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

September 7, 2010 updated by: National Taiwan University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10047
        • National Taiwan University Hospital, department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every day till total re-epithelization up to 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
every day till total re-epithelization up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 7, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200701021R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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