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Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

NCT01075347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2010-09-14

Study results available
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Summary

Ophthalmology ,cornea Autologous serum has long been known to be effective to promote corneal epithelial wound healing in a variety of ocular surface disorders. However, its effectiveness for corneal epithelial defects due to pars plana vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty has seldom been reported. In this study, we plan to perform a prospective study to determine the effectiveness of topical autologous serum as a primary treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and penetrating keratoplasty. All patients enrolled in this study have received corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic retinopathy and penetrating keratoplasty. The patients were grouped into two treatment groups. In the control group, the patients receive conventional postoperative eye drops including topical steroid, antibiotic and mydriatics. In the experimental group, the patients receive topical autologous serum eye drops in addition to conventional postoperative eye drops. The duration for cornea surface to completely re-epithelize, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of recurrent epithelial break down after initial epithelization will be compared between these two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty will be compared separately

Conditions

Interventions

OTHER

autologous serum

with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours

OTHER

Non-autologous serum

without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Wei-Li Chen, MD, PhD · National Taiwan University Hospital, department of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01075347 on ClinicalTrials.gov