Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
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| ClinicalTrials.gov Identifier: NCT01075347 |
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Recruitment Status :
Completed
First Posted : February 25, 2010
Results First Posted : September 2, 2010
Last Update Posted : September 14, 2010
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Sponsor:
National Taiwan University Hospital
Information provided by:
National Taiwan University Hospital
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment |
| Conditions |
Corneal Epithelial Defect Diabetic Retinopathy Penetrating Keratoplasty |
| Interventions |
Other: autologous serum Other: Non-autologous serum |
| Enrollment | 165 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Autologous Serum Use | Non-autologous Serum Use |
|---|---|---|
 Arm/Group Description |
Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty | Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty |
| Period Title: Overall Study | ||
| Started | 82 | 83 |
| Completed | 82 | 83 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Autologous Serum Use | Non-autologous Serum Use | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty | Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty | Total of all reporting groups | |
| Overall Number of Baseline Participants | 82 | 83 | 165 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 82 participants | 83 participants | 165 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
42 51.2%
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45 54.2%
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87 52.7%
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| >=65 years |
40 48.8%
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38 45.8%
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78 47.3%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 82 participants | 83 participants | 165 participants | |
| 60.8 (18.1) | 59.8 (17.6) | 60.3 (19.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 82 participants | 83 participants | 165 participants | |
| Female |
44 53.7%
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42 50.6%
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86 52.1%
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| Male |
38 46.3%
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41 49.4%
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79 47.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| Taiwan | Number Analyzed | 82 participants | 83 participants | 165 participants |
| 82 | 83 | 165 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | We-Li Chen , MD |
| Organization: | Natinal Taiwan University Hospital |
| Phone: | 886-2-2356 ext 5206 |
| EMail: | chenweili@ntu.edu.tw |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | We-Li Chen , MD, Natinal Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01075347 |
| Other Study ID Numbers: |
200701021R |
| First Submitted: | December 4, 2008 |
| First Posted: | February 25, 2010 |
| Results First Submitted: | July 14, 2010 |
| Results First Posted: | September 2, 2010 |
| Last Update Posted: | September 14, 2010 |