Clinical trial NCT01319721: Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane
Official title: Limbal Conjunctival Autograft Versus Amniotic Membrane Graft When Combined With Mitomycin C for Recurrent Pterygium: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Pterygium
Keywords: Amniotic membrane
Limbal conjunctival autograft
Limbal
Conjunctival
Mitomycin C
Recurrent pterygium
Pterygium
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence
timeFrame: One Year
Secondary outcomes:
measure: Complications
timeFrame: One year
measure: Healing Time of Corneal Epithelial Defect
timeFrame: Four Weeks
measure: Eye Movement Amplitude (EMA)
timeFrame: One Year
measure: Postoperative Conjunctival Inflammation
timeFrame: One month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Shiyou Zhou, MD, PHD
role: STUDY_DIRECTOR
References: