Mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: Study protocol for a randomized controlled trial.

BACKGROUND

Pterygium is a wing-shaped fibrovascular growth over the cornea that may require surgical removal due to recurrence and cosmetic concerns. This randomized controlled trial compares the recurrence rate of conjunctival-limbal autograft (CLAu) with a modified mini-simple limbal epithelial transplant (mini-SLET) technique.

METHODS

68 patients will be randomly assigned to two equally sized groups via simple randomization. Group I will undergo a pterygium excision with CLAu, while Group II will undergo a pterygium excision using a mini-SLET. Allocation concealment will be ensured using sealed envelopes, and procedures will be performed by two surgeons. Patients will be followed postoperatively at regular intervals for up to 12 months.

DISCUSSION: This study builds on previous research by modifying the mini-SLET technique to enhance corneal stem cell viability and reduce recurrence. By refining this method, we aim to offer patients a more effective and minimally invasive alternative to the gold-standard procedure.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT06402643. Registered on April 15, 2024.