UnknownNot Applicable

Corneal Epithelial Autograft for Pterygium

China45 participantsStarted 2017-07-20

Plain-language summary

The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction after excision of pterygium.

Who can participate

Age range18 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

✓. Age between 18 to 80 years old;
✓. Primary pterygium, scheduled for elective surgical excision;
✓. Pterygium encroaching from the nasal side onto the cornea, with less than 180° limbal involvement and without approaching the central visual axis (pupil area);
✓. Morphologically intact palisades of Vogt in a given limbal region;
✓. Absence of any one of the following structures in the limbal region underneath the pterygium: (1) epithelial basal cells with dark cytoplasm and reflective cell borders; (2) at least two prominent palisade ridge structures; (3) at least one circular and/or oval-shaped focal stromal projection;
✓. 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

✕. Limbal stem cell deficiency by ocular surface disorders other than pterygium;
✕. Inability to determine whether the palisades of Vogt underneath the pterygium is absent or not using in vivo confocal microscopy;
✕. 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;

What they're measuring

Restoration of corneal surface

Timeframe: 1 year

Trial details

NCT IDNCT03217500

SponsorChunxiao Wang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-30

Contact for this trial

Yingfeng Zheng, M.D.Ph.D.

+8613922286455 yingfeng.zheng@qq.com

View on ClinicalTrials.gov More Pterygium trials