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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03363282
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

Brief 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

Condition or disease Intervention/treatment Phase
Pterygium of Conjunctiva and Cornea Procedure: Pterygium Excision Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : November 17, 2016
Actual Study Completion Date : November 28, 2017

Arm Intervention/treatment
Experimental: Mini-SLET
Simple Limbal Epithelial Transplantation
Procedure: Pterygium Excision
Pterygium excision is the first step for repair
Other Names:
  • Limbal-Conjunctival Autograft
  • Mini-SLET

Experimental: Limbal-Conjunctival Autograft
Patients treated with limbal-conjunctival autograft
Procedure: Pterygium Excision
Pterygium excision is the first step for repair
Other Names:
  • Limbal-Conjunctival Autograft
  • Mini-SLET

Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: one day ]
    Regrowth of pterygium

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with primary nasal pterygium > 2mm

Exclusion Criteria:

  • Pregnant
  • Previous ocular surgery
Publications of Results:
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Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana Identifier: NCT03363282    
Other Study ID Numbers: CI-021-2015
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data will be analyzed by a single researcher

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Conjunctival Diseases
Eye Diseases