Back to resultsAutologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects
Primary Purpose
Corneal Diseases
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Continuous use of topical autologous serum
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Diseases focused on measuring Autologous serum eye drops, Silicone-hydrogel contact lens, Persistent epithelial defects, Corneal epithelial defects
Eligibility Criteria
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.
Sites / Locations
- E-DA hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Continuous use of autologous serum
Arm Description
with continuous use of topical autologous serum for an additional 2 weeks after total re-epithelialization.
Outcomes
Primary Outcome Measures
epithelial defect healing rate
Secondary Outcome Measures
epithelial defect recurrence rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02291731
Brief Title
Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects
Official Title
Topical Autologous Serum Eye Drops Combined With Silicone Hydrogen Lenses for theTreatment of Corneal Epithelial Defects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
E-DA Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Diseases
Keywords
Autologous serum eye drops, Silicone-hydrogel contact lens, Persistent epithelial defects, Corneal epithelial defects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous use of autologous serum
Arm Type
Experimental
Arm Description
with continuous use of topical autologous serum for an additional 2 weeks after total re-epithelialization.
Intervention Type
Drug
Intervention Name(s)
Continuous use of topical autologous serum
Other Intervention Name(s)
autologous serum eye drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
epithelial defect healing rate
Time Frame
2-week
Secondary Outcome Measure Information:
Title
epithelial defect recurrence rate
Time Frame
3-month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan-Ming Chen, M.D.
Organizational Affiliation
Department of Ophthalmology, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
E-DA hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
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Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects
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