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

Recurrent Pterygium Clinical Trial

Official title:

Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463901
• Other study ID #: 20150527
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2021

Study information

• Verified date: July 2020
• Source: Sun Yat-sen University
• Contact: Zhou Shiyou, M.D., Ph.D.
• Phone: 86-02087331540
• Email: zhoushiy[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pterygium
• Recurrent Pterygium

Intervention

Procedure:
• Pterygium excision
Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
• Intraoperative mitomycin C
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
• Conjunctival autograft
A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
• Limbal conjunctival autograft
A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of pterygium		One year
Secondary	Visual acuity		One year
Secondary	Healing time of corneal epithelium		Four weeks
Secondary	Healing time of conjunctival epithelium		Four weeks
Secondary	Postoperative complications		One year