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OpenTrials
Completed

NCT Number: NCT03363282

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

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

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Key information

Conditions

Pterygium of Conjunctiva and Cornea

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary nasal pterygium > 2mm

Exclusion criteria

  • Pregnant
  • Previous ocular surgery

Treatment and study plan

Pterygium Excision

Procedure

Pterygium excision is the first step for repair

Other names: Limbal-Conjunctival Autograft, Mini-SLET

Primary outcomes

  1. Recurrence rate

    Time frame: one day

    Regrowth of pterygium

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 6, 2017
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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