CompletedNot Applicable

Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns

China30 participantsStarted 2018-02-09

Plain-language 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.

Who can participate

Age range4 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

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 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%.

What they're measuring

Success rate of corneal reepithelialization in disease eyes.

Timeframe: 12 months

Trial details

NCT IDNCT03421769

SponsorYingfeng Zheng

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-30

View on ClinicalTrials.gov More Ocular Burns trials