Treatment of PED With AMT and Autologous Serum

Corneal Epithelial Defect Clinical Trial

Official title:

Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238862
• Other study ID #: RP0511-P
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: September 2006

Study information

• Verified date: November 2021
• Source: King Khaled Eye Specialist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Corneal epithelial defect of more than 14 days that has not responded to conventional therapy

Exclusion Criteria:

• Under age 18

• Pregnant/lactating females

• Patients with hemoglobin levels < 12 mg/ml

• Patients with limbal stem cell deficiency

Related Conditions & MeSH terms

• Corneal Epithelial Defect

Intervention

Procedure:
• Amniotic membrane transplantation

Drug:
• Autologous serum/BSS 20%

Locations

Country	Name	City	State
Saudi Arabia	King Khaled Eye Specialist Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Khaled Eye Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal re-epithelialization (= initial success)
Primary	Persistent corneal re-epithelialization (= lasting success)