A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Pterygium

Chunxiao Wang1 site in 1 country45 target enrollmentJuly 20, 2017

ConditionsPterygium

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pterygium
Sponsor: Chunxiao Wang
Enrollment: 45
Locations: 1
Primary Endpoint: Restoration of corneal surface
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 20, 2017

End Date

December 30, 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chunxiao Wang

Responsible Party

Sponsor Investigator

Principal Investigator

Chunxiao Wang

Clinical investigator

Sun Yat-sen University

Eligibility Criteria

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;
•Platelet levels \< 150,000 or \> 450,000 per microliter;
•Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female);