Mini-simple limbal epithelial transplantation and conjunctival-limbal autograft for the treatment of primary pterygium: Study protocol for a randomized controlled trial
摘要
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.
Methods68 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.
DiscussionThis 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 registrationClinicalTrials.gov, NCT06402643. Registered on April 15, 2024.