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OpenTrials
Completed

NCT Number: NCT00238862

Treatment of PED With AMT and Autologous Serum

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.

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Key information

Conditions

Corneal Epithelial Defect Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Khaled Eye Specialist Hospital

Riyadh, 11462, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amniotic membrane transplantation

Procedure

Autologous serum/BSS 20%

Drug

Primary outcomes

  1. Corneal re-epithelialization (= initial success)

  2. Persistent corneal re-epithelialization (= lasting success)

Sponsors and collaborators

Lead sponsor

King Khaled Eye Specialist Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Oct 14, 2005
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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