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

NCT01031888 | Completed Phase 1

• 1 other identifier: 200803017M
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corneal Epithelial Defects After Ocular Surgeries

Keywords

Corneal re-epithelialization; Topical insulin application; pars planar vitrectomy; diabetic retinopathy; penetrating keratoplasty

Outcome Measures

Primary Outcomes (1)

• Duration for the corneal surface to completely re-epithelize

  1week, 2 weeks, 1 month, 2 month, 3 month, 6 month

Secondary Outcomes (2)

• Incidence of corneal complications due to delayed surface re-epithelization (e.g. infectious corneal ulcer, corneal melting, sterile corneal ulcer, corneal neovascularization)

  1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month

• Incidence of recurrent epithelial break down after initial epithelization

  1 week, 2 weeks, 1 month, 2 month, 3 month, 6 month

Study Arms (4)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

3

PLACEBO COMPARATOR

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

4

PLACEBO COMPARATOR

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

Interventions

Topical insulin eye drops DRUG

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

1; 2

Conventional postoperative eye drops DRUG

topical steroid, antibiotic and mydriatics

3; 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, department of Ophthalmology

Taipei, 10047, Taiwan

Location

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

Study Officials

• Wei-Li Chen, MD, PhD

  National Taiwan University Hospital, department of Ophthalmology

  PRINCIPAL INVESTIGATOR

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 14, 2009
• First Posted: December 15, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 15, 2009

Record last verified: 2009-12

Locations

TW (1)