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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01031888
First received: December 14, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Corneal Epithelial Defects After Ocular Surgeries
Drug: Topical insulin eye drops
Drug: Conventional postoperative eye drops
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Topical Autologous Insulin Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Duration for the corneal surface to completely re-epithelize [ Time Frame: 1week, 2 weeks, 1 month, 2 month, 3 month, 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of recurrent epithelial break down after initial epithelization [ Time Frame: 1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031888

Locations
Taiwan
National Taiwan University Hospital, department of Ophthalmology
Taipei, Taiwan, 10047
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wei-Li Chen, MD, PhD National Taiwan University Hospital, department of Ophthalmology
  More Information

No publications provided

Responsible Party: Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01031888     History of Changes
Other Study ID Numbers: 200803017M
Study First Received: December 14, 2009
Last Updated: December 14, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Corneal re-epithelialization
Topical insulin application
pars planar vitrectomy
diabetic retinopathy
penetrating keratoplasty

Additional relevant MeSH terms:
Tetrahydrozoline
Insulin
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 14, 2014