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

Corneal Epithelial Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01168375
• Other study ID #: 8742
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 1, 2010
• Last updated: July 22, 2010

Study information

• Verified date: March 2010
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Corneal Epithelial Defect

Intervention

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
• conventional therapy
chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences	Ophthalmic Research Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of corneal epithelial defect	measurement of corneal epithelial defect in days 3,5,7,12 by slit lamp		Yes