Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C
NCT ID: NCT04463901
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
116 participants
INTERVENTIONAL
2016-02-29
2021-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group CAG
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.
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.
Group LCAG
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.
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.
Limbal conjunctival autograft
A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to participate in research project and to attend research time
* At least 6 months after last pterygium surgery
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Shiyou Zhou
MD,PhD
Principal Investigators
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Zhou Shiyou, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20150527
Identifier Type: -
Identifier Source: org_study_id
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