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Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

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ClinicalTrials.gov Identifier: NCT01075347
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : September 2, 2010
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autologous Serum Use Non-autologous Serum Use
Hide 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
Arm/Group Title Autologous Serum Use Non-autologous Serum Use Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 83 participants 165 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
  51.2%
45
  54.2%
87
  52.7%
>=65 years
40
  48.8%
38
  45.8%
78
  47.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 83 participants 165 participants
60.8  (18.1) 59.8  (17.6) 60.3  (19.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 83 participants 165 participants
Female
44
  53.7%
42
  50.6%
86
  52.1%
Male
38
  46.3%
41
  49.4%
79
  47.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 82 participants 83 participants 165 participants
82 83 165
1.Primary Outcome
Title Patients With Corneal Epithelial Healing Time Within 14 Days
Hide Description Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for >14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients.
Time Frame every day till total re-epithelization up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous Serum Use Non-autologous Serum Use
Hide Arm/Group Description:
Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Overall Number of Participants Analyzed 82 83
Measure Type: Number
Unit of Measure: participants
78 73
2.Secondary Outcome
Title Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)
Hide Description [Not Specified]
Time Frame every day till total re-epithelization up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous Serum Use Non-autologous Serum Use
Hide Arm/Group Description:
Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Overall Number of Participants Analyzed 82 83
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autologous Serum Use Non-autologous Serum Use
Hide Arm/Group Description Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
All-Cause Mortality
Autologous Serum Use Non-autologous Serum Use
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Autologous Serum Use Non-autologous Serum Use
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/83 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autologous Serum Use Non-autologous Serum Use
Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)   0/83 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: We-Li Chen , MD
Organization: Natinal Taiwan University Hospital
Phone: 886-2-2356 ext 5206
Responsible Party: We-Li Chen , MD, Natinal Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01075347     History of Changes
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