Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01168375
Recruitment Status : Unknown
Verified March 2010 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2010
Last Update Posted : July 23, 2010
Sponsor:
Collaborator:
Ophthalmic Research Center
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Corneal Epithelial Defect Drug: conventional therapy plus umbilical cord serum eye drop Drug: conventional therapy Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Official Title: The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. measurement of corneal epithelial defect
    measurement of corneal epithelial defect in days 3,5,7,12 by slit lamp



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01168375


Locations
Layout table for location information
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 166666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Ophthalmic Research Center
Layout table for additonal information
Responsible Party: Ophthalmic Research Center
ClinicalTrials.gov Identifier: NCT01168375    
Other Study ID Numbers: 8742
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Ophthalmic Solutions
Pharmaceutical Solutions