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| Name | Class |
|---|---|
| Irmandade Santa Casa de Misericórdia de Porto Alegre | OTHER |
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Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.
OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.
This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous fibrin glue | Experimental |
| |
| Sutures | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous fibrin glue | Other | Conjunctival graft fixation with autologous fibrin glue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pterygium Recurrence | Recurrence in 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Autograft Retraction | Graft detachment or retraction | Postoperative day 1, 7, 21 and 30 |
| Postoperative Pain | Presence Pain measured by a five-point scale, in which 0 means absence of symptom; 1 means easily tolerable symptom; 2 means symptom causing some discomfort; 3 means symptom partially interfering with usual activities and 4 means symptom completely interfering with usual activities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Marinho | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de Misericórdia | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36652022 | Derived | Cioba C, Marafon SB, Fortes BGB, Cavalheiro MT, Fabris M, Michel G, Zambon GM, Marcon A, Marinho DR. Autologous fibrin glue versus sutures for conjunctival autograft in primary pterygium: a randomized clinical trial. Int Ophthalmol. 2023 Jul;43(7):2371-2381. doi: 10.1007/s10792-023-02635-z. Epub 2023 Jan 18. |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Suture | Other | Graft fixation using 10.0 mononylon |
|
| Postoperative day 1, 7, 21 and 30 |
| Graft Edema | Graft edema (1-4). | Postoperative day 1, 7, 21 and 30 |