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The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

Primary Purpose

Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cochet bonnet esthesiometer
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pterygium focused on measuring Cochet bonnet esthesiometer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients that suppose to undergo pterigyum surgery

Exclusion Criteria:

  • Patients with anterior segment diseases Patients that underwent anterior segment surgeries Patients with 7th nerve palsy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cochet bonnet esthesiometer

    Arm Description

    To examine sensation

    Outcomes

    Primary Outcome Measures

    To sensation before and after pterygium surgeries as measured by Cochet bonnet esthesiometer
    The change in sensation in the cornea and conjunctiva after pterygium surgery as measured by Cochet bonnet esthesiometer

    Secondary Outcome Measures

    To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery
    Dry eye will be measured by Tear break up time
    To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery
    Dry eye will be measured by Schrimer test
    To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery
    Dry eye will be measured by lissamine green test
    To examine the change in visual acuity that may predicate the change in sensation after pterygium surgery
    Visual acuity will be measured by Snellen chart
    To examine the change in refraction that may predicate the change in sensation after pterygium surgery:
    Refraction will be measured by autorefractometer
    To examine the change in anterior chamber that may predicate the change in sensation after pterygium surgery:
    Anterior chamber slit lamp examination
    To examine the change in imaging of anterior segment that may predicate the change in sensation after pterygium surgery:
    Anterior Chamber Optical coherence tomography( AC-OCT)
    To examine the Recurrence of pterygium
    Recurrence of pterygium as examined in slit lamp examination

    Full Information

    First Posted
    October 9, 2017
    Last Updated
    April 20, 2018
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03314389
    Brief Title
    The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries
    Official Title
    The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2018 (Anticipated)
    Primary Completion Date
    January 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheba Medical Center

    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
    The purpose of this current study is to examine the sensation of the corneal and conjunctiva sensation before and after pterygium surgeries by Cochet bonnet esthesiometer and to examine epidemiological, clinical and imaging factors the influence the sensation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pterygium
    Keywords
    Cochet bonnet esthesiometer

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cochet bonnet esthesiometer
    Arm Type
    Experimental
    Arm Description
    To examine sensation
    Intervention Type
    Device
    Intervention Name(s)
    Cochet bonnet esthesiometer
    Intervention Description
    Cochet bonnet esthesiometer- To examine sensation
    Primary Outcome Measure Information:
    Title
    To sensation before and after pterygium surgeries as measured by Cochet bonnet esthesiometer
    Description
    The change in sensation in the cornea and conjunctiva after pterygium surgery as measured by Cochet bonnet esthesiometer
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Secondary Outcome Measure Information:
    Title
    To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery
    Description
    Dry eye will be measured by Tear break up time
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Title
    To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery
    Description
    Dry eye will be measured by Schrimer test
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Title
    To examine the change in dry eye syndrome that may predicate the change in sensation after pterygium surgery
    Description
    Dry eye will be measured by lissamine green test
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Title
    To examine the change in visual acuity that may predicate the change in sensation after pterygium surgery
    Description
    Visual acuity will be measured by Snellen chart
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Title
    To examine the change in refraction that may predicate the change in sensation after pterygium surgery:
    Description
    Refraction will be measured by autorefractometer
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Title
    To examine the change in anterior chamber that may predicate the change in sensation after pterygium surgery:
    Description
    Anterior chamber slit lamp examination
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Title
    To examine the change in imaging of anterior segment that may predicate the change in sensation after pterygium surgery:
    Description
    Anterior Chamber Optical coherence tomography( AC-OCT)
    Time Frame
    Before surgery compare to one week+ one month+three months after surgery
    Title
    To examine the Recurrence of pterygium
    Description
    Recurrence of pterygium as examined in slit lamp examination
    Time Frame
    one week+ one month+three months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients that suppose to undergo pterigyum surgery Exclusion Criteria: Patients with anterior segment diseases Patients that underwent anterior segment surgeries Patients with 7th nerve palsy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ofra Zloto, MD
    Phone
    972-54-6516220
    Email
    ozloto@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22081668
    Citation
    Sakarya Y, Sakarya R, Kara S. Reversal of sensation of conjunctival autograft after pterygium surgery. Eur J Ophthalmol. 2012;22 Suppl 7:S11-6. doi: 10.5301/ejo.5000082.
    Results Reference
    result
    PubMed Identifier
    27362880
    Citation
    Julio G, Campos P, Pujol P, Munguia A, Mas-Aixala E. Determining Factors for Fast Corneal Sensitivity Recovery After Pterygium Excision. Cornea. 2016 Dec;35(12):1594-1599. doi: 10.1097/ICO.0000000000000932.
    Results Reference
    result
    PubMed Identifier
    25833130
    Citation
    Pujol P, Julio G, Barbany M, Asaad M. Healing indicators after pterygium excision by optical coherence tomography. Ophthalmic Physiol Opt. 2015 May;35(3):308-14. doi: 10.1111/opo.12206. Epub 2015 Mar 31.
    Results Reference
    result

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    The Corneal and Conjunctiva Sensation Before and After Pterygium Surgeries

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