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

NCT ID: NCT01075347

Last Updated: 2010-09-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-31

Brief Summary

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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

Detailed Description

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Purpose: To evaluate the treatment effect of autologous serum eye drops for promoting corneal epithelium wound healing in patients receiving pars plana vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty. Background: During PPV for diabetic retinopathy retinopathy and penetrating keratoplasty, removal of the edematous corneal epithelial layer was usually required in order to obtain a better surgical view or enhance the postoperative epithelial wound healing process. However, delayed epithelial healing was frequently found in these patients after surgeries. In addition, corneal epithelial defect is also frequent found in diabetic patients after PPV even corneal epithelial debridement is not performed during the operation. Autologous serum, the fluid component of full blood after blood clotting, contains a large variety of growth factors, vitamins, and immunoglobulins. These epitheliotropic factors are thought to be responsible for the therapeutic effect of serum observed on ocular surface disorders. The effects of serum to promote epithelial wound healing have been well documented in cell culture system in a variety of epithelial cell types including corneal epithelial cells. Autologous serum eye drops have also been demonstrated to be beneficial in the treatment of persistent corneal epithelial defects. In this study, we planned a prospective study to determine the effectiveness of autologous serum tears as a primary treatment in corneal epithelial defect following vitrectomy in diabetic patients and penetrating keratoplasty.

Conditions

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Corneal Epithelial Defect Diabetic Retinopathy Penetrating Keratoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Autologous serum use

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

Group Type ACTIVE_COMPARATOR

autologous serum

Intervention Type OTHER

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

Non-autologous serum use

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

Group Type PLACEBO_COMPARATOR

Non-autologous serum

Intervention Type OTHER

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

Interventions

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autologous serum

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

Intervention Type OTHER

Non-autologous serum

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

Intervention Type OTHER

Other Intervention Names

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Autoserum

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Natinal Taiwan University Hospital

Principal Investigators

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Wei-Li Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, department of Ophthalmology

Locations

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National Taiwan University Hospital, department of Ophthalmology

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 20579630 (View on PubMed)

Other Identifiers

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200701021R

Identifier Type: -

Identifier Source: org_study_id