Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium

Pterygium Clinical Trial

Official title:

Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02102776
• Other study ID #: 2014015
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2014
• Last updated: December 16, 2015
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: Sun Yat-sen University
• Contact: Shiyou Zhou, M.D., Ph.D.
• Phone: 86-02087331540
• Email: zhoushiy[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.

Description:

Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Primary pterygium

• Willingness to participate in research project and to attend research follow-up

• Adults (age 18 to 80 years old)

• Patients must not meet any of the following exclusion criteria

Exclusion Criteria:

• Pregnant,breast-feeding women or patients with poor general health

• Patients with significant ocular or lid pathology, such as Sjogren's Syndrome, infection, exposure keratitis, glaucoma, active uveitis, retinal detachment and trauma

• Patients with previous surgery on ocular surface, such as trabeculectomy, strabismus surgery

• Patients with allergy to intraoperative or postoperative drugs, such as mitomycin C, tobramycin or local anesthetics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• MMC
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
• AMT
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
• CAG
A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.
• Pterygium excision
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.

Locations

Country	Name	City	State
China	Sichuan Ganzi Autonomous Prefecture People's Hospital	Ganzi	Sichuan
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong
China	The Fourth Affiliated Hospital, Kunming Medical University	Kunming	Yunnan
China	Xi'an Eye Hospital	Xi'an	Shanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

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	Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag	One year	No
Secondary	Visual acuity		One year	No
Secondary	Healing time of corneal epithelium		Four weeks	No
Secondary	Healing time of conjunctival epithelium		Four weeks	No
Secondary	Postoperative complications		One year	No