Corneal Epithelial Autograft for Pterygium

Pterygium Clinical Trial

Official title:

A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Pterygium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217500
• Other study ID #: 2017KYPJ050
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: February 21, 2018
• Start date: July 20, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2018
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng, M.D.Ph.D.
• Phone: +8613922286455
• Email: yingfeng.zheng[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pterygium

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chunxiao Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of corneal surface	Restoration of a completely epithelized, stable, and avascular corneal surface	1 year
Secondary	Recurrence of pterygium	To observe recurrence of pterygium using slit-lamp microscopy	1 year
Secondary	Reconstruction of palisades of Vogt	To observe the reconstruction of palisades of Vogt using in vivo confocal microscopy.	1 year
Secondary	Best corrected visual acuity	To assess changes of best corrected visual acuity using ETDRS chart	1 year
Secondary	Corneal power and astigmatism	To assess changes of corneal power and astigmatism using autorefractor keratometer	1 year
Secondary	Corneal haze measurement	To observe the scatter of corneal haze using in vivo confocal microscopy	1 year