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Corneal Epithelial Autograft for Pterygium

NCT03217500 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-02-22

No results posted yet for this study

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.

Conditions

  • Pterygium

Interventions

PROCEDURE

Corneal epithelial autograft

After removal of the recipient's pterygium tissue, a donor epithelial tissue equal in length to the bared limbus, will be obtained from the peripheral epithelial of the same eye (corneal epithelial autograft) using femtosecond laser technology. The epithelial graft will be sutured to the recipient limbal bed, with the goal of reconstruction of palisades of Vogt. The graft will act as a barrier to regrowth of pterygium. The area of the graft will be left with the Tenon capsule exposed.

PROCEDURE

Limbal conjunctival autograft

After removal of the recipient's pterygium tissue, an adjustable diamond knife will be used to create a superficial circumferential incision at the corneal end of the limbal vascular arcade, equal in length to the bared limbus. This will be followed by harvesting the limbal-conjunctival flap. The limbal-conjunctival autograft will be sutured to the recipient bed, with the Tenon capsule exposed. The graft will serve as a barrier to regrowth of pterygium.

PROCEDURE

Simple removal

Simple removal of the recipient's pterygium tissue, with the Tenon capsule exposed.

DEVICE

Diamond knife

A diamond knife to create a particular shaped limbal graft for transplantation

DEVICE

Femtosecond laser

A commercial femtosecond laser to create a particular shaped graft for transplantation

Sponsors & Collaborators

  • Chunxiao Wang

    lead OTHER

Principal Investigators

  • Yizhi Liu, M.D.Ph.D. · Zhongshan Ophthalmic Center, Sun Yat-sen University

  • Ting Huang, M.D.Ph.D. · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2018-12-30
Completion
2019-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217500 on ClinicalTrials.gov