Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium
- Conditions
- Pterygium
- Interventions
- Procedure: AMTProcedure: MMCProcedure: CAGProcedure: Pterygium excision
- Registration Number
- NCT02102776
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 750
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMT after Pterygium Excision Pterygium excision Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. MMC after pterygium excision Pterygium excision Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft. AMT after Pterygium Excision AMT Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. CAG after Pterygium Excision Pterygium excision A conjunctival autograft will be harvested from the superior side of the operating eye's bulbar conjunctiva. Then the graft will be sutured to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. MMC after pterygium excision MMC Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft. CAG after Pterygium Excision CAG A conjunctival autograft will be harvested from the superior side of the operating eye's bulbar conjunctiva. Then the graft will be sutured to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied.
- Primary Outcome Measures
Name Time Method Recurrence of pterygium One year Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
- Secondary Outcome Measures
Name Time Method Visual acuity One year Healing time of corneal epithelium Four weeks Healing time of conjunctival epithelium Four weeks Postoperative complications One year
Trial Locations
- Locations (5)
Sichuan Ganzi Autonomous Prefecture People's Hospital
🇨🇳Ganzi, Sichuan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Xi'an Eye Hospital
🇨🇳Xi'an, Shanxi, China
The Fourth Affiliated Hospital, Kunming Medical University
🇨🇳Kunming, Yunnan, China