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

• 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

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