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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.
Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Recurrence
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.
Time frame: One Year
Complications
Time frame: One year
Healing Time of Corneal Epithelial Defect
Time frame: Four Weeks
Eye Movement Amplitude (EMA)
Time frame: One Year
Postoperative Conjunctival Inflammation
The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe).
Time frame: One month
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