Trial Outcomes & Findings for Topical Autologous Serum Application for the Treatment of Corneal Epithelium Defect After Ocular Surgeries (NCT NCT01075347)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

165 participants

Primary outcome timeframe

every day till total re-epithelization up to 14 days

Results posted on

2010-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Autologous Serum Use Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Non-autologous Serum Use Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Overall Study STARTED	82	83
Overall Study COMPLETED	82	83
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Serum Use n=82 Participants Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Non-autologous Serum Use n=83 Participants Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty	Total n=165 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=93 Participants	45 Participants n=4 Participants	87 Participants n=27 Participants
Age, Categorical >=65 years	40 Participants n=93 Participants	38 Participants n=4 Participants	78 Participants n=27 Participants
Age Continuous	60.8 years STANDARD_DEVIATION 18.1 • n=93 Participants	59.8 years STANDARD_DEVIATION 17.6 • n=4 Participants	60.3 years STANDARD_DEVIATION 19.3 • n=27 Participants
Sex: Female, Male Female	44 Participants n=93 Participants	42 Participants n=4 Participants	86 Participants n=27 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	41 Participants n=4 Participants	79 Participants n=27 Participants
Region of Enrollment Taiwan	82 participants n=93 Participants	83 participants n=4 Participants	165 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Autologous Serum Use n=82 Participants Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Non-autologous Serum Use n=83 Participants Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Patients With Corneal Epithelial Healing Time Within 14 Days	78 participants	73 participants

SECONDARY outcome

Timeframe: every day till total re-epithelization up to 14 days

Outcome measures

Outcome measures
Measure	Autologous Serum Use n=82 Participants Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty	Non-autologous Serum Use n=83 Participants Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)	0 participants	0 participants

Adverse Events

Autologous Serum Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-autologous Serum Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

We-Li Chen , MD

Natinal Taiwan University Hospital

Phone: 886-2-2356

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place