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Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects

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ClinicalTrials.gov Identifier: NCT02291731
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Corneal Diseases Drug: Continuous use of topical autologous serum Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Topical Autologous Serum Eye Drops Combined With Silicone Hydrogen Lenses for theTreatment of Corneal Epithelial Defects
Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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 Name: autologous serum eye drops




Primary Outcome Measures :
  1. epithelial defect healing rate [ Time Frame: 2-week ]

Secondary Outcome Measures :
  1. epithelial defect recurrence rate [ Time Frame: 3-month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291731


Locations
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Taiwan
E-DA hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
E-DA Hospital
Investigators
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Study Chair: Yan-Ming Chen, M.D. Department of Ophthalmology, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan
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Responsible Party: E-DA Hospital
ClinicalTrials.gov Identifier: NCT02291731    
Other Study ID Numbers: EMRP37103N
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by E-DA Hospital:
Autologous serum eye drops
Silicone-hydrogel contact lens
Persistent epithelial defects
Corneal epithelial defects
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions