Clinical trial NCT02102776: Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium
Official title: Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pterygium
Keywords: Primary Pterygium
Mitomycin C
Amniotic membrane transplantation
Conjunctival autograft
Multi-center randomized clinical trial
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 750
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 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of pterygium
timeFrame: One year
Secondary outcomes:
measure: Visual acuity
timeFrame: One year
measure: Healing time of corneal epithelium
timeFrame: Four weeks
measure: Healing time of conjunctival epithelium
timeFrame: Four weeks
measure: Postoperative complications
timeFrame: One year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Xi'an
country: China
facility: Xi'an Eye Hospital
state: Shanxi
city: Ganzi
country: China
facility: Sichuan Ganzi Autonomous Prefecture People's Hospital
state: Sichuan
city: Kunming
country: China
facility: The Fourth Affiliated Hospital, Kunming Medical University
state: Yunnan
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Shiyou Zhou, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: