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YAG Vitreolysis for Floaters

Primary Purpose

Weiss Ring, Floaters, Posterior Vitreous Detachment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
YAG vitreolysis
Sponsored by
Ophthalmic Consultants of Boston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weiss Ring

Eligibility Criteria

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

Inclusion Criteria:

  1. Symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months
  2. Documented posterior vitreous detachment on clinical examination, OCT, and B scan
  3. Self-rating of visual disturbance by the floaters must be at least 4 on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms.
  4. Symptomatic Weiss ring (PVD) must be at least 3 mm away from the retina and 5 mm from the posterior lens capsule of the crystalline lens, as measured on B-scan. For pseudophakic patients, there is no minimum required distance from the intraocular lens.
  5. Able to position for the YAG laser procedure.
  6. Accept the risks of YAG laser including but not limited to retinal detachment, intraocular hemorrhage, retinal damage, cataract formation, optic nerve damage, inflammation, and irreversible loss of vision.
  7. Willing and able to comply with clinic visits and study-related procedures
  8. If the patient has two symptomatic eyes, only one eye can be randomized and included in the study.
  9. Provide signed informed consent

Exclusion Criteria:

  1. Snellen best corrected visual acuity worse than 20/50 in the fellow eye
  2. History of retinal tear, retinal detachment, or uveitis in the study eye
  3. History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye
  4. History of glaucoma or high intraocular pressure defined as having a history of glaucoma surgery or currently taking two or more topical glaucoma medications in the study eye

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    YAG vitreolysis

    Sham YAG vitreolysis

    Arm Description

    A Karickoff lens with goniosol will be used to perform the YAG vitreolysis. The number of shots will be determined at the discretion of the treating physician. A focus offset may be used at investigator discretion. Single shot mode will be used. The maximum energy per pulse will be 7 mJ. The endpoint of treatment is the vaporization of the Weiss ring into gas, as well as the disruption of it into smaller fragments as well as any other vitreous opacities deemed visually significant by the treating physician. Only one treatment session will be performed.

    Sham laser treatment will be applied under the same procedure used for laser treatment but by turning the laser power down to 0.3 mJ and using a separate lens covered by a filter that absorbs the power, so no laser enters the eye.

    Outcomes

    Primary Outcome Measures

    Subjective improvement in floater symptoms
    Questionnaire which asks: "Please rate your visual disturbance by the floaters on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms," "Please quantify your post-operative improvement as a percentage," and "How would you describe your floaters today compared to right before the laser procedure?"

    Secondary Outcome Measures

    Best Corrected Visual Acuity
    Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months
    VFQ-25 Near Activities
    Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale
    VFQ-25 Distance Activities
    Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale
    Qualitative changes on infrared and color photography
    Qualitative changes on infrared and color photography
    Incidence and severity of ocular and systemic adverse events
    Incidence and severity of ocular and systemic adverse events

    Full Information

    First Posted
    June 16, 2016
    Last Updated
    September 12, 2016
    Sponsor
    Ophthalmic Consultants of Boston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02897583
    Brief Title
    YAG Vitreolysis for Floaters
    Official Title
    A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of YAG Vitreolysis Versus Sham for Symptomatic Weiss Ring Due to Posterior Vitreous Detachment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ophthalmic Consultants of Boston

