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

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Enrolling

Conditions: Pterygium; Pterygium of Right Eye; Pterygium of Both Eyes; Pterygium of Left Eye

Treatments: Procedure: Pterygium Excision

Study type: Interventional

Funder types: Other

Identifiers

NCT06402643

CI-049-2023

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

68 participants in 2 patient groups

Mini-SLET.

Experimental group

Description:

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.

Treatment:

Procedure: Pterygium Excision

Conjunctival-Limbal Autograft.

Active Comparator group

Description:

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.

Treatment:

Procedure: Pterygium Excision