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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

July 12, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed

6 days until next milestone

Study Start

First participant enrolled

July 20, 2017

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed

Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

July 12, 2017

Last Update Submit

February 21, 2018

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

Restoration of corneal surface
Restoration of a completely epithelized, stable, and avascular corneal surface
1 year

Secondary Outcomes (5)

Recurrence of pterygium
1 year
Reconstruction of palisades of Vogt
1 year
Best corrected visual acuity
1 year
Corneal power and astigmatism
1 year
Corneal haze measurement
1 year

Study Arms (3)

Corneal epithelial autograft

EXPERIMENTAL

pterygium resection combined with femtosecond laser assisted corneal epithelial autograft

Procedure: Corneal epithelial autograftDevice: Femtosecond laser

Limbal conjunctival autograft

ACTIVE COMPARATOR

pterygium resection combined with diamond knife assisted limbal conjunctival autograft

Procedure: Limbal conjunctival autograftDevice: Diamond knife

Simple removal

ACTIVE COMPARATOR

Simple removal of pterygium

Procedure: Simple removal

Interventions

Corneal epithelial autograftPROCEDURE

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.

Corneal epithelial autograft

Limbal conjunctival autograftPROCEDURE

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.

Limbal conjunctival autograft

Simple removalPROCEDURE

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

Simple removal

Diamond knifeDEVICE

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

Limbal conjunctival autograft

Femtosecond laserDEVICE

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

Corneal epithelial autograft

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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);
Prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
Pregnancy (positive test) or lactation;
Participation in another simultaneous medical investigation or clinical trial;
Severe cicatricial eye disease;
Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chunxiao Wanglead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

Yizhi Liu, M.D.Ph.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
PRINCIPAL INVESTIGATOR
Ting Huang, M.D.Ph.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingfeng Zheng, M.D.Ph.D.

CONTACT

+8613922286455 yingfeng.zheng@qq.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Clinical investigator

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 14, 2017

Study Start

July 20, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2019

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Corneal epithelial autograft

Limbal conjunctival autograft

Simple removal

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations