Comparison of Recurrence Between Mini-SLET and Limbal-Conjunctival Autograft Techniques in Primary Pterygium
NCT ID: NCT06402643
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2024-06-22
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mini-SLET.
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.
Pterygium Excision
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.
Conjunctival-Limbal Autograft.
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.
Pterygium Excision
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.
Interventions
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Pterygium Excision
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.
Eligibility Criteria
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Inclusion Criteria
* Patients who can present and continue follow-up for the duration of the study
* Acceptance to participate in the study by signing the informed consent.
Exclusion Criteria
* Collagenopathy
* Pregnant
* Infection, conjunctival inflammation or ocular trauma
* Glaucoma
* Previous ocular surgery
18 Years
ALL
No
Sponsors
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Instituto de Oftalmología Fundación Conde de Valenciana
OTHER
Responsible Party
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Enrique Graue
Head of the Cornea and Refractive Surgery Department
Locations
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Instituto de oftalmología conde de Valenciana
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CI-049-2023
Identifier Type: -
Identifier Source: org_study_id
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