UnknownNot Applicable

Corneal Epithelial Autograft for LSCD

China20 participantsStarted 2017-07-25

Plain-language summary

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

Who can participate

Age range14 Years – 80 Years

SexALL

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Inclusion criteria

✓. Unilateral 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;
✓. 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 pterygium;
✕. 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 diseased eye

Timeframe: 1 year

Restoration of corneal surface in the fellow eye

Timeframe: 1 year

Trial details

NCT IDNCT03217487

SponsorChunxiao Wang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-30

Contact for this trial

Yingfeng Zheng, M.D.Ph.D.

+8613922286455 yingfeng.zheng@qq.com

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency trials