Clinical trial NCT03217500: Corneal Epithelial Autograft for Pterygium
Official title: A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Pterygium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pterygium
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Restoration of corneal surface
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence of pterygium
timeFrame: 1 year
measure: Reconstruction of palisades of Vogt
timeFrame: 1 year
measure: Best corrected visual acuity
timeFrame: 1 year
measure: Corneal power and astigmatism
timeFrame: 1 year
measure: Corneal haze measurement
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Ting Huang, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: