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Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases

Primary Purpose

Small Pupil, Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cana's Ring
Sponsored by
Santa Casa de Misericórdia de Belo Horizonte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Pupil focused on measuring Small pupil

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • clinical indication for cataract surgery, age of at least 18 years, pupil diameter less than 5mm after dilation with phenylephrine and tropicamide, and lens with any degree of opacity.

Exclusion Criteria:

  • eyes unable to perceive light during visual acuity testing, pupils with a diameter greater than 5mm and clear lenses

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cana's Ring group

    Arm Description

    The device Cana's Ring was used during cataract surgery on these patients.

    Outcomes

    Primary Outcome Measures

    Incidence of adverse events
    Safety of the material of the device from break, lesion of eye structures and iritis

    Secondary Outcome Measures

    Stability of the device during surgery
    Evaluate whether the device remains stable and attached to the iris during the entire surgery

    Full Information

    First Posted
    May 18, 2017
    Last Updated
    June 29, 2017
    Sponsor
    Santa Casa de Misericórdia de Belo Horizonte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03206983
    Brief Title
    Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases
    Official Title
    Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Santa Casa de Misericórdia de Belo Horizonte

    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 evaluate the intraoperative stability, safety and overall efficacy of the Canabrava Ring (AJL - SPAIN) when used to expand pupils with less diameter than 5 mm and pupils with sphincter synechiae.
    Detailed Description
    In this consecutive case series, 30 eyes of 29 patients underwent cataract surgery using a new disposable small-pupil expansion device, Canabrava's Ring (AJL Ophthalmic, Spain). It is the first iris expansion ring produced with indents that do not align with each other in the superior and inferior regions, resulting in a small vertical length (0.4mm) that minimizes risk of endothelial contact. All eyes had poorly preoperatively dilated pupils of less than 5mm. Fifteen eyes had significant infective or traumatic pathology preoperatively. Vertical and horizontal pupil diameters were evaluated pre-, intra- and 1 month postoperatively, and were used to calculate pupil circumference. Intraoperative and postoperative pupil circumference comprised the primary outcomes of interest.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Pupil, Cataract
    Keywords
    Small pupil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cana's Ring group
    Arm Type
    Experimental
    Arm Description
    The device Cana's Ring was used during cataract surgery on these patients.
    Intervention Type
    Device
    Intervention Name(s)
    Cana's Ring
    Intervention Description
    The device is used during cataract surgery to help dilate small pupils (under 5mm)
    Primary Outcome Measure Information:
    Title
    Incidence of adverse events
    Description
    Safety of the material of the device from break, lesion of eye structures and iritis
    Time Frame
    30 days after surgery
    Secondary Outcome Measure Information:
    Title
    Stability of the device during surgery
    Description
    Evaluate whether the device remains stable and attached to the iris during the entire surgery
    Time Frame
    During surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: clinical indication for cataract surgery, age of at least 18 years, pupil diameter less than 5mm after dilation with phenylephrine and tropicamide, and lens with any degree of opacity. Exclusion Criteria: eyes unable to perceive light during visual acuity testing, pupils with a diameter greater than 5mm and clear lenses
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sergio Canabrava, MD
    Organizational Affiliation
    Santa Casa de Misericórdia de Belo Horizonte
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases

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