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

Not Applicable
Completed
Conditions
Recurrent Pterygium
Interventions
Procedure: MMC
Procedure: LCAG
Procedure: AMG
Registration Number
NCT01319721
Lead Sponsor
Shiyou Zhou
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
96
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group LCAGMMCAfter 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.
Group LCAGAMGAfter 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.
Group AMGLCAGAfter 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.
Group AMGAMGAfter 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.
Primary Outcome Measures
NameTimeMethod
RecurrenceOne 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 Outcome Measures
NameTimeMethod
Healing Time of Corneal Epithelial DefectFour Weeks
ComplicationsOne year
Eye Movement Amplitude (EMA)One Year
Postoperative Conjunctival InflammationOne month

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).

Trial Locations

Locations (1)

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

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