CompletedNot Applicable

Corneal Epithelial Allograft From Living-related Donor for LSCD

China20 participantsStarted 2017-07-27

Plain-language 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).

Who can participate

Age range14 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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%;

What they're measuring

Restoration of corneal surface in the recipient

Timeframe: 1 year

Restoration of corneal surface in the donor

Timeframe: 1 year

Trial details

NCT IDNCT03217435

SponsorChunxiao Wang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-13

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency trials