Pterygium Clinical Trial
Official title:
Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 750 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Primary pterygium - Willingness to participate in research project and to attend research follow-up - Adults (age 18 to 80 years old) - Patients must not meet any of the following exclusion criteria Exclusion Criteria: - Pregnant,breast-feeding women or patients with poor general health - Patients with significant ocular or lid pathology, such as Sjogren's Syndrome, infection, exposure keratitis, glaucoma, active uveitis, retinal detachment and trauma - Patients with previous surgery on ocular surface, such as trabeculectomy, strabismus surgery - Patients with allergy to intraoperative or postoperative drugs, such as mitomycin C, tobramycin or local anesthetics |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Sichuan Ganzi Autonomous Prefecture People's Hospital | Ganzi | Sichuan |
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
China | The Fourth Affiliated Hospital, Kunming Medical University | Kunming | Yunnan |
China | Xi'an Eye Hospital | Xi'an | Shanxi |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of pterygium | Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag | One year | No |
Secondary | Visual acuity | One year | No | |
Secondary | Healing time of corneal epithelium | Four weeks | No | |
Secondary | Healing time of conjunctival epithelium | Four weeks | No | |
Secondary | Postoperative complications | One year | No |
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