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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01075347
• Collaborator: (none)
• Enrollment: 165
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Epithelial Defect; Diabetic Retinopathy; Penetrating Keratoplasty	Other: autologous serum; Other: Non-autologous serum	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Study: Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Autologous serum use Patients treated with additional 20% autoserum after diabetic vitrectomy or penetrating keratoplasty	Other: autologous serum; with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours; Other Names: Autoserum
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	Other: Non-autologous serum; without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital, department of Ophthalmology	Taipei		Taiwan	10047

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01075347
• Other Study ID Numbers: 200701021R
• First Posted: Feb 25, 2010
• Last Update Posted: Sep 14, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: autoserum; ocular surgery; corneal epithelium healing
• Additional relevant MeSH terms: Diabetic Retinopathy

Study Results

Participant Flow

Arm/Group Title	Autologous Serum Use	Non-autologous Serum Use
Arm/Group Description	Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Period Title: Overall Study
STARTED	82	83
COMPLETED	82	83
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Autologous Serum Use	Non-autologous Serum Use	Total
Arm/Group Description	Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty	Total of all reporting groups
Overall Participants	82	83	165
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	42 51.2%	45 54.2%	87 52.7%
>=65 years	40 48.8%	38 45.8%	78 47.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.8 (18.1)	59.8 (17.6)	60.3 (19.3)
Sex: Female, Male (Count of Participants)
Female	44 53.7%	42 50.6%	86 52.1%
Male	38 46.3%	41 49.4%	79 47.9%
Region of Enrollment (participants) [Number]
Taiwan	82 100%	83 100%	165 100%

Outcome Measures

1. Primary Outcome

Title	Patients With Corneal Epithelial Healing Time Within 14 Days
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Serum Use	Non-autologous Serum Use
Arm/Group Description	Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Measure Participants	82	83
Number [participants]	78 95.1%	73 88%

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Serum Use	Non-autologous Serum Use
Arm/Group Description	Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Measure Participants	82	83
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Autologous Serum Use		Non-autologous Serum Use
Arm/Group Description	Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty		Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
All Cause Mortality
	Autologous Serum Use		Non-autologous Serum Use
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Autologous Serum Use		Non-autologous Serum Use
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/83 (0%)
Other (Not Including Serious) Adverse Events
	Autologous Serum Use		Non-autologous Serum Use
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/83 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.