Recurrent Pterygium
Conditions
Keywords
recurrent pterygium, pterygium, limbal conjunctival autograft, conjunctival autograft, mitomycin c
Brief summary
The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence
Detailed description
Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect. Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.
Interventions
PROCEDUREPterygium excision
Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
PROCEDUREIntraoperative mitomycin C
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
PROCEDUREConjunctival autograft
A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
PROCEDURELimbal conjunctival autograft
A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
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
* Recurrent pterygium * Willingness to participate in research project and to attend research time * At least 6 months after last pterygium surgery
Exclusion criteria
* Pregnant,breast-feeding women or poor general health * Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma * Patients with allergy to mitomycin C,tobramycin or local anesthetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of pterygium | One year |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity | One year |
| Healing time of corneal epithelium | Four weeks |
| Healing time of conjunctival epithelium | Four weeks |
| Postoperative complications | One year |
Countries
China
Contacts
Primary ContactZhou Shiyou, M.D., Ph.D.
Backup ContactZhou Tao, M.D.
Outcome results
None listed