YAG Vitreolysis for Floaters

NCT ID: NCT02897583

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-08-31

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.

Conditions

Weiss Ring; Floaters; Posterior Vitreous Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

YAG vitreolysis

Intervention Type: PROCEDURE

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.

Group Type: EXPERIMENTAL

YAG vitreolysis

Intervention Type: PROCEDURE

Interventions

YAG vitreolysis

Intervention Type: PROCEDURE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ophthalmic Consultants of Boston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chirag P Shah, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Attending Physician

References

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.

Reference Type: DERIVED

PMID: 28727887 (View on PubMed)

Other Identifiers

YAG-001

Identifier Type: -

Identifier Source: org_study_id