    4. Oversight

    5. Study Description

    Brief Summary
    This is a single-center, prospective randomized controlled trial evaluating the safety and efficacy of YAG vitreolysis versus sham for symptomatic Weiss ring due to posterior vitreous detachment.
    Detailed Description
    52 subjects will be enrolled in the trial and randomized in a 2:1 ratio to receive either YAG laser vitreolysis or sham laser for symptomatic Weiss ring due to posterior vitreous detachment. Subjects will follow up at one week, one month, three months, and six months after the procedure. Assessments will include a questionnaire regarding duration of floater symptoms prior to presentation, severity of floater symptoms, number of floaters, and activity most inconvenienced by presence of floaters; Medical, ocular history and demographics collected; ETDRS and Snellen visual acuity; Optos color photography; Heidelberg Spectralis Optical Coherence Tomography (OCT) and infrared photo; B scan ultrasound of Weiss ring with caliper measurement of nearest distance between Weiss ring and retina, Weiss ring and posterior lens capsule (only in phakic eyes); Slit lamp and indirect ophthalmoscopy with scleral depression of study eye; Applanation tonometry; Visual Functioning Questionnaire-25 (VFQ 25). Qualitative change in Optos photography will evaluated by a masked physician.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weiss Ring, Floaters, Posterior Vitreous Detachment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    YAG vitreolysis
    Arm Type
    Experimental
    Arm Description
    A Karickoff lens with goniosol will be used to perform the YAG vitreolysis. The number of shots will be determined at the discretion of the treating physician. A focus offset may be used at investigator discretion. Single shot mode will be used. The maximum energy per pulse will be 7 mJ. The endpoint of treatment is the vaporization of the Weiss ring into gas, as well as the disruption of it into smaller fragments as well as any other vitreous opacities deemed visually significant by the treating physician. Only one treatment session will be performed.
    Arm Title
    Sham YAG vitreolysis
    Arm Type
    Sham Comparator
    Arm Description
    Sham laser treatment will be applied under the same procedure used for laser treatment but by turning the laser power down to 0.3 mJ and using a separate lens covered by a filter that absorbs the power, so no laser enters the eye.
    Intervention Type
    Procedure
    Intervention Name(s)
    YAG vitreolysis
    Primary Outcome Measure Information:
    Title
    Subjective improvement in floater symptoms
    Description
    Questionnaire which asks: "Please rate your visual disturbance by the floaters on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms," "Please quantify your post-operative improvement as a percentage," and "How would you describe your floaters today compared to right before the laser procedure?"
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    Best Corrected Visual Acuity
    Description
    Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months
    Time Frame
    6 Months
    Title
    VFQ-25 Near Activities
    Description
    Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale
    Time Frame
    6 Months
    Title
    VFQ-25 Distance Activities
    Description
    Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale
    Time Frame
    6 Months
    Title
    Qualitative changes on infrared and color photography
    Description
    Qualitative changes on infrared and color photography
    Time Frame
    6 Months
    Title
    Incidence and severity of ocular and systemic adverse events
    Description
    Incidence and severity of ocular and systemic adverse events
    Time Frame
    6 Months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months Documented posterior vitreous detachment on clinical examination, OCT, and B scan Self-rating of visual disturbance by the floaters must be at least 4 on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms. Symptomatic Weiss ring (PVD) must be at least 3 mm away from the retina and 5 mm from the posterior lens capsule of the crystalline lens, as measured on B-scan. For pseudophakic patients, there is no minimum required distance from the intraocular lens. Able to position for the YAG laser procedure. Accept the risks of YAG laser including but not limited to retinal detachment, intraocular hemorrhage, retinal damage, cataract formation, optic nerve damage, inflammation, and irreversible loss of vision. Willing and able to comply with clinic visits and study-related procedures If the patient has two symptomatic eyes, only one eye can be randomized and included in the study. Provide signed informed consent Exclusion Criteria: Snellen best corrected visual acuity worse than 20/50 in the fellow eye History of retinal tear, retinal detachment, or uveitis in the study eye History of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye History of glaucoma or high intraocular pressure defined as having a history of glaucoma surgery or currently taking two or more topical glaucoma medications in the study eye
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chirag P Shah, MD, MPH
    Organizational Affiliation
    Attending Physician
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28727887
    Citation
    Shah CP, Heier JS. YAG Laser Vitreolysis vs Sham YAG Vitreolysis for Symptomatic Vitreous Floaters: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Sep 1;135(9):918-923. doi: 10.1001/jamaophthalmol.2017.2388.
    Results Reference
    derived

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    YAG Vitreolysis for Floaters

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