YAG Vitreolysis for Floaters

Posterior Vitreous Detachment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897583
• Other study ID #: YAG-001
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: September 12, 2016
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Ophthalmic Consultants of Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Floaters
• Posterior Vitreous Detachment
• Vitreous Detachment
• Weiss Ring

Intervention

Procedure:
• YAG vitreolysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Boston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Best Corrected Visual Acuity	Mean change in visual acuity from Baseline as measured by ETDRS vision testing at 6 months	6 Months	No
Secondary	VFQ-25 Near Activities	Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale	6 Months	No
Secondary	VFQ-25 Distance Activities	Mean change in baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) distance activities subscale	6 Months	No
Secondary	Qualitative changes on infrared and color photography	Qualitative changes on infrared and color photography	6 Months	No
Secondary	Incidence and severity of ocular and systemic adverse events	Incidence and severity of ocular and systemic adverse events	6 Months	Yes