agents for each participant

Ogawa 2003Non-randomized case-series

Poon 2001Non-randomized case-series

Watson 2010Non-randomized case-series

Yoon 2007Comparison group 'Umbilical cord serum' did not meet the criteria for our included studies. No publication found.

 
Comparison 1. Autologous serum (20%) versus artificial tears

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Participant-reported symptoms (severe dry eye)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Change from baseline at two weeks follow-up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Rose Bengal (severe dry eye)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 Change from baseline at two weeks follow-up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Rose Bengal (post-LASIK dry eye)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 Mean at one month follow-up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 Mean at three months follow-up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Fluorescein (severe dry eye)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Change from baseline at two weeks follow up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Schirmers I test (severe dry eye)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    5.1 Two weeks follow-up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 TBUT (severe dry eye)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    6.1 Change from baseline at two weeks follow-up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 TBUT (post-LASIK dry eye)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 Six months follow-up
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 2. Autologous serum (20%) versus saline solution

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Participant-reported symptoms (severe dry eye)Other dataNo numeric data

    1.1 One month follow-up
Other dataNo numeric data

    1.2 Two months follow-up
Other dataNo numeric data

 2 Rose Bengal (severe dry eye)Other dataNo numeric data

    2.1 One week follow-up
Other dataNo numeric data

    2.2 One month follow-up
Other dataNo numeric data

    2.3 Two months follow-up
Other dataNo numeric data

 3 Fluorescein (severe dry eye)Other dataNo numeric data

    3.1 One week follow-up
Other dataNo numeric data

    3.2 One month follow-up
Other dataNo numeric data

    3.3 Two months follow-up
Other dataNo numeric data

 4 Schirmers I test (with anesthesia) (severe dry eye)Other dataNo numeric data

    4.1 Two months follow-up
Other dataNo numeric data

 5 TBUT (severe dry eye)Other dataNo numeric data

    5.1 One week follow-up
Other dataNo numeric data

    5.2 One month follow-up
Other dataNo numeric data

    5.3 Two months follow-up
Other dataNo numeric data

 
Analysis 2.1 Comparison 2 Autologous serum (20%) versus saline solution, Outcome 1 Participant-reported symptoms (severe dry eye).
Participant-reported symptoms (severe dry eye)

StudyTotal participantsMean (AS 20%)SD (AS 20%)Mean (control)SD (control)

One month follow-up

Tananuvat 2001125.36Not reported6.45Not reported

Two months follow-up

Tananuvat 2001125.3Not reported5.9Not reported

 
Analysis 2.2 Comparison 2 Autologous serum (20%) versus saline solution, Outcome 2 Rose Bengal (severe dry eye).
Rose Bengal (severe dry eye)

StudyTotal participantsMean (AS 20%)SD (AS 20%)Mean (control)SD (control)

One week follow-up

Tananuvat 2001123Not reported3.67Not reported

One month follow-up

Tananuvat 2001124.22Not reported4.22Not reported

Two months follow-up

Tananuvat 2001123.7Not reported3.8Not reported

 
Analysis 2.3 Comparison 2 Autologous serum (20%) versus saline solution, Outcome 3 Fluorescein (severe dry eye).
Fluorescein (severe dry eye)

StudyTotal participantsMean (AS 20%)SD (AS 20%)Mean (control)SD (control)

One week follow-up

Tananuvat 2001121.6Not reported1.7Not reported

One month follow-up

Tananuvat 2001121.55Not reported1.55Not reported

Two months follow-up

Tananuvat 2001121.33Not reported1.42Not reported

 
Analysis 2.4 Comparison 2 Autologous serum (20%) versus saline solution, Outcome 4 Schirmers I test (with anesthesia) (severe dry eye).
Schirmers I test (with anesthesia) (severe dry eye)

StudyTotal participantsMean (AS 20%)SD (AS 20%)Mean (control)SD (control)

Two months follow-up

Tananuvat 2001122.83Not reported3.25Not reported

 
Analysis 2.5 Comparison 2 Autologous serum (20%) versus saline solution, Outcome 5 TBUT (severe dry eye).
TBUT (severe dry eye)

StudyTotal participantsMean (AS 20%)SD (AS 20%)Mean (control)SD (control)

One week follow-up

Tananuvat 2001120.8Not reported0.7Not reported

One month follow-up

Tananuvat 2001120.55Not reported0.64Not reported

Two months follow-up

Tananuvat 2001120.83Not reported1.17Not reported