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| ID | Type | Description | Link |
|---|---|---|---|
| Benha University | Other Identifier | Al-Azhar University |
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aimed to compare the efficacy and safety of topical cyclosporin A (CsA) versus mitomycin C (MMC) as adjunctive therapies in preventing pterygium recurrence after surgical excision.
A total of 40 eyes from 40 patients undergoing pterygium surgery were randomized into two groups: Group A received topical cyclosporin A, while Group B was treated with topical mitomycin C. Ocular surface inflammation scores, recurrence rates, patient-reported symptoms, and adverse effects were assessed at baseline and during follow-up at 6 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (CsA Group) | Active Comparator | Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively. |
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| Group B (MMC Group) | Active Comparator | Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excision of the pterygium | Procedure | The surgical procedure involved excision of the pterygium, including the fibrovascular head and associated conjunctival tissue, followed by bare sclera closure using an autologous conjunctival graft harvested from the superior bulbar conjunctiva. The graft was secured in place using either fibrin glue or 8-0 absorbable sutures. In Group B, 0.02% mitomycin C (MMC) was applied to the bare sclera for two minutes using a soaked sponge, followed by thorough irrigation with balanced salt solution. |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence rate of pterygium | the recurrence rate of pterygium, defined as fibrovascular regrowth over the cornea of at least 1 mm | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in parameter OSDI (ocular surface disease index) from 0 to 100 points. | OSDI (from 0 to 100 points) where patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time" a final score is calculated which ranges from 0 to 100 with scores and based on their OSDI scores, patients can be categorized as having a normal ocular surface (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) ocular surface disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehab Saad, Lecturer | Benha University, Ebsar Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ebsar Eye Center | Cairo | Egypt | 4450113 | Egypt |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| Post-operative application of CsA | Drug | Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively. |
|
| Intra-operative application of MMC | Drug | 0.02% mitomycin C (MMC) was applied to the bare sclera for two minutes using a soaked sponge, followed by thorough irrigation with balanced salt solution. |
|
| 6 months after surgery |
| Change in clinical parameter Schirmer test (from 0 to 15 mm) | The Schirmer test score is determined by measuring the length of the strips' moistened area against fluid movement | 6 months after surgery |
| Change in clinical parameter (TBUT) | Change in clinical parameter Tear breakup time (TBUT) from less than 5 to more than 10 seconds | 6 months after surgery |