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

Phase 1

• Conditions: Corneal Epithelial Defect
• Interventions: Drug: conventional therapy; Drug: conventional therapy plus umbilical cord serum eye drop

• Registration Number: NCT01168375
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-22
• Last Update Submitted: 2010-07-22
• Study First Posted: 2010-07-23
• Last Update Posted: 2010-07-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
conventional therapy	conventional therapy	chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours
conventional therapy plus umbilical cord serum eye drop	conventional therapy plus umbilical cord serum eye drop	-

Primary Outcome Measures

Name	Time	Method
measurement of corneal epithelial defect		measurement of corneal epithelial defect in days 3,5,7,12 by slit lamp

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of