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

NCT01168375 | Unknown Phase 1

• 1 other identifier: 8742
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Epithelial Defect

Outcome Measures

Primary Outcomes (1)

• measurement of corneal epithelial defect

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

Study Arms (2)

conventional therapy

ACTIVE COMPARATOR

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

Drug: conventional therapy

conventional therapy plus umbilical cord serum eye drop

ACTIVE COMPARATOR

Drug: conventional therapy plus umbilical cord serum eye drop

Interventions

conventional therapy plus umbilical cord serum eye drop DRUG

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 plus umbilical cord serum eye drop

conventional therapy DRUG

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

conventional therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead
• Ophthalmic Research Center: collaborator

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 166666, Iran

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 23, 2010
• Last Updated: July 23, 2010

Record last verified: 2010-03

Locations

IR (1)