search
Back to results

Cataract Surgery: Femto LDV Z8 Versus Conventional (COMFORT)

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Femto LDV Z8
Manual capsulorhexis&lens fragmentation
Sponsored by
Ziemer Ophthalmic Systems AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens Implantation
  • Able to co-operate with the docking system for the femtosecond laser
  • Clear corneal media
  • 50 years of age or older
  • Willing and able to return for scheduled follow-up examinations

Exclusion Criteria:

  • Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
  • Maximum K-value that exceeds 58D
  • Minimal K-value of less than 37D
  • Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
  • Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
  • Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
  • Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
  • Known sensitivity to planned concomitant medications
  • History of lens or zonular instability
  • Keratoconus or keratectasia
  • Immune compromised or diagnosis of connective tissue disease, clinically sign. atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study PI.
  • Anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured from the corneal endothelium.
  • Extensive corneal scarring
  • Developmental disability or cognitive impairment (would preclude adequate comprehension of the Informed Consent (IC) form and/or the ability to record the study measurements)
  • Concurrent participation in another ophthalmological clinical study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Femto LDV Z8

    Manual capsulorhexis&lens fragmentation

    Arm Description

    Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification

    The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification

    Outcomes

    Primary Outcome Measures

    Effective Phaco Time (EPT)
    Effective Phacoemulsification Time (EPT): EPT for eyes receiving Intervention A being statistically same or lower than EPT for eyes receiving Intervention B at p<0.05 will be considered positive for superior efficacy of application of FEMTO LDV Z8 over the manual procedure Effective Phaco Time is a unit. It is commonly understood in the area of cataract surgery to be the standard way to describe phaco energy during a procedure over different manufactured phaco devices. Effective phaco time is the total phaco time at 100 percent phaco power. It can be less than the total foot-pedal time. Less EPT indicates proportionately less energy delivered to the eye thereby reducing the side effects of phaco power.

    Secondary Outcome Measures

    Ease of Phacoemulsification
    Ease of phacoemulsification was performed as a subjective observation by the surgeon. Four classifications were possible: easy - phacoemulsification was fast and uncomplicated; 'slight resistance' - phacoemulsification encountered some difficulty; 'resistance noted' - phacoemulsification was somewhat complex; 'difficult' - phacoemulsification was difficult and complex to complete.
    Number of Participants With Complete Treatment Pattern
    Completeness of capsulotomy is a subjective metric given by the surgeon. Measurements were scaled into the following four categories: 1: complete treatment pattern; 2: micro-adhesion; 3: incomplete treatment pattern; 4: complete pattern but not continuous. "Complete treatment pattern" is considered the best result, "micro adhesion" indicates a minor but manageable problem, "incomplete treatment pattern" indicates a treatable, but more complex suboptimal outcome and "complete treatment but discontinuous pattern" indicates the treatable but suboptimal outcome.

    Full Information

    First Posted
    January 16, 2015
    Last Updated
    September 30, 2019
    Sponsor
    Ziemer Ophthalmic Systems AG
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02351271
    Brief Title
    Cataract Surgery: Femto LDV Z8 Versus Conventional
    Acronym
    COMFORT
    Official Title
    A Single Centre Randomized Eye Study to Compare the Performance and Safety of Femtosecond Laser-assisted Cataract Procedures With Conventional Ultrasound-assisted Cataract Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    December 28, 2016 (Actual)
    Study Completion Date
    February 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ziemer Ophthalmic Systems AG

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract surgery.
    Detailed Description
    Cataract Surgery according to conventional procedure, with the exception of two steps (Capsulotomy and Lens Fragmentation) which are performed with a Femtosecond Laser in the study group. Used equipment for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment (group A) Cataract surgery will be performed conventionally, this means the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification. (group B)

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Femto LDV Z8
    Arm Type
    Experimental
    Arm Description
    Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
    Arm Title
    Manual capsulorhexis&lens fragmentation
    Arm Type
    Active Comparator
    Arm Description
    The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification
    Intervention Type
    Device
    Intervention Name(s)
    Femto LDV Z8
    Other Intervention Name(s)
    Treatment A
    Intervention Description
    Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
    Intervention Type
    Device
    Intervention Name(s)
    Manual capsulorhexis&lens fragmentation
    Other Intervention Name(s)
    Treatment B
    Intervention Description
    Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device
    Primary Outcome Measure Information:
    Title
    Effective Phaco Time (EPT)
    Description
    Effective Phacoemulsification Time (EPT): EPT for eyes receiving Intervention A being statistically same or lower than EPT for eyes receiving Intervention B at p<0.05 will be considered positive for superior efficacy of application of FEMTO LDV Z8 over the manual procedure Effective Phaco Time is a unit. It is commonly understood in the area of cataract surgery to be the standard way to describe phaco energy during a procedure over different manufactured phaco devices. Effective phaco time is the total phaco time at 100 percent phaco power. It can be less than the total foot-pedal time. Less EPT indicates proportionately less energy delivered to the eye thereby reducing the side effects of phaco power.
    Time Frame
    day of surgery
    Secondary Outcome Measure Information:
    Title
    Ease of Phacoemulsification
    Description
    Ease of phacoemulsification was performed as a subjective observation by the surgeon. Four classifications were possible: easy - phacoemulsification was fast and uncomplicated; 'slight resistance' - phacoemulsification encountered some difficulty; 'resistance noted' - phacoemulsification was somewhat complex; 'difficult' - phacoemulsification was difficult and complex to complete.
    Time Frame
    during surgery
    Title
    Number of Participants With Complete Treatment Pattern
    Description
    Completeness of capsulotomy is a subjective metric given by the surgeon. Measurements were scaled into the following four categories: 1: complete treatment pattern; 2: micro-adhesion; 3: incomplete treatment pattern; 4: complete pattern but not continuous. "Complete treatment pattern" is considered the best result, "micro adhesion" indicates a minor but manageable problem, "incomplete treatment pattern" indicates a treatable, but more complex suboptimal outcome and "complete treatment but discontinuous pattern" indicates the treatable but suboptimal outcome.
    Time Frame
    during surgery
    Other Pre-specified Outcome Measures:
    Title
    Number of Participants With Reported Complications
    Description
    Safety will be assessed by evaluating observed and/or reported device and non-device related Adverse Events and/or Adverse Device Effects between treatment intervention groups A and B. No serious adverse events were reported. One AE in the femto group and two in the manual group were reported.
    Time Frame
    during follow-up after 1 and 12 days, 4, 8 and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens Implantation Able to co-operate with the docking system for the femtosecond laser Clear corneal media 50 years of age or older Willing and able to return for scheduled follow-up examinations Exclusion Criteria: Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea Maximum K-value that exceeds 58D Minimal K-value of less than 37D Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye Known sensitivity to planned concomitant medications History of lens or zonular instability Keratoconus or keratectasia Immune compromised or diagnosis of connective tissue disease, clinically sign. atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study PI. Anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured from the corneal endothelium. Extensive corneal scarring Developmental disability or cognitive impairment (would preclude adequate comprehension of the Informed Consent (IC) form and/or the ability to record the study measurements) Concurrent participation in another ophthalmological clinical study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bojan Pajic, MD, PhD
    Organizational Affiliation
    Augenzentrum ORASIS AG
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Cataract Surgery: Femto LDV Z8 Versus Conventional

    We'll reach out to this number within 24 hrs