Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C

Sun Yat-sen University

Status: Unknown

Conditions: Recurrent Pterygium

Treatments: Procedure: Intraoperative mitomycin C; Procedure: Pterygium excision; Procedure: Conjunctival autograft; Procedure: Limbal conjunctival autograft

Study type: Interventional

Funder types: Other

Identifiers

NCT04463901

20150527

Details and patient eligibility

About

The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence

Full description

Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.

Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recurrent pterygium
• Willingness to participate in research project and to attend research time
• At least 6 months after last pterygium surgery

Exclusion criteria

• Pregnant,breast-feeding women or poor general health
• Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
• Patients with allergy to mitomycin C,tobramycin or local anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Group CAG

Active Comparator group

Description:

After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then conjunctival autograft without limbal tissue will be used to cover the bare sclera.

Treatment:

Procedure: Conjunctival autograft

Procedure: Pterygium excision

Procedure: Intraoperative mitomycin C

Group LCAG

Active Comparator group

Description:

After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft will be used to cover the bare sclera.

Treatment:

Procedure: Limbal conjunctival autograft

Procedure: Pterygium excision

Procedure: Intraoperative mitomycin C