Topical Autologous Insulin Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
NCT ID: NCT01031888
Last Updated: 2009-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
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
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
3
Corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for diabetic retinopathy treated with conventional postoperative eye drops
Conventional postoperative eye drops
topical steroid, antibiotic and mydriatics
4
corneal epithelial wound healing in patients who received pars planar vitrectomy (PPV) for penetrating keratoplasty receiving conventional postoperative eye drops
Conventional postoperative eye drops
topical steroid, antibiotic and mydriatics
Interventions
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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
Conventional postoperative eye drops
topical steroid, antibiotic and mydriatics
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University, Department of Ophthalmology
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
Countries
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Other Identifiers
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200803017M
Identifier Type: -
Identifier Source: org_study_id