Phase 1 N=165 Randomized Single-blind Treatment

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

Corneal Epithelial Defect · Diabetic Retinopathy · Penetrating Keratoplasty

Bottom Line

View on ClinicalTrials.gov: NCT01075347 ↗

Enrolled (actual)

165

Serious AEs

0.0%

Results posted

Sep 2010

Primary outcome: Primary: Patients With Corneal Epithelial Healing Time Within 14 Days — 78; 73 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: autologous serum (Other); Non-autologous serum (Other)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: National Taiwan University Hospital
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients With Corneal Epithelial Healing Time Within 14 Days	78; 73	—
SECONDARY Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)	0; 0	—

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

Eligibility Criteria

Inclusion Criteria

patients with proliferative diabetic retinopathy who's condition need to receive pars plana vitrectomy or patients who need to receive penetrating keratoplasty

Exclusion Criteria

For PPV: ocular disease such as limbal stem cell Insufficiency , glaucoma, lagophthalmos
For penetrating keratoplasty: ocular or systemic disease that would affect epithelial healing, such as severe dry eye, severe lid abnormalities, limbal stem cell deficiency, or corneal anesthesia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01075347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.