Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision

Pterygium of Conjunctiva and Cornea Clinical Trial

Official title:

Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363282
• Other study ID #: CI-021-2015
• Status: Completed
• Phase: N/A
• First received: November 30, 2017
• Last updated: March 7, 2018
• Start date: September 17, 2015
• Est. completion date: November 28, 2017

Study information

• Verified date: March 2018
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft

Description:

Prospective Randomized Blind Clinical Trial

Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.

Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 28, 2017
• Est. primary completion date: November 17, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with primary nasal pterygium > 2mm

Exclusion Criteria:

• Pregnant

• Previous ocular surgery

Related Conditions & MeSH terms

• Pterygium
• Pterygium of Conjunctiva and Cornea
• Recurrence

Intervention

Procedure:
• Pterygium Excision
Pterygium excision is the first step for repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

References & Publications (3)

Küçükerdönmez C, Akova YA, Altinörs DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. — View Citation

Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004 Jul;23(5):458-63. — View Citation

Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Regrowth of pterygium	one day