Clinical Trial: Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Topical Autologous Serum Eye Drops Combined With Silicone Hydrogen Lenses for theTreatment of Corneal Epithelial Defects

Brief Summary: To evaluate the clinical effect of combination of topical 20% (v/v) autologous serum eye drops and a silicone-hydrogel contact lens (CLs) in the treatment of recalcitrant persistent epithelial defects (PEDs) and the recurrence rate of epithelial breakdown with or without continued use of autologous serum eye drops.

Detailed Summary: Dealing with persistent epithelial defects (PEDs) of the cornea is a challenge for ophthalmologists, and surgical intervention is occasionally indicated for the management of recalcitrant cases that are unresponsive to medical therapy. Bandage contact lenses (BCLs), especially silicone-hydrogel CLs with high oxygen permeability and transmissibility, are useful for treating PEDs. Over the past several years, autologous serum eye drops (ASEs) are gaining popular and widespread acceptance as adjuvant therapy for various ocular surface disorders, including PEDs recalcitrant to standard medical therapies.The combination of BCLs and ASEs for PEDs treatment have also been reported with satisfactory results in a few small series' of PED patients. In this study, we will conduct a prospective interventional study to investigate the therapeutic effects of the combination of topical 20% ASEs and silicone-hydrogel CLs for recalcitrant PEDs, as well as to compare the recurrence of epithelial breakdown with or without continuous usage of autologous serum eye drops after CL removal. Patients with PEDs for more than 4 weeks without improvement despite previous conventional treatment were treated. Silicone-hydrogel SCLs combined with 20% (v/v) autologous serum eye drops were used until complete re-epithelialization. SCLs were removed after total re-epithelialization and patients were subsequently randomized divided into two groups: (1) with and (2) without continuous use of topical autologous serum for an additional 2 weeks. PED healing rate and epithelial defect recurrence during a 3-month follow-up were evaluated.
Sponsor: E-DA Hospital

Current Primary Outcome: epithelial defect healing rate [ Time Frame: 2-week ]

Original Primary Outcome: Same as current

Current Secondary Outcome: epithelial defect recurrence rate [ Time Frame: 3-month ]

Original Secondary Outcome: Same as current

Information By: E-DA Hospital

Dates:
Date Received: November 7, 2014
Date Started: September 2014
Date Completion:
Last Updated: September 16, 2015
Last Verified: September 2015