Clinical trial NCT02291731: 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
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Diseases
Keywords: Autologous serum eye drops
Silicone-hydrogel contact lens
Persistent epithelial defects
Corneal epithelial defects
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: epithelial defect healing rate
timeFrame: 2-week
Secondary outcomes:
measure: epithelial defect recurrence rate
timeFrame: 3-month
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA hospital
Study officials:
affiliation: Department of Ophthalmology, E-Da Hospital, I-Shou University, Kaohsiung, Taiwan
name: Yan-Ming Chen, M.D.
role: STUDY_CHAIR
References: