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Comparative Study of Muc5ac and Muc2 Mucins in Tear Film Concentration in Surgical Treated Pterygia Patients

Primary Purpose

Pterygium of Both Eyes

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

About this trial

This is an interventional screening trial for Pterygium of Both Eyes focused on measuring pterygium, amniotic membrane, conjunctival autograft, ocular mucin

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with nasal, primary pterygium bigger than 1 mm.

Exclusion Criteria:

  • Diabetes mellitus, single eye.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Amniotic membrane transplantation

    conjnctival autograft.

    Arm Description

    Amniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery.

    Conjunctival autograft was used as a covering material in the area where the pterygium tissue was removed during the surgery.

    Outcomes

    Primary Outcome Measures

    Ocular Tear film Mucin MUC5ac concentration.
    Using a capillary tube, tear film was collected en every patient. Then Concentration of mucin MUC5ac were measured by Elisa technique using a quantitative scale.
    Ocular tear film Mucin MUC2 concentration.
    Using a capillary tube, tear film was collected en every patient. Then Concentration of mucin MUC2 were measured by Elisa technique using a quantitative scale.
    Tear film breakup time.
    Tear film breakup time is the time between a complete blink and the appearance of the first random corneal dry spot and indicates relative tear film stability.

    Secondary Outcome Measures

    Pterygium recurrence.
    Pterygium recurrence was defined as any fibrovascular proliferation from the original pterygium site from it was surgically removed.

    Full Information

    First Posted
    April 29, 2020
    Last Updated
    May 7, 2020
    Sponsor
    Instituto de Oftalmología Fundación Conde de Valenciana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04385446
    Brief Title
    Comparative Study of Muc5ac and Muc2 Mucins in Tear Film Concentration in Surgical Treated Pterygia Patients
    Official Title
    Comparative Study of Concentration of Muc5ac and Muc2 Mucins in Tear Film in Surgical Treated Pterygia With Amniotic Membrane Transplantation vs. Conjunctival Autograft
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2, 2016 (Actual)
    Primary Completion Date
    February 7, 2017 (Actual)
    Study Completion Date
    September 5, 2018 (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
    No

    5. Study Description

    Brief Summary
    To identify and compare the differences in the concentration of the Muc2 and Muc5AC mucins in tear film in patients who underwent pterygium surgery using amniotic membrane transplantation and conjunctival autograft surgery.
    Detailed Description
    Patients with nasal, primary pterygium bigger than 1 mm of corneal invasion with residence in Mexico City and older than 18 years were included. Under informed consent, patients were divided into two groups in a random fashion. Pterygium surgery was carried out with conventional technique performing amniotic membrane transplantation for group A, and conjunctival autograft for group B. Muc2 and muc5ac mucin concentration was measure min tear film by ELISA; samples were taken before surgery, at first, third and sixth month postoperatively. BUT was also measured on the same dates. Descriptive statistics and the U-Mann Whitney test for independent groups, considering a p≤0.05 as significant were used for analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pterygium of Both Eyes
    Keywords
    pterygium, amniotic membrane, conjunctival autograft, ocular mucin

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups of patients in whom Conventional Pterygium surgery was performed Each patient was randomly assigned for either received amniotic membrane transplantation or conjunctival autograft as a recovering method in the pterygium removed area after surgery. Tear film Mucins were measured in both groups
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The patients did not know what kind of material was used in their surgery. The assessor who performed tear film analysis did not know what material was used in the patient.
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Amniotic membrane transplantation
    Arm Type
    Active Comparator
    Arm Description
    Amniotic membrane transplantation was used as covering material in the area where the pterygium tissue was removed during the surgery.
    Arm Title
    conjnctival autograft.
    Arm Type
    No Intervention
    Arm Description
    Conjunctival autograft was used as a covering material in the area where the pterygium tissue was removed during the surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Amniotic membrane transplantation
    Intervention Description
    Amniotic membrane transplantation was used as covering material during pterygium surgery.
    Primary Outcome Measure Information:
    Title
    Ocular Tear film Mucin MUC5ac concentration.
    Description
    Using a capillary tube, tear film was collected en every patient. Then Concentration of mucin MUC5ac were measured by Elisa technique using a quantitative scale.
    Time Frame
    The patients will be assed during six months
    Title
    Ocular tear film Mucin MUC2 concentration.
    Description
    Using a capillary tube, tear film was collected en every patient. Then Concentration of mucin MUC2 were measured by Elisa technique using a quantitative scale.
    Time Frame
    The patients will be assed during six months
    Title
    Tear film breakup time.
    Description
    Tear film breakup time is the time between a complete blink and the appearance of the first random corneal dry spot and indicates relative tear film stability.
    Time Frame
    The patients will be assed during six months
    Secondary Outcome Measure Information:
    Title
    Pterygium recurrence.
    Description
    Pterygium recurrence was defined as any fibrovascular proliferation from the original pterygium site from it was surgically removed.
    Time Frame
    The patients will be assed during six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with nasal, primary pterygium bigger than 1 mm. Exclusion Criteria: Diabetes mellitus, single eye.

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Study of Muc5ac and Muc2 Mucins in Tear Film Concentration in Surgical Treated Pterygia Patients

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