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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Shaheed Beheshti Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ophthalmic Research Center
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01168375
First received: July 1, 2010
Last updated: July 22, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention Phase
Corneal Epithelial Defect
 Drug: conventional therapy plus umbilical cord serum eye drop
Drug: conventional therapy
 Phase 1

Study Type: Interventional
Official Title: The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • measurement of corneal epithelial defect [ Designated as safety issue: Yes ]
    measurement of corneal epithelial defect in days 3,5,7,12 by slit lamp


Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168375

Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 166666
Sponsors and Collaborators
Shaheed Beheshti Medical University
Ophthalmic Research Center
  More Information

No publications provided

Responsible Party: Ophthalmic Research Center
ClinicalTrials.gov Identifier: NCT01168375     History of Changes
Other Study ID Numbers: 8742
Study First Received: July 1, 2010
Last Updated: July 22, 2010
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Betamethasone
Tetrahydrozoline
Chloramphenicol
Mydriatics
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013