Pterygium
Conditions
Keywords
Primary Pterygium, Mitomycin C, Amniotic membrane transplantation, Conjunctival autograft, Multi-center randomized clinical trial
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.
Interventions
PROCEDUREMMC
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
PROCEDUREAMT
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
PROCEDURECAG
A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.
PROCEDUREPterygium excision
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of pterygium | One year | Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag |
Secondary
| Measure | Time frame |
|---|---|
| Healing time of conjunctival epithelium | Four weeks |
| Postoperative complications | One year |
| Visual acuity | One year |
| Healing time of corneal epithelium | Four weeks |
Countries
China
Contacts
Primary ContactShiyou Zhou, M.D., Ph.D.
Backup ContactTao Zhou, M.D.
Outcome results
None listed