The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy

July 22, 2010 updated by: Shahid Beheshti University of Medical Sciences
80 diabetic patients underwent vitrectomy and had no history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune deficiency will be randomized into two groups (double blind)to evaluate the role of umbilical cord serum therapy on improvement of corneal epithelial defect following diabetic vitrectomy. Both groups will take the conventional medication including Chloramphenicol, Betamethasone, Cycloplegic eye drops besides the case group will take umbilical cord serum eye drop in the eye operated. After surgery the corneal epithelial defect will be measured by slit lamp.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic patients with corneal epithelial defect following diabetic vitrectomy at labbafinejad Hospital

Exclusion Criteria:

  • Any history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune deficiency
  • Patients with one eye
  • Use of any eye drops except Chloramphenicol, Betamethasone, Cycloplegic and contact lens for corneal epithelial defect

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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional therapy
chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours
Drug: conventional therapy
chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours
ACTIVE_COMPARATOR: conventional therapy plus umbilical cord serum eye drop
Drug: conventional therapy plus umbilical cord serum eye drop
chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours plus umbilical cord serum eye drop 20% every 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
measurement of corneal epithelial defect
measurement of corneal epithelial defect in days 3,5,7,12 by slit lamp

Collaborators and Investigators

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

Sponsor

Shahid Beheshti University of Medical Sciences

Collaborators

Ophthalmic Research Center

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 Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (ESTIMATE)

July 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8742

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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Locations

3
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