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YAG Vitreolysis for Floaters

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ClinicalTrials.gov Identifier: NCT02897583
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Ophthalmic Consultants of Boston

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.

Condition or disease Intervention/treatment Phase
Weiss Ring Floaters Posterior Vitreous Detachment Procedure: YAG vitreolysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : February 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: YAG vitreolysis
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.
Procedure: YAG vitreolysis
Sham Comparator: Sham YAG vitreolysis
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.
Procedure: YAG vitreolysis



Primary Outcome Measures :
  1. Subjective improvement in floater symptoms [ Time Frame: 6 Months ]
    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 :
  1. Best Corrected Visual Acuity [ Time Frame: 6 Months ]
    Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months

  2. VFQ-25 Near Activities [ Time Frame: 6 Months ]
    Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale

  3. VFQ-25 Distance Activities [ Time Frame: 6 Months ]
    Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale

  4. Qualitative changes on infrared and color photography [ Time Frame: 6 Months ]
    Qualitative changes on infrared and color photography

  5. Incidence and severity of ocular and systemic adverse events [ Time Frame: 6 Months ]
    Incidence and severity of ocular and systemic adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897583


Sponsors and Collaborators
Ophthalmic Consultants of Boston
Investigators
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Principal Investigator: Chirag P Shah, MD, MPH Attending Physician

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier: NCT02897583     History of Changes
Other Study ID Numbers: YAG-001
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Vitreous Detachment
Eye Diseases