NCT02897583

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

June 16, 2016

Last Update Submit

September 12, 2016

Conditions

Weiss RingFloatersPosterior Vitreous Detachment

Outcome Measures

Primary Outcomes (1)

  • 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?"

    6 Months

Secondary Outcomes (5)

  • Best Corrected Visual Acuity

    6 Months

  • VFQ-25 Near Activities

    6 Months

  • VFQ-25 Distance Activities

    6 Months

  • Qualitative changes on infrared and color photography

    6 Months

  • Incidence and severity of ocular and systemic adverse events

    6 Months

Study Arms (2)

YAG vitreolysis

EXPERIMENTAL

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 YAG vitreolysis

SHAM COMPARATOR

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

Interventions

YAG vitreolysisPROCEDURE
Sham YAG vitreolysisYAG vitreolysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28727887DERIVED

MeSH Terms

Conditions

vitreous floatersVitreous Detachment

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Chirag P Shah, MD, MPH

    Attending Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

September 13, 2016

Study Start

February 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 13, 2016

Record last verified: 2016-09