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

NCT06402643 | Recruiting DMC

• 1 other identifier: CI-049-2023
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pterygium,; Mini-SLET; Conjunctival-Limbal autograft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative symptoms

  1 month, 3, months, 6 months and 12 months after surgery.

Study Arms (2)

Mini-SLET.

EXPERIMENTAL

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.

Procedure: Pterygium Excision

Conjunctival-Limbal Autograft.

ACTIVE COMPARATOR

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.

Procedure: Pterygium Excision

Interventions

Pterygium Excision PROCEDURE

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.

Conjunctival-Limbal Autograft.; Mini-SLET.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with rheumatoid arthritis
• Collagenopathy
• Pregnant
• Infection, conjunctival inflammation or ocular trauma
• Glaucoma
• Previous ocular surgery

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de oftalmología conde de Valenciana

Mexico City, 06800, Mexico

RECRUITING

Related Publications (1)

• Vera-Duarte GR, Ortiz-Morales G, Muller-Morales CA, Navas A, Ramirez-Miranda A, Graue-Hernandez EO, Kahuam-Lopez N. Mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: Study protocol for a randomized controlled trial. Trials. 2025 Oct 31;26(1):457. doi: 10.1186/s13063-025-09075-3.

  PMID: 41174752 DERIVED

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Central Study Contacts

Enrique Graue Hernandez

CONTACT

55 5442 1700; egraueh@gmail.com

Nicolas Kahuam Lopez

CONTACT

55 5442 1700; nicolas.kahuaml@anahuac.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation of the study participants will be concealed in opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Cornea and Refractive Surgery Department

Model Details: The allocation sequence will be generated by an investigator and will

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 7, 2024
• Study Start: June 22, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)