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

December 14, 2009 updated by: National Taiwan University Hospital

Phase 1 Study of Topical Autologous Insulin Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

Topical insulin application has been proved recently to increase corneal reepithelization rate over diabetic animals. However, its effectiveness on corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy and penetrating keratoplasty has not been reported. In this study, we plan to perform a prospective randomized study to determine the effectiveness of topical insulin 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 randomized 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 insulin eye drops in addition to conventional postoperative eye drops. The duration for the corneal 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: To evaluate the treatment effects of topical insulin eye drops for promoting corneal epithelium wound healing in patients receiving pars planar 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 view1 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. Topical insulin application has been known to increase corneal reepithelization rate over diabetic animals, has is known to have no influence on systemic glucose level in humans and animals. In this study, we plan to perform a prospective randomized study to determine the effectiveness of topical insulin eye drops as a primary treatment in corneal epithelial defect following vitrectomy in diabetic patients and penetrating keratoplasty.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10047
        • National Taiwan University Hospital, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic patients with proliferative retinopathy receiving PPV
  • Patients qualified for penetrating keratoplasty
  • DM control blood sugar AC < 200mg/dl
  • no limbus defect
  • no glaucoma before and after surgery
  • Patients willing to receive surgery, blood drawl and OPD follow up
  • no previous corneal epithelial defect or disease

Exclusion Criteria:

  • Limbus defect
  • postsurgical use of other eye drops
  • incomplete eyelid closure
  • glaucoma
  • unable to be followed up postoperatively
  • poor visual acuity or poor prognostic visual acuity
  • corneoneuropathy
  • severe dry eye syndrome
  • pregnant
  • receive eye surgery within one month after the previous eye surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy receiving topical insulin eye drops in addition to conventional postoperative eye drops
Drug: Topical insulin eye drops
Regular insulin injection diluted to 100U/ml After the day of surgery, besides topical steroid, antibiotic and mydriatics, the patient receives topical insulin eye drops every two hours, except from 10pm to 8am, until the epithelial defect is totally closed
Active Comparator: 2
Corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for penetrating keratoplasty receiving topical insulin eye drops in addition to conventional postoperative eye drops
Drug: Topical insulin eye drops
Regular insulin injection diluted to 100U/ml After the day of surgery, besides topical steroid, antibiotic and mydriatics, the patient receives topical insulin eye drops every two hours, except from 10pm to 8am, until the epithelial defect is totally closed
Placebo Comparator: 3
Corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy treated with conventional postoperative eye drops
Drug: Conventional postoperative eye drops
topical steroid, antibiotic and mydriatics
Placebo Comparator: 4
corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for penetrating keratoplasty receiving conventional postoperative eye drops
Drug: Conventional postoperative eye drops
topical steroid, antibiotic and mydriatics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration for the corneal surface to completely re-epithelize
Time Frame: 1week, 2 weeks, 1 month, 2 month, 3 month, 6 month
1week, 2 weeks, 1 month, 2 month, 3 month, 6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization)
Time Frame: 1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month
1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month
Incidence of recurrent epithelial break down after initial epithelization
Time Frame: 1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month
1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 14, 2009

First Submitted That Met QC Criteria

December 14, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 14, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200803017M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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