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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMC after pterygium excision | Active Comparator | Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft. |
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| AMT after Pterygium Excision | Active Comparator | Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. |
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| CAG after Pterygium Excision | Active Comparator | A 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMC | Procedure | Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of pterygium | Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | One year | |
| Healing time of corneal epithelium | Four weeks | |
| Healing time of conjunctival epithelium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyou Zhou, M.D., Ph.D. | Contact | 86-02087331540 | zhoushiy@mail.sysu.edu.cn | |
| Tao Zhou, M.D. | Contact | 86-18126813938 | taochou_tony@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiyou Zhou, M.D., Ph.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| AMT | Procedure | Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. |
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| CAG | Procedure | A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision. |
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| Pterygium excision | Procedure | Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue. |
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| Four weeks |
| Postoperative complications | One year |
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Xi'an Eye Hospital | Recruiting | Xi’an | Shanxi | 710000 | China |
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| Sichuan Ganzi Autonomous Prefecture People's Hospital | Recruiting | Ganzi | Sichuan | 626000 | China |
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| The Fourth Affiliated Hospital, Kunming Medical University | Recruiting | Kunming | Yunnan | 650000 | China |
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