Corneal Epithelial Defect, Diabetic Retinopathy, Penetrating Keratoplasty
Conditions
Keywords
autoserum, ocular surgery, corneal epithelium healing
Brief summary
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
Detailed description
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.
Interventions
OTHERautologous serum
with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
OTHERNon-autologous serum
without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* patients with proliferative diabetic retinopathy who's condition need to receive pars plana vitrectomy or patients who need to receive penetrating keratoplasty
Exclusion criteria
* For PPV: ocular disease such as limbal stem cell Insufficiency , glaucoma, lagophthalmos * For penetrating keratoplasty:ocular or systemic disease that would affect epithelial healing, such as severe dry eye, severe lid abnormalities, limbal stem cell deficiency, or corneal anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Corneal Epithelial Healing Time Within 14 Days | every day till total re-epithelization up to 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. |
Secondary
| Measure | 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 |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Autologous Serum Use Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty | 82 |
| Non-autologous Serum Use Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty | 83 |
| Total | 165 |
Baseline characteristics
| Characteristic | Non-autologous Serum Use | Autologous Serum Use | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 40 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 42 Participants | 87 Participants |
| Age Continuous | 59.8 years STANDARD_DEVIATION 17.6 | 60.8 years STANDARD_DEVIATION 18.1 | 60.3 years STANDARD_DEVIATION 19.3 |
| Region of Enrollment Taiwan | 83 participants | 82 participants | 165 participants |
| Sex: Female, Male Female | 42 Participants | 44 Participants | 86 Participants |
| Sex: Female, Male Male | 41 Participants | 38 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 82 | 0 / 83 |
| serious Total, serious adverse events | 0 / 82 | 0 / 83 |
Outcome results
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.
Time frame: every day till total re-epithelization up to 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Serum Use | Patients With Corneal Epithelial Healing Time Within 14 Days | 78 participants |
| Non-autologous Serum Use | Patients With Corneal Epithelial Healing Time Within 14 Days | 73 participants |
Secondary
Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)
Time frame: every day till total re-epithelization up to 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Autologous Serum Use | Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization) | 0 participants |
| Non-autologous Serum Use | Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization) | 0 participants |