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The surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
The surgical treatment options for pterygium, an abnormal growth on the eye's surface, encompass various approaches. These include standard surgical excision, which involves removing the pterygium using traditional surgical methods and more recently Simple Limbal Epithelial Transplantation. Recurrence rate of pterygium varies depending on the surgical technique employed and other factors related to the patient and surgery.The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini-SLET. | Experimental | In addition to the standard resection technique, the surgical procedure will include the application of AM with surgical adhesive at the surgical site. Following this, limbal cells will be harvested from the limbus in a resection measuring 2×2 mm, divided into six fragments, and positioned along the limbus border on the AM. |
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| Conjunctival-Limbal Autograft. | Active Comparator | Pterygium will be surgically removed utilizing conventional resection techniques, entailing a blunt resection of the head, neck, and body of the pterygium. Subsequent to the resection, the surgical site will be polished using a surgical diamond burr if deemed necessary, and hemostasis will be achieved using bipolar cautery. In the case of CLAu, an autograft will be procured from the superior temporal bulbar conjunctiva. The autograft will be fixed to the surgical site using surgical adhesive. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pterygium Excision | Procedure | Pterygium will be surgically removed utilizing conventional resection techniques, entailing a blunt resection of the head, neck, and body of the pterygium. Subsequent to the resection, the surgical site will be polished using a surgical diamond burr if deemed necessary, and hemostasis will be achieved using bipolar cautery. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Any fibrovascular growth that passes onto the cornea across the limbus, will be considered a recurrence. | 1 month, 3, months, 6 months and 12 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative symptoms | Any postoperative symptoms, such as: pain, foreign body sensation, irritation, and tearing. | 1 month, 3, months, 6 months and 12 months after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrique Graue Hernandez | Contact | 55 5442 1700 | egraueh@gmail.com | |
| Nicolas Kahuam Lopez | Contact | 55 5442 1700 | nicolas.kahuaml@anahuac.mx |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de oftalmologÃa conde de Valenciana | Recruiting | Mexico City | 06800 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41174752 | Derived | Vera-Duarte GR, Ortiz-Morales G, Muller-Morales CA, Navas A, Ramirez-Miranda A, Graue-Hernandez EO, Kahuam-Lopez N. Mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: Study protocol for a randomized controlled trial. Trials. 2025 Oct 31;26(1):457. doi: 10.1186/s13063-025-09075-3. |
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The allocation sequence will be generated by an investigator and will
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The allocation of the study participants will be concealed in opaque envelopes.
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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