Limbal Conjunctival Autograft Versus Amniotic Membrane Graft When Combined With Mitomycin C for Recurrent Pterygium: A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Recurrence
Study Overview
Brief Summary
To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal in patients with recurrent pterygium.
Detailed Description
Excision alone for treating recurrent pterygium was reported to be at risk of high recurrence again. As one of adjunctive methods, intraoperative application of a single dose of mitomycin C (MMC) seems to be the most commonly used method for preventing recurrence of pterygium. Additionally, closure of conjunctival defect after excision of pterygium by limbal conjunctival autograft or amniotic membrane have also become popular in recent years. There are a few reports in which MMC combined either limbal conjunctival autograft (LCAG) or amniotic membrane graft (AMG) for the treatment of recurrent pterygium. To assess the effectiveness and safety of these two combined approaches, the investigator plans to work on a randomized comparative and prospective trial of recurrent pterygium extensive excision with intraoperative 0.02% MMC application comparing LCAG to AMG.The patients enrolled in this study will be followed for at least 12 months after the surgery. Recurrence was defined as fibrovascular tissue crossing the limbus on to the clear cornea in the area of previous pterygium excision.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patients had one or two eye(s) with unilateral recurrent pterygium.
- •Recurrent pterygium：be defined as of fibrovascular tissue onto the cornea for any distance in the position of a previous pterygium.
- •Willingness to participate in research project and to attend research time.
Exclusion Criteria
- •Poor general health.
- •Pregnant or lactating women.
- •Patients with collagen vascular diseases or other autoimmune diseases.
- •Patients with any evidence of stem cell deficiency.
- •Patients with glaucoma who might require future filtering surgery.
- •Patients with ocular infection.
- •Patients with an allergy to mitomycin C, tobramycin or dexamethasone.
Outcomes
Primary Outcomes
Recurrence
Time Frame: One Year
Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea.
Secondary Outcomes
- Healing Time of Corneal Epithelial Defect(Four Weeks)
- Eye Movement Amplitude (EMA)(One Year)
- Postoperative Conjunctival Inflammation(One month)
- Complications(One year)
Investigators
Shiyou Zhou
M.D., Ph.D.
Sun Yat-sen University