Intravitreal Gas for Vitreomacular Adhesion

Withdrawn before enrolling · Not applicable

Conditions studied: Vitreomacular Adhesion

In brief

Vitreomacular adhesion causes symptoms of blurry vision, distortion, and double vision. It is due to an abnormal separation of the vitreous gel from the surface of the retina and macula. The current, gold-standard treatment for this condition involves surgery performed in the operating room that involves risk such as bleeding, infection, cataract, and retinal detachment. It has been previously shown that a less invasive intravitreal injection of a gas bubble performed in the office may also treat vitreomacular adhesion with less risk than surgery. The purpose of this study is to determine the effect of an office-based injection of an intravitreal gas bubble as a treatment for symptomatic vitreomacular adhesion.

Key facts

Study ID

NCT02001701

Run by

Northern California Retina Vitreous Associates

People needed

0

Starts

2013-11-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Able to provide written informed consent
• Patients with Symptomatic Vitreomacular Adhesion (sVMA) as defined by Clinical and SD-OCT findings:
• Clinical Findings:
• Symptoms: blurred vision, double vision, metamorphopsia, micropsia
• Snellen Visual Acuity: < 20/25 in study eye
• SD-OCT (Cirrus, Car Zeiss Meditec, Dublin, CA) Findings:
• Visible vitreous attachment within a 1,500 um radius of the foveal center causing antero-posterior vitreofoveal traction with associated microstructural retinal changes
• See Figure 1 (Image "E") for representative candidates for inclusion.
• Observation period of 1 month prior to intervention allowing for spontaneous resolution

You may not qualify if…

• Figure 1 (Images "A", "B", "C", "D", "F", "H", "I")
• Any Macular Hole
• Epiretinal Membrane
• History of Diabetic Retinopathy (non-proliferative, proliferative, and/or diabetic macular edema)
• Macular Degeneration
• Retinal vascular occlusion
• Aphakia
• High myopia (> -8 diopters)
• Uncontrolled glaucoma
• Vitreous Opacification
• Retinal tear or retinal detachment
• Vitrectomy surgery
• Macular laser
• Figure 1: Refer to the following article:
• Stalmans P, Duker JS, Kaiser PK, et al. OCT-Based Interpretation of the Vitreomacular Interface and Indications for Pharmacologic Vitreolysis. Retina; 2013: Epub ahead of print

Where it is running

• Northern California Retina Vitreous Associates — Mountain View, California, United States

Full record on ClinicalTrials.gov

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