Comparative Analysis of Recurrence Rate Between Mini-Slet (Simple Limbal Epithelial Transplantation) Versus Limbal-Conjunctival Autograft Techniques in Primary Pterygium Excision
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Mexico
Instituto de oftalmología conde de Valenciana
RECRUITING
Mexico City
Contact Information
Primary
Enrique Graue Hernandez
egraueh@gmail.com
55 5442 1700
Backup
Nicolas Kahuam Lopez
nicolas.kahuaml@anahuac.mx
55 5442 1700
Time Frame
Start Date: 2024-06-22
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 68
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Instituto de Oftalmología Fundación Conde de Valenciana