Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects

Not Applicable

Completed

• Conditions: Corneal Diseases
• Interventions: Drug: Continuous use of topical autologous serum

• Registration Number: NCT02291731
• Lead Sponsor: E-DA Hospital

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 Description

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patients with PEDs for more than 1-month following conventional treatment, visiting E-Da Hospital, Kaohsiung, Taiwan.

Exclusion Criteria

• Patients had dry eye syndrome with a Schirmer test (<10 mm in 5 minutes) or lid abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous use of autologous serum	Continuous use of topical autologous serum	with continuous use of topical autologous serum for an additional 2 weeks after total re-epithelialization.

Primary Outcome Measures

Name	Time	Method
epithelial defect healing rate	2-week

Secondary Outcome Measures

Name	Time	Method
epithelial defect recurrence rate	3-month

Trial Locations

Locations (1)

E-DA hospital; 🇨🇳 Kaohsiung, Taiwan