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

Primary Purpose

Corneal Epithelial Defect, Diabetic Retinopathy, Penetrating Keratoplasty

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
autologous serum
Non-autologous serum
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Epithelial Defect focused on measuring autoserum, ocular surgery, corneal epithelium healing

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University Hospital, department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Autologous serum use

Non-autologous serum use

Arm Description

Patients treated with additional 20% autoserum after diabetic vitrectomy or penetrating keratoplasty

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

Outcomes

Primary Outcome Measures

Patients With Corneal Epithelial Healing Time Within 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

Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)

Full Information

First Posted
December 4, 2008
Last Updated
September 7, 2010
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01075347
Brief Title
Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
Official Title
Clinical Study: Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Epithelial Defect, Diabetic Retinopathy, Penetrating Keratoplasty
Keywords
autoserum, ocular surgery, corneal epithelium healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous serum use
Arm Type
Active Comparator
Arm Description
Patients treated with additional 20% autoserum after diabetic vitrectomy or penetrating keratoplasty
Arm Title
Non-autologous serum use
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
autologous serum
Other Intervention Name(s)
Autoserum
Intervention Description
with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
Intervention Type
Other
Intervention Name(s)
Non-autologous serum
Intervention Description
without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
Primary Outcome Measure Information:
Title
Patients With Corneal Epithelial Healing Time Within 14 Days
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Li Chen, MD, PhD
Organizational Affiliation
National Taiwan University Hospital, department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital, department of Ophthalmology
City
Taipei
ZIP/Postal Code
10047
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20579630
Citation
Chen YM, Hu FR, Huang JY, Shen EP, Tsai TY, Chen WL. The effect of topical autologous serum on graft re-epithelialization after penetrating keratoplasty. Am J Ophthalmol. 2010 Sep;150(3):352-359.e2. doi: 10.1016/j.ajo.2010.03.024. Epub 2010 Jun 25.
Results Reference
derived

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

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