search
Back to results

Cataract Surgery Technique and Ocular Clarity

Primary Purpose

Cataract

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery with Centurion phacoemulsification system
cataract surgery with Quatera 700 phacoemulsification system
Sponsored by
Amphia Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Straylight, Phacoemulsification, Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of cataract in both eyes,
  • Having consented to and is planned to undergo cataract surgery in both eyes,
  • Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
  • A targeted refractive error of emmetropia,
  • Corneal astigmatism of ≤1.5 D,
  • Age of at least 18 years,
  • Willing and able to participate in both preoperative and postoperative examinations, and
  • Agreeing to sign the informed consent form.

Exclusion Criteria:

  • Insufficient understanding of the Dutch language to comply with study procedures,
  • Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
  • Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
  • Subjects with an increased risk of complicated cataract surgery:
  • Lens subluxation or (phaco)iridodonesis,
  • Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and
  • History of ocular trauma,
  • Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and
  • A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Centurion

    Quatera 700

    Arm Description

    Cataract surgery performed with the Centurion phacoemulsification system

    Cataract surgery performed with the Quatera 700 phacoemulsification system

    Outcomes

    Primary Outcome Measures

    Straylight
    Amount of straylight measured with C-Quant, expressed as log(s)
    Straylight
    Amount of straylight measured with C-Quant, expressed as log(s)
    Straylight
    Amount of straylight measured with C-Quant, expressed as log(s)
    Straylight
    Amount of straylight measured with C-Quant, expressed as log(s)
    Straylight
    Amount of straylight measured with C-Quant, expressed as log(s)

    Secondary Outcome Measures

    Corneal densitometry
    Corneal densitometry measured with Pentacam, expressed as percentage
    Corneal densitometry
    Corneal densitometry measured with Pentacam, expressed as percentage
    Corneal densitometry
    Corneal densitometry measured with Pentacam, expressed as percentage
    Corneal densitometry
    Corneal densitometry measured with Pentacam, expressed as percentage
    Corneal densitometry
    Corneal densitometry measured with Pentacam, expressed as percentage
    Amount of phaco energy used
    Amount of phaco energy used, expressed as Cumulative Dissipated Energy (CDE, for Alcon Centurion) or as Equivalent Phaco Time (EPT, for Zeiss Quatera 700)
    Amount of balanced salt solution used
    Amount of balanced salt solution used, expressed in milliliters
    Total surgery time
    Total surgery time per eye
    Uncorrected Distance Visual Acuity
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Uncorrected Distance Visual Acuity
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Uncorrected Distance Visual Acuity
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Uncorrected Distance Visual Acuity
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Uncorrected Distance Visual Acuity
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Corrected Distance Visual Acuity
    Corrected Distance Visual Acuity, expressed as logMAR
    Corrected Distance Visual Acuity
    Corrected Distance Visual Acuity, expressed as logMAR
    Corrected Distance Visual Acuity
    Corrected Distance Visual Acuity, expressed as logMAR
    Corneal pachymetry
    Corneal thickness measured with Pentacam, expressed as um
    Corneal pachymetry
    Corneal thickness measured with Pentacam, expressed as um
    Corneal pachymetry
    Corneal thickness measured with Pentacam, expressed as um
    Corneal pachymetry
    Corneal thickness measured with Pentacam, expressed as um
    Corneal pachymetry
    Corneal thickness measured with Pentacam, expressed as um
    Presence of corneal oedema
    Presence of corneal oedema with slit lamp biomicroscopy
    Presence of corneal oedema
    Presence of corneal oedema with slit lamp biomicroscopy
    Presence of corneal oedema
    Presence of corneal oedema with slit lamp biomicroscopy
    Presence of corneal oedema
    Presence of corneal oedema with slit lamp biomicroscopy
    Presence of corneal oedema
    Presence of corneal oedema with slit lamp biomicroscopy
    Catquest-9SF
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Catquest-9SF
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Catquest-9SF
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Catquest-9SF
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Catquest-9SF
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Patient-Perceived Satisfactory Improvement in Vision
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
    Patient-Perceived Satisfactory Improvement in Vision
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
    Patient-Perceived Satisfactory Improvement in Vision
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
    Patient-Perceived Satisfactory Improvement in Vision
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)

