NCT03421769

Brief Summary

The purpose of this pilot study is to explore whether corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal autograft (LA) with AMLK for ocular surface reconstruction in patients with severe ocular burns.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

January 20, 2018

Last Update Submit

February 27, 2020

Conditions

Ocular Burns

Outcome Measures

Primary Outcomes (1)

  • Success rate of corneal reepithelialization in disease eyes.

    The percentage of patients with completely epithelized and avascular corneal surface in disease eyes.

    12 months

Study Arms (2)

EA and AMLK

EXPERIMENTAL

Corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe ocular burns.

Procedure: EA and AMLK

LA and AMLK

ACTIVE COMPARATOR

Limbal autograft (LA) combined with AMLK is used for the treatment of patients with severe ocular burns.

Procedure: LA and AMLK

Interventions

EA and AMLKPROCEDURE

A 7-9mm diameter corneal epithelial tissue will be obtained from the fellow eye using femtosecond laser technology. This epithelial autograft (EA) is then ready for transplantation on the disease eye, following the procedure of allogeneic middle lamellar keratoplasty (AMLK).

EA and AMLK
LA and AMLKPROCEDURE

A 3-clock-hour limbal autograft (LA) will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following the procedure of AMLK.

LA and AMLK

Eligibility Criteria

Age4 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral severe ocular burns with more than half limbal stem cells deficiency (LSCD). The history of the disease is at least 12 months at the time of screening visit.
  • Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea.
  • Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study.

You may not qualify if:

  • LSCD of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement.
  • LSCD by ocular surface disorders other than ocular burns.
  • Eyelids malposition.
  • The center corneal thickness\<450µm, the depth of corneal opacity\<150µm or the full corneal lamellar opacity.
  • High myopia with a spherical equivalent of -15.0 D or less.
  • Corneal or ocular surface infection within 30 days prior to study entry.
  • Ocular surface malignancy.
  • Uncontrolled diabetes with most recent HgA1c greater than 8.5%.
  • Renal failure with creatinine clearance ≤ 25mL/min per 1.73 m2.
  • Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L.
  • Platelet levels \< 150,000 or \> 450,000 per microliter.
  • Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female);
  • Prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy.
  • Pregnancy (positive test) or lactation.
  • Participation in another simultaneous medical investigation or clinical trial.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2018

First Posted

February 5, 2018

Study Start

February 9, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

CN(1)