Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane

Shiyou Zhou

Status: Completed

Conditions: Recurrent Pterygium

Treatments: Procedure: LCAG; Procedure: MMC; Procedure: AMG

Study type: Interventional

Funder types: Other

Identifiers

NCT01319721

20101215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 2 patient groups

Group LCAG

Active Comparator group

Description:

After extensive excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.

Treatment:

Procedure: AMG

Procedure: MMC

Group AMG

Active Comparator group

Description:

After excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.

Treatment:

Procedure: AMG

Procedure: LCAG