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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Description
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Brief Summary:
Ophthalmology ,cornea Autologous serum has long been known to be effective to promote corneal epithelial wound healing in a variety of ocular surface disorders. However, its effectiveness for corneal epithelial defects due to pars plana vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty has seldom been reported. In this study, we plan to perform a prospective study to determine the effectiveness of topical autologous serum as a primary treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and penetrating keratoplasty. All patients enrolled in this study have received corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic retinopathy and penetrating keratoplasty. The patients were grouped into two treatment groups. In the control group, the patients receive conventional postoperative eye drops including topical steroid, antibiotic and mydriatics. In the experimental group, the patients receive topical autologous serum eye drops in addition to conventional postoperative eye drops. The duration for cornea surface to completely re-epithelize, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of recurrent epithelial break down after initial epithelization will be compared between these two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty will be compared separately

Condition or disease Intervention/treatment Phase
Corneal Epithelial Defect Diabetic Retinopathy Penetrating Keratoplasty Other: autologous serum Other: Non-autologous serum Phase 1

Detailed Description:
Purpose: To evaluate the treatment effect of autologous serum eye drops for promoting corneal epithelium wound healing in patients receiving pars plana vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty. Background: During PPV for diabetic retinopathy retinopathy and penetrating keratoplasty, removal of the edematous corneal epithelial layer was usually required in order to obtain a better surgical view or enhance the postoperative epithelial wound healing process. However, delayed epithelial healing was frequently found in these patients after surgeries. In addition, corneal epithelial defect is also frequent found in diabetic patients after PPV even corneal epithelial debridement is not performed during the operation. Autologous serum, the fluid component of full blood after blood clotting, contains a large variety of growth factors, vitamins, and immunoglobulins. These epitheliotropic factors are thought to be responsible for the therapeutic effect of serum observed on ocular surface disorders. The effects of serum to promote epithelial wound healing have been well documented in cell culture system in a variety of epithelial cell types including corneal epithelial cells. Autologous serum eye drops have also been demonstrated to be beneficial in the treatment of persistent corneal epithelial defects. In this study, we planned a prospective study to determine the effectiveness of autologous serum tears as a primary treatment in corneal epithelial defect following vitrectomy in diabetic patients and penetrating keratoplasty.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Study: Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
Study Start Date : March 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Autologous serum use
Patients treated with additional 20% autoserum after diabetic vitrectomy or penetrating keratoplasty
 Other: autologous serum
with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
Other Name: Autoserum
Placebo Comparator: Non-autologous serum use
Patients treated with traditional medication(0.1% betamethasone, 0.3% gentamicin and 0.4% tropicamide eye drops application 4 times daily) after diabetic vitrectomy or penetrating keratoplasty
 Other: Non-autologous serum
without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours


Outcome Measures
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Primary Outcome Measures :
  1. Patients With Corneal Epithelial Healing Time Within 14 Days [ Time Frame: every day till total re-epithelization up to 14 days ]
    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.


Secondary Outcome Measures :
  1. Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization) [ Time Frame: every day till total re-epithelization up to 14 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with proliferative diabetic retinopathy who's condition need to receive pars plana vitrectomy or patients who need to receive penetrating keratoplasty

Exclusion Criteria:

  • For PPV: ocular disease such as limbal stem cell Insufficiency , glaucoma, lagophthalmos
  • For penetrating keratoplasty:ocular or systemic disease that would affect epithelial healing, such as severe dry eye, severe lid abnormalities, limbal stem cell deficiency, or corneal anesthesia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075347


Locations
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Taiwan
National Taiwan University Hospital, department of Ophthalmology
Taipei, Taiwan, 10047
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wei-Li Chen, MD, PhD National Taiwan University Hospital, department of Ophthalmology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: We-Li Chen , MD, Natinal Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01075347    
Other Study ID Numbers: 200701021R
First Posted: February 25, 2010    Key Record Dates
Results First Posted: September 2, 2010
Last Update Posted: September 14, 2010
Last Verified: September 2010
Keywords provided by National Taiwan University Hospital:
autoserum
ocular surgery
corneal epithelium healing
Additional relevant MeSH terms:
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Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases