Corneal Epithelial Autograft for Pterygium

Not Applicable

• Conditions: Pterygium
• Interventions: Procedure: Simple removal; Procedure: Limbal conjunctival autograft; Procedure: Corneal epithelial autograft; Device: Femtosecond laser; Device: Diamond knife

• Registration Number: NCT03217500
• Lead Sponsor: Chunxiao Wang

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

Not available

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-07-20
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simple removal	Simple removal	Simple removal of pterygium
Limbal conjunctival autograft	Limbal conjunctival autograft	pterygium resection combined with diamond knife assisted limbal conjunctival autograft
Corneal epithelial autograft	Corneal epithelial autograft	pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
Corneal epithelial autograft	Femtosecond laser	pterygium resection combined with femtosecond laser assisted corneal epithelial autograft
Limbal conjunctival autograft	Diamond knife	pterygium resection combined with diamond knife assisted limbal conjunctival autograft

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Reconstruction of palisades of Vogt	1 year	To observe the reconstruction of palisades of Vogt using in vivo confocal microscopy.
Corneal haze measurement	1 year	To observe the scatter of corneal haze using in vivo confocal microscopy
Recurrence of pterygium	1 year	To observe recurrence of pterygium using slit-lamp microscopy
Best corrected visual acuity	1 year	To assess changes of best corrected visual acuity using ETDRS chart
Corneal power and astigmatism	1 year	To assess changes of corneal power and astigmatism using autorefractor keratometer

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity; 🇨🇳 Guangzhou, Guangdong, China