CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 165 enrolled
Drug / intervention
autologous serum +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01075347
NCT01075347Phase 1Completed

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

National Taiwan University Hospital·interventional·Posted Feb 25, 2010·Updated Sep 14, 2010

In Brief

A Phase 1 clinical trial evaluating autologous serum and Non-autologous serum for Corneal Epithelial Defect and 2 related conditions. Completed, enrolled 165 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2010
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.4 years ago

Interventions

autologous serumother

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

Non-autologous serumother

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