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

I

Instituto de Oftalmología Fundación Conde de Valenciana

Status

Completed

Conditions

Pterygium of Conjunctiva and Cornea

Treatments

Procedure: Pterygium Excision

Study type

Interventional

Funder types

Other

Identifiers

NCT03363282
CI-021-2015

Details and patient eligibility

About

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

Full 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.

Enrollment

57 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with primary nasal pterygium > 2mm

Exclusion criteria

  • Pregnant
  • Previous ocular surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

57 participants in 2 patient groups

Mini-SLET
Experimental group
Description:
Simple Limbal Epithelial Transplantation
Treatment:
Procedure: Pterygium Excision
Limbal-Conjunctival Autograft
Experimental group
Description:
Patients treated with limbal-conjunctival autograft
Treatment:
Procedure: Pterygium Excision

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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