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The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction after excision of pterygium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal epithelial autograft | Experimental | pterygium resection combined with femtosecond laser assisted corneal epithelial autograft |
|
| Limbal conjunctival autograft | Active Comparator | pterygium resection combined with diamond knife assisted limbal conjunctival autograft |
|
| Simple removal | Active Comparator | Simple removal of pterygium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal epithelial autograft | Procedure | After removal of the recipient's pterygium tissue, a donor epithelial tissue equal in length to the bared limbus, will be obtained from the peripheral epithelial of the same eye (corneal epithelial autograft) using femtosecond laser technology. The epithelial graft will be sutured to the recipient limbal bed, with the goal of reconstruction of palisades of Vogt. The graft will act as a barrier to regrowth of pterygium. The area of the graft will be left with the Tenon capsule exposed. |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of corneal surface | Restoration of a completely epithelized, stable, and avascular corneal surface | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of pterygium | To observe recurrence of pterygium using slit-lamp microscopy | 1 year |
| Reconstruction of palisades of Vogt | To observe the reconstruction of palisades of Vogt using in vivo confocal microscopy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingfeng Zheng, M.D.Ph.D. | Contact | +8613922286455 | yingfeng.zheng@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu, M.D.Ph.D. | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Ting Huang, 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 Univerisity | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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|
| Limbal conjunctival autograft | Procedure | After removal of the recipient's pterygium tissue, an adjustable diamond knife will be used to create a superficial circumferential incision at the corneal end of the limbal vascular arcade, equal in length to the bared limbus. This will be followed by harvesting the limbal-conjunctival flap. The limbal-conjunctival autograft will be sutured to the recipient bed, with the Tenon capsule exposed. The graft will serve as a barrier to regrowth of pterygium. |
|
| Simple removal | Procedure | Simple removal of the recipient's pterygium tissue, with the Tenon capsule exposed. |
|
| Diamond knife | Device | A diamond knife to create a particular shaped limbal graft for transplantation |
|
| Femtosecond laser | Device | A commercial femtosecond laser to create a particular shaped graft for transplantation |
|
| 1 year |
| Best corrected visual acuity | To assess changes of best corrected visual acuity using ETDRS chart | 1 year |
| Corneal power and astigmatism | To assess changes of corneal power and astigmatism using autorefractor keratometer | 1 year |
| Corneal haze measurement | To observe the scatter of corneal haze using in vivo confocal microscopy | 1 year |