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
1 other identifier
interventional
750
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedDecember 17, 2015
December 1, 2015
2 years
March 31, 2014
December 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of pterygium
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
One year
Secondary Outcomes (4)
Visual acuity
One year
Healing time of corneal epithelium
Four weeks
Healing time of conjunctival epithelium
Four weeks
Postoperative complications
One year
Study Arms (3)
MMC after pterygium excision
ACTIVE COMPARATORIntraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft.
AMT after Pterygium Excision
ACTIVE COMPARATORAmniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied.
CAG after Pterygium Excision
ACTIVE COMPARATORA conjunctival autograft will be harvested from the superior side of the operating eye's bulbar conjunctiva. Then the graft will be sutured to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied.
Interventions
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
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 head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
Eligibility Criteria
You may qualify if:
- Primary pterygium
- Willingness to participate in research project and to attend research follow-up
- Adults (age 18 to 80 years old)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Xi'an Eye Hospital
Xi’an, Shanxi, 710000, China
Sichuan Ganzi Autonomous Prefecture People's Hospital
Ganzi, Sichuan, 626000, China
The Fourth Affiliated Hospital, Kunming Medical University
Kunming, Yunnan, 650000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shiyou Zhou, M.D., Ph.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 3, 2014
Study Start
December 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
December 17, 2015
Record last verified: 2015-12