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

Primary Purpose

Pterygium of Conjunctiva and Cornea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pterygium Excision
Sponsored by
Instituto de Oftalmología Fundación Conde de Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium of Conjunctiva and Cornea focused on measuring Crosslinking

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with primary nasal pterygium > 2mm

Exclusion Criteria:

  • Pregnant
  • Previous ocular surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Mini-SLET

    Limbal-Conjunctival Autograft

    Arm Description

    Simple Limbal Epithelial Transplantation

    Patients treated with limbal-conjunctival autograft

    Outcomes

    Primary Outcome Measures

    Recurrence rate
    Regrowth of pterygium

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2017
    Last Updated
    March 7, 2018
    Sponsor
    Instituto de Oftalmología Fundación Conde de Valenciana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03363282
    Brief Title
    Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
    Official Title
    Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 17, 2015 (Actual)
    Primary Completion Date
    November 17, 2016 (Actual)
    Study Completion Date
    November 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Oftalmología Fundación Conde de Valenciana

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pterygium of Conjunctiva and Cornea
    Keywords
    Crosslinking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mini-SLET
    Arm Type
    Experimental
    Arm Description
    Simple Limbal Epithelial Transplantation
    Arm Title
    Limbal-Conjunctival Autograft
    Arm Type
    Experimental
    Arm Description
    Patients treated with limbal-conjunctival autograft
    Intervention Type
    Procedure
    Intervention Name(s)
    Pterygium Excision
    Other Intervention Name(s)
    Limbal-Conjunctival Autograft, Mini-SLET
    Intervention Description
    Pterygium excision is the first step for repair
    Primary Outcome Measure Information:
    Title
    Recurrence rate
    Description
    Regrowth of pterygium
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with primary nasal pterygium > 2mm Exclusion Criteria: Pregnant Previous ocular surgery

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Patient data will be analyzed by a single researcher
    Citations:
    PubMed Identifier
    2695347
    Citation
    Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. doi: 10.1038/eye.1989.22.
    Results Reference
    result
    PubMed Identifier
    15220729
    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. doi: 10.1097/01.ico.0000116522.57227.97.
    Results Reference
    result
    PubMed Identifier
    17457187
    Citation
    Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.
    Results Reference
    result

    Learn more about this trial

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

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