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Corneal Transplantation Guided by OCT RESCAN

Primary Purpose

Cornea, Keratoconus, Bullous Keratopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumera Microscope with OCT RESCAN
Conventional Microscope
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cornea focused on measuring keratoconus, bullous keratopathy, corneal dystrophy

Eligibility Criteria

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

Inclusion Criteria:

  • Visual acuity less than 20/60 in the affected eye
  • 18 years at least
  • Diagnostic of the following diseases:

    • keratoconus
    • Keratopathy Bullosa
    • Corneal dystrophy

Exclusion Criteria:

  • Better visual acuity than or equal to 20/60

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lumera Microscope with OCT RESCAN

    Conventional Microscope

    Arm Description

    In the group microscope coupled to OCT, patients will undergo corneal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation

    The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation

    Outcomes

    Primary Outcome Measures

    Assess optimal maneuvers in corneal transplantation (separation layers)
    assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)

    Secondary Outcome Measures

    Compare the time of surgery between groups
    by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes)
    To describe the surgical difficulty for corneal transplantation
    by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
    Change of Day 1 Ocular inflammation at 1 month (Day 30)
    ocular inflammation scored as mild, moderate or severe
    Change from Baseline Intraocular Pressure at 6 months (Day180)
    intraocular pressure assessed by goldmann tonometer
    Change from Baseline Visual Acuity at 6 months (Day 180)
    visual acuity tested by ETDRS chart

    Full Information

    First Posted
    March 22, 2016
    Last Updated
    April 8, 2016
    Sponsor
    Federal University of São Paulo
    Collaborators
    Eye Clinic Day Hospital, São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02736877
    Brief Title
    Corneal Transplantation Guided by OCT RESCAN
    Official Title
    Corneal Transplantation Guided by OCT RESCAN: Pre-op, Intra-op and Post-op Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Eye Clinic Day Hospital, São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators will evaluate 30 patients with surgical indication for corneal transplantation. Participants will be divided according to the following diseases diseases: keratoconus, bullous keratopathy, corneal dystrophies. Participants will be informed about the risks and benefits of the study and sign an informed consent form. In the preoperative evaluation will be submitted to a complete ophthalmologic examination with complementary tests, such as optical coherence tomography. One group of participants will undergo corneal surgery using the OCT Lumera microscope RESCAN - ZEISS and another group with a conventional microscope. Everyone will have their filmed and documented surgery. The team of surgeons will answer the questionnaire on the surgical difficulty about the ease of assessing corneal transplantation. After surgery, participants will be assessed on days 1, 7,15, 30, 60, 90 and 180 after surgery. Surgeries and study procedures will be performed by the same team of surgeons and performed by IPEPO - Paulista Institute of Studies and Research in Ophthalmology / Vision Institute.
    Detailed Description
    Participants will be allocated in one of the following groups: Control Group The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1). Group OCT RESCAN In the group microscope coupled to OCT, patients will undergo retinal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation (ANNEX 1). The investigators will evaluate intraoperative conditions, complications, operative time and postoperative results in both groups. All patients will be monitored and evaluated with full ophthalmological examination in all postoperative visits (day 1, 7,15,30, 60, 90, 180) and will be subjected to the following tests: Measurement of visual acuity with best correction Previous Biomicroscopy Corneal Topography tonometry Optical coherence tomography (OCT) Microscopy speculate

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cornea, Keratoconus, Bullous Keratopathy, Corneal Dystrophy
    Keywords
    keratoconus, bullous keratopathy, corneal dystrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lumera Microscope with OCT RESCAN
    Arm Type
    Experimental
    Arm Description
    In the group microscope coupled to OCT, patients will undergo corneal surgery using the Lumera Microscope WITH RESCAN OCT - ZEISS. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation
    Arm Title
    Conventional Microscope
    Arm Type
    Active Comparator
    Arm Description
    The control group will undergo corneal transplant with conventional microscope without coupled OCT. The team of surgeons will answer the questionnaire on the surgical difficulty regarding corneal transplantation
    Intervention Type
    Procedure
    Intervention Name(s)
    Lumera Microscope with OCT RESCAN
    Intervention Description
    corneal transplantation guided by Lumera Microscope with OCT RESCAN
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional Microscope
    Intervention Description
    corneal transplantation guided by Conventional Microscope
    Primary Outcome Measure Information:
    Title
    Assess optimal maneuvers in corneal transplantation (separation layers)
    Description
    assessed by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
    Time Frame
    Day 0
    Secondary Outcome Measure Information:
    Title
    Compare the time of surgery between groups
    Description
    by a questionnaire responded by surgeons (until 30 minutes, between 30-60 minutes, more than 60 minutes)
    Time Frame
    Day 0
    Title
    To describe the surgical difficulty for corneal transplantation
    Description
    by a questionnaire responded by surgeons (no difficulty, some difficulty, very difficulty)
    Time Frame
    Day 0
    Title
    Change of Day 1 Ocular inflammation at 1 month (Day 30)
    Description
    ocular inflammation scored as mild, moderate or severe
    Time Frame
    from Day1 to Day30
    Title
    Change from Baseline Intraocular Pressure at 6 months (Day180)
    Description
    intraocular pressure assessed by goldmann tonometer
    Time Frame
    from Baseline to Day 180
    Title
    Change from Baseline Visual Acuity at 6 months (Day 180)
    Description
    visual acuity tested by ETDRS chart
    Time Frame
    from Baseline to Day 180

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Visual acuity less than 20/60 in the affected eye 18 years at least Diagnostic of the following diseases: keratoconus Keratopathy Bullosa Corneal dystrophy Exclusion Criteria: Better visual acuity than or equal to 20/60
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ricardo Nose, MD
    Phone
    5511 984471694
    Email
    ricnose@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luci Silva, PhD
    Phone
    +551155726443
    Email
    luci.silva@unifesp.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Walton Nose, MD, PhD
    Organizational Affiliation
    Federal University of São Paulo UNIFESP
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    scientific publication

    Learn more about this trial

    Corneal Transplantation Guided by OCT RESCAN

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