    Full Information

    First Posted
    July 29, 2022
    Last Updated
    August 3, 2022
    Sponsor
    Amphia Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05489198
    Brief Title
    Cataract Surgery Technique and Ocular Clarity
    Official Title
    Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Amphia Hospital

    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
    The goal of this study is to study the restoration of quality of vision, expressed as straylight, in the immediate period after cataract surgery with two different phacoemulsification technologies.
    Detailed Description
    Cataract is an opacification of the lens. With cataract surgery, the lens is surgically removed after which a clear artificial intraocular lens is implanted. For patients, it is important that they regain functional vision as quickly as possible after surgery as a limited vision may increase the risk of falling and increases the dependency on other people. Surgical removal of the lens is done with a phacoemulsification system. Differences between phacoemulsification systems are the used pump type, the way the needle oscillates, and the fluid dynamics of the system. It is unknown whether any of the available systems offer an advantage on the amount of corneal oedema that develops after surgery and, therefore, results in a more rapid restoration of functional vision.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract
    Keywords
    Straylight, Phacoemulsification, Cataract

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, comparative, single-arm, randomised, and single-centre study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Centurion
    Arm Type
    Experimental
    Arm Description
    Cataract surgery performed with the Centurion phacoemulsification system
    Arm Title
    Quatera 700
    Arm Type
    Experimental
    Arm Description
    Cataract surgery performed with the Quatera 700 phacoemulsification system
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery with Centurion phacoemulsification system
    Intervention Description
    Cataract surgery performed with the Centurion phacoemulsification system
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery with Quatera 700 phacoemulsification system
    Intervention Description
    Cataract surgery performed with the Quatera 700 phacoemulsification system
    Primary Outcome Measure Information:
    Title
    Straylight
    Description
    Amount of straylight measured with C-Quant, expressed as log(s)
    Time Frame
    preoperative
    Title
    Straylight
    Description
    Amount of straylight measured with C-Quant, expressed as log(s)
    Time Frame
    1-2 hours after surgery
    Title
    Straylight
    Description
    Amount of straylight measured with C-Quant, expressed as log(s)
    Time Frame
    1 day after surgery
    Title
    Straylight
    Description
    Amount of straylight measured with C-Quant, expressed as log(s)
    Time Frame
    1 week after surgery
    Title
    Straylight
    Description
    Amount of straylight measured with C-Quant, expressed as log(s)
    Time Frame
    1 month after surgery
    Secondary Outcome Measure Information:
    Title
    Corneal densitometry
    Description
    Corneal densitometry measured with Pentacam, expressed as percentage
    Time Frame
    preoperative
    Title
    Corneal densitometry
    Description
    Corneal densitometry measured with Pentacam, expressed as percentage
    Time Frame
    1-2 hours after surgery
    Title
    Corneal densitometry
    Description
    Corneal densitometry measured with Pentacam, expressed as percentage
    Time Frame
    1 day after surgery
    Title
    Corneal densitometry
    Description
    Corneal densitometry measured with Pentacam, expressed as percentage
    Time Frame
    1 week after surgery
    Title
    Corneal densitometry
    Description
    Corneal densitometry measured with Pentacam, expressed as percentage
    Time Frame
    1 month after surgery
    Title
    Amount of phaco energy used
    Description
    Amount of phaco energy used, expressed as Cumulative Dissipated Energy (CDE, for Alcon Centurion) or as Equivalent Phaco Time (EPT, for Zeiss Quatera 700)
    Time Frame
    Surgery day
    Title
    Amount of balanced salt solution used
    Description
    Amount of balanced salt solution used, expressed in milliliters
    Time Frame
    Surgery day
    Title
    Total surgery time
    Description
    Total surgery time per eye
    Time Frame
    Surgery day
    Title
    Uncorrected Distance Visual Acuity
    Description
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    preoperative
    Title
    Uncorrected Distance Visual Acuity
    Description
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    1-2 hours after surgery
    Title
    Uncorrected Distance Visual Acuity
    Description
