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

NCT ID: NCT01168375

Last Updated: 2010-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Corneal Epithelial Defect

Study Groups

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conventional therapy

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

Group Type ACTIVE_COMPARATOR

conventional therapy

Intervention Type DRUG

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

conventional therapy plus umbilical cord serum eye drop

Group Type ACTIVE_COMPARATOR

conventional therapy plus umbilical cord serum eye drop

Intervention Type 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

Interventions

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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

Intervention Type DRUG

conventional therapy

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ophthalmic Research Center

AMBIG

Sponsor Role collaborator

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ophthalmic Research Center

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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8742

Identifier Type: -

Identifier Source: org_study_id

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