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

Not Applicable

Recruiting

• Conditions: Pterygium of Right Eye; Pterygium; Pterygium of Left Eye; Pterygium of Both Eyes
• Interventions: Procedure: Pterygium Excision

• Registration Number: NCT06402643
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-04-15
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07
• Study Start: 2024-06-22
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini-SLET.	Pterygium Excision	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.
Conjunctival-Limbal Autograft.	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. 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.

Primary Outcome Measures

Name	Time	Method
Recurrence rate	1 month, 3, months, 6 months and 12 months after surgery.	Any fibrovascular growth that passes onto the cornea across the limbus, will be considered a recurrence.

Secondary Outcome Measures

Name	Time	Method
Postoperative symptoms	1 month, 3, months, 6 months and 12 months after surgery.	Any postoperative symptoms, such as: pain, foreign body sensation, irritation, and tearing.

Trial Locations

Locations (1)

Instituto de oftalmología conde de Valenciana; 🇲🇽 Mexico City, Mexico