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

Not Applicable

• Conditions: Recurrent Pterygium
• Interventions: Procedure: Pterygium excision; Procedure: Intraoperative mitomycin C; Procedure: Conjunctival autograft; Procedure: Limbal conjunctival autograft

• Registration Number: NCT04463901
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-02
• Status Verified: 2020-07
• Study First Submitted: 2020-07-04
• Study First Submitted QC: 2020-07-04
• Last Update Submitted: 2020-07-04
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group CAG	Conjunctival autograft	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.
Group LCAG	Pterygium excision	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.
Group CAG	Intraoperative mitomycin C	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.
Group CAG	Pterygium excision	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.
Group LCAG	Intraoperative mitomycin C	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.
Group LCAG	Limbal conjunctival autograft	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.

Primary Outcome Measures

Name	Time	Method
Recurrence of pterygium	One year

Secondary Outcome Measures

Name	Time	Method
Visual acuity	One year
Healing time of corneal epithelium	Four weeks
Healing time of conjunctival epithelium	Four weeks
Postoperative complications	One year

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China