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    1 day after surgery
    Title
    Uncorrected Distance Visual Acuity
    Description
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    1 week after surgery
    Title
    Uncorrected Distance Visual Acuity
    Description
    Uncorrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    1 month after surgery
    Title
    Corrected Distance Visual Acuity
    Description
    Corrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    preoperative
    Title
    Corrected Distance Visual Acuity
    Description
    Corrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    1 day after surgery
    Title
    Corrected Distance Visual Acuity
    Description
    Corrected Distance Visual Acuity, expressed as logMAR
    Time Frame
    1 week after surgery
    Title
    Corneal pachymetry
    Description
    Corneal thickness measured with Pentacam, expressed as um
    Time Frame
    1 month after surgery
    Title
    Corneal pachymetry
    Description
    Corneal thickness measured with Pentacam, expressed as um
    Time Frame
    preoperative
    Title
    Corneal pachymetry
    Description
    Corneal thickness measured with Pentacam, expressed as um
    Time Frame
    1-2 hours after surgery
    Title
    Corneal pachymetry
    Description
    Corneal thickness measured with Pentacam, expressed as um
    Time Frame
    1 day after surgery
    Title
    Corneal pachymetry
    Description
    Corneal thickness measured with Pentacam, expressed as um
    Time Frame
    1 week after surgery
    Title
    Presence of corneal oedema
    Description
    Presence of corneal oedema with slit lamp biomicroscopy
    Time Frame
    preoperative
    Title
    Presence of corneal oedema
    Description
    Presence of corneal oedema with slit lamp biomicroscopy
    Time Frame
    1-2 hours after surgery
    Title
    Presence of corneal oedema
    Description
    Presence of corneal oedema with slit lamp biomicroscopy
    Time Frame
    1 day after surgery
    Title
    Presence of corneal oedema
    Description
    Presence of corneal oedema with slit lamp biomicroscopy
    Time Frame
    1 week after surgery
    Title
    Presence of corneal oedema
    Description
    Presence of corneal oedema with slit lamp biomicroscopy
    Time Frame
    1 month after surgery
    Title
    Catquest-9SF
    Description
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Time Frame
    preoperative
    Title
    Catquest-9SF
    Description
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Time Frame
    1-2 hours after surgery
    Title
    Catquest-9SF
    Description
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Time Frame
    1 day after surgery
    Title
    Catquest-9SF
    Description
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Time Frame
    1 week after surgery
    Title
    Catquest-9SF
    Description
    Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
    Time Frame
    1 month after surgery
    Title
    Patient-Perceived Satisfactory Improvement in Vision
    Description
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
    Time Frame
    1-2 hours after surgery
    Title
    Patient-Perceived Satisfactory Improvement in Vision
    Description
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
    Time Frame
    1 day after surgery
    Title
    Patient-Perceived Satisfactory Improvement in Vision
    Description
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
    Time Frame
    1 week after surgery
    Title
    Patient-Perceived Satisfactory Improvement in Vision
    Description
    Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
    Time Frame
    1 month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of cataract in both eyes, Having consented to and is planned to undergo cataract surgery in both eyes, Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes, A targeted refractive error of emmetropia, Corneal astigmatism of ≤1.5 D, Age of at least 18 years, Willing and able to participate in both preoperative and postoperative examinations, and Agreeing to sign the informed consent form. Exclusion Criteria: Insufficient understanding of the Dutch language to comply with study procedures, Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident, Subjects with a history of ocular surgery (e.g., corneal refractive surgery), Subjects with an increased risk of complicated cataract surgery: Lens subluxation or (phaco)iridodonesis, Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and History of ocular trauma, Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nic J. Reus, MD, PhD
    Phone
    +31765952239
    Email
    nreus@amphia.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nic J. Reus, MD, PhD
    Organizational Affiliation
    Amphia Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cataract Surgery Technique and Ocular Clarity

    We'll reach out to this number within 24 hrs