Comparison of Recurrence Between Mini-SLET and Limbal-Conjunctival Autograft Techniques in Primary Pterygium

NCT ID: NCT06402643

Last Updated: 2024-05-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-22

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pterygium of Right Eye Pterygium of Left Eye Pterygium of Both Eyes Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The allocation sequence will be generated by an investigator and will
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The allocation of the study participants will be concealed in opaque envelopes.

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.

Group Type EXPERIMENTAL

Pterygium Excision

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Pterygium Excision

Intervention Type 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.

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with primary nasal pterygium \> 2mm
* 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

* Patients with rheumatoid arthritis
* Collagenopathy
* Pregnant
* Infection, conjunctival inflammation or ocular trauma
* Glaucoma
* Previous ocular surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role lead

Responsible Party

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Enrique Graue

Head of the Cornea and Refractive Surgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto de oftalmología conde de Valenciana

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Enrique Graue Hernandez

Role: CONTACT

55 5442 1700

Nicolas Kahuam Lopez

Role: CONTACT

55 5442 1700

Facility Contacts

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Enrique Graue Hernandez

Role: primary

+52 5554421700 ext. 3710

Nicolas Kahuam Lopez

Role: backup

+52 5554421700 ext. 3710

Other Identifiers

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CI-049-2023

Identifier Type: -

Identifier Source: org_study_id

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