Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial

Status Completed

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Corneal Diseases

Clinical Trial Details

NCT number	NCT02291731
Study type	Interventional
Source	E-DA Hospital
Contact
Status	Completed
Phase	N/A
Start date	September 2014
Completion date	August 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00810472` - Functional Antigen Matching in Corneal Transplantation	N/A
Completed	`NCT00029185` - Study of Dehydrex in Patients With Corneal Erosion	N/A
Enrolling by invitation	`NCT03436576` - Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye	Phase 3
Completed	`NCT02344732` - Effect of Systemic Oxygen on Corneal Epithelial Wound Healing in Diabetic Patients Undergoing Pars Plana Vitrectomy	N/A
Recruiting	`NCT06451172` - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis	Early Phase 1
Not yet recruiting	`NCT05833737` - Corneal Findings in Patients Treated With Belantamab Mafodotin
Completed	`NCT04421300` - A Randomized Study of Smile Exercise for Dry Eye	N/A
Completed	`NCT00396188` - Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions	Phase 1
Terminated	`NCT03029104` - Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas	Phase 2
Completed	`NCT02348242` - Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches	N/A
Completed	`NCT00050466` - Dynamic Light Scattering and Keratoscopy for Corneal Examination	N/A
Recruiting	`NCT04164407` - Keratoconus, Corneal Diseases and Transplant Registry
Withdrawn	`NCT05052554` - Study With QR-504a to Evaluate Safety, Tolerability & Corneal Endothelium Molecular Biomarker(s) in Subjects With FECD3	Phase 1
Terminated	`NCT00447187` - Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk	Phase 3
Completed	`NCT00491439` - Using in Vivo Confocal Microscope to Evaluate the Corneal Wound Healing After Various Ocular Surgeries	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Autologous Serum Eye Drops With Contact Lenses for Corneal Epithelial Defects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms