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

May 6, 2024 updated by: Enrique Graue, Instituto de Oftalmología Fundación Conde de Valenciana

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 06800
        • Recruiting
        • Instituto de Oftalmología Conde de Valenciana
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 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.
1 month, 3, months, 6 months and 12 months after surgery.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-049-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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