NCT02102776

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pterygium

Interventions

Type	Name	Description
PROCEDURE	MMC	Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
PROCEDURE	AMT	Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
PROCEDURE	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.
PROCEDURE	Pterygium excision	Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-04-03
• Last updated: 2015-12-17

Locations

5 sites across 1 country: China