Corneal Epithelial Autograft for Pterygium

ID: NCT03217500
Status: Recruiting
Phase: N/A
Start Date: July 20, 2017
First Submitted: July 12, 2017
Last Updated: February 21, 2018
Results: N/A
Sponsors & Collaborators: Chunxiao Wang
Location: China
Conditions: Pterygium
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Pterygium

Procedure: Corneal epithelial autograft
Other Names
Procedure: Limbal conjunctival autograft
Other Names
Procedure: Simple removal
Other Names
Device: Diamond knife
Other Names
Device: Femtosecond laser
Other Names
N/A

Tracking Information

First Submitted DateJuly 12, 2017
Last Update Posted DateFebruary 21, 2018
Actual Start DateJuly 20, 2017
Anticipated Completion DateDecember 30, 2019
Actual Primary Completion DateDecember 30, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Restoration of corneal surface [Time Frame: 1 year]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Recurrence of pterygium [Time Frame: 1 year]

    To observe recurrence of pterygium using slit-lamp microscopy

  • Reconstruction of palisades of Vogt [Time Frame: 1 year]

    To observe the reconstruction of palisades of Vogt using in vivo confocal microscopy.

  • Best corrected visual acuity [Time Frame: 1 year]

    To assess changes of best corrected visual acuity using ETDRS chart

  • Corneal power and astigmatism [Time Frame: 1 year]

    To assess changes of corneal power and astigmatism using autorefractor keratometer

  • Corneal haze measurement [Time Frame: 1 year]

    To observe the scatter of corneal haze using in vivo confocal microscopy

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleCorneal Epithelial Autograft for Pterygium
Official TitleA Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Pterygium
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
45
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Pterygium
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
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.

Other Names
Procedure: Simple removal

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

Other Names
Device: Diamond knife

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

Other Names
Device: Femtosecond laser

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

Other Names
Study Groups/Cohorts
Corneal epithelial autograft
pterygium resection combined with femtosecond laser assisted corneal epithelial autograft

Limbal conjunctival autograft
pterygium resection combined with diamond knife assisted limbal conjunctival autograft

Simple removal
Simple removal of pterygium

Study Arms
Experimental Corneal epithelial autograft
pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
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.

Experimental Corneal epithelial autograft
pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
Device : Femtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation

Active Comparator Limbal conjunctival autograft
pterygium resection combined with diamond knife assisted limbal conjunctival autograft
Device : Diamond knife
A diamond knife to create a particular shaped limbal graft for transplantation

Active Comparator Limbal conjunctival autograft
pterygium resection combined with diamond knife assisted limbal conjunctival autograft
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.

Active Comparator Simple removal
Simple removal of pterygium
Procedure : Simple removal
Simple removal of the recipient's pterygium tissue, with the Tenon capsule exposed.

Arm Intervention/Treatment
Experimental Corneal epithelial autograft
pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
Procedure : Corneal epithelial autograft
Experimental Corneal epithelial autograft
pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
Device : Femtosecond laser
Active Comparator Limbal conjunctival autograft
pterygium resection combined with diamond knife assisted limbal conjunctival autograft
Device : Diamond knife
Active Comparator Limbal conjunctival autograft
pterygium resection combined with diamond knife assisted limbal conjunctival autograft
Procedure : Limbal conjunctival autograft
Active Comparator Simple removal
Simple removal of pterygium
Procedure : Simple removal

Recruitment Information

Recruitment Status:Recruiting
Enrollment45
Completion DateDecember 30, 2019
Eligibility Criteria: Inclusion Criteria:
1. Age between 18 to 80 years old;
2. Primary pterygium, scheduled for elective surgical excision;
3. Pterygium encroaching from the nasal side onto the cornea, with less than 180° limbal involvement and without approaching the central visual axis (pupil area);
4. Morphologically intact palisades of Vogt in a given limbal region;
5. 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;
6. 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:
1. Limbal stem cell deficiency by ocular surface disorders other than pterygium;
2. Inability to determine whether the palisades of Vogt underneath the pterygium is absent or not using in vivo confocal microscopy;
3. High myopia with a spherical equivalent of -15.0 D or less;
4. Corneal or ocular surface infection within 30 days prior to study entry;
5. Ocular surface malignancy;
6. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
7. Renal failure with creatinine clearance< 25ml/min;
8. Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
9. Platelet levels < 150,000 or > 450,000 per microliter;
10. Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
11. 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;
12. Pregnancy (positive test) or lactation;
13. Participation in another simultaneous medical investigation or clinical trial;
14. Severe cicatricial eye disease;
15. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
16. Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
17. Any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
18. Signs of current infection, including fever and treatment with antibiotics;
19. Active immunological diseases;
20. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
GenderAll
Age18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
China

Administrative Information

NCT Number:NCT03217500
Other Study ID Numbers
2017KYPJ050
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyChunxiao Wang, Sun Yat-sen University
Study Sponsor
Chunxiao Wang
Collaborators
Not Available
Investigators
Principal Investigator
Ting Huang, M.D.Ph.D.
Zhongshan Ophthalmic Center, Sun Yet-sen University
Principal Investigator
Yizhi Liu, M.D.Ph.D.
Zhongshan Ophthalmic Center, Sun Yet-sen University