Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

NCT01075347 | Completed Phase 1 Results

• 1 other identifier: 200701021R
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Ophthalmology ,cornea Autologous serum has long been known to be effective to promote corneal epithelial wound healing in a variety of ocular surface disorders. However, its effectiveness for corneal epithelial defects due to pars plana vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty has seldom been reported. In this study, we plan to perform a prospective study to determine the effectiveness of topical autologous serum as a primary treatment for corneal epithelial defect in patients undergoing vitrectomy for diabetic retinopathy and penetrating keratoplasty. All patients enrolled in this study have received corneal epithelial debridement at the end of the ocular surgeries, namely PPV for diabetic retinopathy and penetrating keratoplasty. The patients were grouped into two treatment groups. In the control group, the patients receive conventional postoperative eye drops including topical steroid, antibiotic and mydriatics. In the experimental group, the patients receive topical autologous serum eye drops in addition to conventional postoperative eye drops. The duration for cornea surface to completely re-epithelize, the incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization), and the incidence of recurrent epithelial break down after initial epithelization will be compared between these two groups. Patients undergoing PPV for diabetic retinopathy and penetrating keratoplasty will be compared separately

Conditions

Corneal Epithelial Defect; Diabetic Retinopathy; Penetrating Keratoplasty

Keywords

autoserum; ocular surgery; corneal epithelium healing

Outcome Measures

Primary Outcomes (1)

• Patients With Corneal Epithelial Healing Time Within 14 Days

  Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for \>14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients.

  every day till total re-epithelization up to 14 days

Secondary Outcomes (1)

• Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)

  every day till total re-epithelization up to 14 days

Study Arms (2)

Autologous serum use

ACTIVE COMPARATOR

Patients treated with additional 20% autoserum after diabetic vitrectomy or penetrating keratoplasty

Other: autologous serum

Non-autologous serum use

PLACEBO COMPARATOR

Patients treated with traditional medication(0.1% betamethasone, 0.3% gentamicin and 0.4% tropicamide eye drops application 4 times daily) after diabetic vitrectomy or penetrating keratoplasty

Other: Non-autologous serum

Interventions

autologous serum OTHER

with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours

Also known as: Autoserum

Autologous serum use

Non-autologous serum OTHER

without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours

Non-autologous serum use

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with proliferative diabetic retinopathy who's condition need to receive pars plana vitrectomy or patients who need to receive penetrating keratoplasty

You may not qualify if:

• For PPV: ocular disease such as limbal stem cell Insufficiency , glaucoma, lagophthalmos
• For penetrating keratoplasty:ocular or systemic disease that would affect epithelial healing, such as severe dry eye, severe lid abnormalities, limbal stem cell deficiency, or corneal anesthesia

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, department of Ophthalmology

Taipei, Taiwan, 10047, Taiwan

Location

Related Publications (1)

• Chen YM, Hu FR, Huang JY, Shen EP, Tsai TY, Chen WL. The effect of topical autologous serum on graft re-epithelialization after penetrating keratoplasty. Am J Ophthalmol. 2010 Sep;150(3):352-359.e2. doi: 10.1016/j.ajo.2010.03.024. Epub 2010 Jun 25.

  PMID: 20579630 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: We-Li Chen , MD
• Organization: Natinal Taiwan University Hospital

chenweili@ntu.edu.tw

886-2-2356

Study Officials

• Wei-Li Chen, MD, PhD

  National Taiwan University Hospital, department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: February 25, 2010
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 14, 2010
• Results First Posted: September 2, 2010

Record last verified: 2010-09

Locations

TW (1)