Corneal Epithelial Allograft From Living-related Donor for LSCD

NCT03217435 | Completed

• 1 other identifier: 2017KYPJ057
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial allograft from living-related donor is more effective than limbal conjunctival allograft from living-related donor for ocular surface reconstruction in patients with limbal stem cell deficiency (LSCD).

Conditions

Limbal Stem Cell Deficiency

Outcome Measures

Primary Outcomes (2)

• Restoration of corneal surface in the recipient

  Restoration of a completely epithelized, stable, and avascular corneal surface in the recipient

  1 year

• Restoration of corneal surface in the donor

  Restoration of a completely epithelized, stable, and avascular corneal surface in the donor

  1 year

Secondary Outcomes (8)

• Uncorrected and best-corrected visual acuity of recipients and donors

  1 year

• Corneal power, astigmatism and aberration of recipients and donors

  1 year

• Corneal sensation of recipients and donors

  1 year

• Corneal thickness of recipients and donors

  1 year

• Density of stromal nerve and stromal keratocytes of recipients and donors

  1 year

Study Arms (2)

Cornea epithelial allograft

EXPERIMENTAL

Femtosecond laser assisted corneal epithelial allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)

Procedure: Corneal epithelial allograft; Device: Femtosecond laser

Limbal conjunctival allograft

ACTIVE COMPARATOR

Diamond knife assisted limbus conjunctival allograft from live relatives in the treatment of limbal stem cell deficiency (LSCD)

Procedure: Limbal conjunctival allograft; Device: Diamond knife

Interventions

Corneal epithelial allograft PROCEDURE

A living-related donor's epithelial flap, equal in area to the recipient's diseased cornea bed, will be created using femtosecond laser technology. This corneal epithelial allograft is then ready for transplantation on the recipient's disease eye, following removal of the recipient's scarred and diseased epithelium.

Cornea epithelial allograft

Limbal conjunctival allograft PROCEDURE

A 3- to 5- clock hour limbal-conjunctival allograft will be obtained from the living-related eye. This is then ready for transplantation on the recipient's disease eye following removal of the recipient's scarred and diseased epithelium.

Limbal conjunctival allograft

Femtosecond laser DEVICE

A commercial femtosecond laser to create a particular shaped graft for transplantation

Cornea epithelial allograft

Diamond knife DEVICE

A diamond knife to create a particular shaped limbal graft for transplantation

Limbal conjunctival allograft

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• LSCD secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit;
• Presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea;
• Having a human leukocyte antigen (HLA)-matched living-related donor (≥4/6 HLA-A/B/DR matched);
• Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.

You may not qualify if:

• Recipients:
• 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 burn;
• Eyelids malposition;
• The center corneal thickness\<450µm, the depth of corneal opacity \> 150µm;
• 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 Hemoglobin A1c greater than 8.5%;
• Renal failure with creatinine clearance\< 25ml/min;
• 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;

Sponsors & Collaborators

• Chunxiao Wang: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Yizhi Liu, M.D.Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Ting Huang, M.D.Ph.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: Clinical investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: July 27, 2017
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

CN (1)