The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.
Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
750
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGXi'an Eye Hospital
Xi’an, Shanxi, China
Recurrence of pterygium
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
Time frame: One year
Visual acuity
Time frame: One year
Healing time of corneal epithelium
Time frame: Four weeks
Healing time of conjunctival epithelium
Time frame: Four weeks
Postoperative complications
Time frame: One year
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Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
Sichuan Ganzi Autonomous Prefecture People's Hospital
Ganzi, Sichuan, China
RECRUITINGThe Fourth Affiliated Hospital, Kunming Medical University
Kunming, Yunnan, China
RECRUITING