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

• ClinicalTrials.gov Identifier: NCT01075347
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Results First Posted: September 2, 2010
• Last Update Posted: September 14, 2010
• Sponsor: National Taiwan University Hospital
• Information provided by: National Taiwan University Hospital

Tracking Information

• First Submitted Date: December 4, 2008
• First Posted Date: February 25, 2010
• Results First Submitted Date: July 14, 2010
• Results First Posted Date: September 2, 2010
• Last Update Posted Date: September 14, 2010
• Study Start Date: March 2007
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2010)

Patients With Corneal Epithelial Healing Time Within 14 Days [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: February 24, 2010): Corneal epithelial healing time [ Time Frame: every day till total re-epithelization ]
• Current Secondary Outcome Measures (submitted: August 12, 2010): 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 ]
• Original Secondary Outcome Measures (submitted: February 24, 2010): Incidence of 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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
• Official Title: Clinical Study: Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Corneal Epithelial Defect
• Diabetic Retinopathy
• Penetrating Keratoplasty

Intervention

• Other: autologous serum
  with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
  Other Name: Autoserum
• Other: Non-autologous serum
  without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours

Study Arms

• Active Comparator: Autologous serum use
  Patients treated with additional 20% autoserum after diabetic vitrectomy or penetrating keratoplasty
  Intervention: Other: autologous serum
• Placebo Comparator: Non-autologous serum use
  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
  Intervention: Other: Non-autologous serum

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 12, 2010): 165
• Original Estimated Enrollment (submitted: February 24, 2010): 80
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01075347
• Other Study ID Numbers: 200701021R
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: We-Li Chen , MD, Natinal Taiwan University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: National Taiwan University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wei-Li Chen, MD, PhD; National Taiwan University Hospital, department of Ophthalmology

• PRS Account: National Taiwan University Hospital
• Verification Date: September 2010