NCT03498846

Brief Summary

The purpose of this pilot study is to explore whether modified 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 corneal burn.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2020

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

April 7, 2018

Last Update Submit

September 5, 2019

Conditions

Corneal Burn

Outcome Measures

Primary Outcomes (1)

  • Success rate of corneal reepithelialization in disease eyes

    The success rate of patients with completely epithelized and avascular corneal surface in disease eyes

    12 months

Study Arms (2)

Modified EA and AMLK

EXPERIMENTAL

Modified corneal epithelial autograft (EA) combined with allogeneic middle lamellar keratoplasty (AMLK) is used for the treatment of patients with severe corneal burn.

Procedure: Modified EA and AMLK

LA and AMLK

ACTIVE COMPARATOR

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

Procedure: LA and AMLK

Interventions

Modified EA and AMLKPROCEDURE

Two pieces of corneal epithelial tissue with 2mmx3mm 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).

Modified 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 corneal burn 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.
  • +5 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

RECRUITING

MeSH Terms

Conditions

Eye Burns

Condition Hierarchy (Ancestors)

Eye InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesBurnsWounds and Injuries

Central Study Contacts

Yingfeng Zheng

CONTACT

+8613922286455zhyfeng@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

April 7, 2018

First Posted

April 17, 2018

Study Start

May 10, 2018

Primary Completion

December 9, 2019

Study Completion

May 9, 2020

Last Updated

September 9, 2019

Record last verified: 2019-09

Locations

CN(1)