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

Pterygium Clinical Trial

Official title:

Comparative Analysis of Recurrence Rate Between Mini-Slet (Simple Limbal Epithelial Transplantation) Versus Limbal-Conjunctival Autograft Techniques in Primary Pterygium Excision

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402643
• Other study ID #: CI-049-2023
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: Enrique Graue Hernandez
• Phone: 55 5442 1700
• Email: egraueh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pterygium
• Pterygium of Both Eyes
• Recurrence

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Mexico	Instituto de oftalmología conde de Valenciana	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Any fibrovascular growth that passes onto the cornea across the limbus, will be considered a recurrence.	1 month, 3, months, 6 months and 12 months after surgery.
Secondary	Postoperative symptoms	Any postoperative symptoms, such as: pain, foreign body sensation, irritation, and tearing.	1 month, 3, months, 6 months and 12 months after surgery.