Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects

September 16, 2015 updated by: E-DA Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • E-DA hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous use of autologous serum
with continuous use of topical autologous serum for an additional 2 weeks after total re-epithelialization.
Drug: Continuous use of topical autologous serum
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 after SCLs removal.
Other Names:
  • autologous serum eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
epithelial defect healing rate
Time Frame: 2-week
2-week

Secondary Outcome Measures

Outcome Measure
Time Frame
epithelial defect recurrence rate
Time Frame: 3-month
3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

E-DA Hospital

Investigators

  • Study Chair: Yan-Ming Chen, M.D., Department of Ophthalmology, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMRP37103N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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