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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous serum use | Active Comparator | Patients treated with additional 20% autoserum after diabetic vitrectomy or penetrating keratoplasty |
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| Non-autologous serum use | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous serum | Other | with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Patients With Corneal Epithelial Healing Time Within 14 Days | Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for >14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients. | every day till total re-epithelization up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization) | every day till total re-epithelization up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei-Li Chen, MD, PhD | National Taiwan University Hospital, department of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, department of Ophthalmology | Taipei | Taiwan | 10047 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20579630 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Serum Use | Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty |
| FG001 | Non-autologous Serum Use | Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Non-autologous serum | Other | without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Serum Use | Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty |
| BG001 | Non-autologous Serum Use | Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Corneal Epithelial Healing Time Within 14 Days | Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for >14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients. | Posted | Number | participants | every day till total re-epithelization up to 14 days |
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| Secondary | Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization) | Posted | Number | participants | every day till total re-epithelization up to 14 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous Serum Use | Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty | 0 | 82 | 0 | 82 | ||
| EG001 | Non-autologous Serum Use | Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty | 0 | 83 | 0 | 83 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| We-Li Chen , MD | Natinal Taiwan University Hospital | 886-2-2356 | 5206 | chenweili@ntu.edu.tw |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| >=65 years |
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| Male |
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