Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects

Sponsor

E-DA Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02291731

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Diseases	Drug: Continuous use of topical autologous serum	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

epithelial defect healing rate [2-week]

Secondary Outcome Measures

epithelial defect recurrence rate [3-month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	E-DA hospital	Kaohsiung		Taiwan

Sponsors and Collaborators

E-DA Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

E-DA Hospital

ClinicalTrials.gov Identifier:

NCT02291731

Other Study ID Numbers:

EMRP37103N

First Posted:

Nov 14, 2014

Last Update Posted:

Sep 17, 2015

Last Verified:

Sep 1, 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:

Corneal Diseases

Ophthalmic Solutions

Study Results

No Results Posted as of Sep 17, 2015