Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.
Investigational Device: 0.3-mL intraocular gas (C3F8) injection Objectives Primary 1. To compare the proportion of eyes with central VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole. Secondary 2. To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection. Study Design: Multi-center, randomized clinical trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.
No intervention; sham injection only
Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy
Time frame: at 24 Weeks
Number of Eyes With Rescue Treatment Before the 24-week Visit
Time frame: up to 24 weeks
Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit
scheduled rescue vitrectomy must be completed within the subsequent 12 weeks.
Time frame: through 24 Weeks
Number of Eyes With Central Vitreomacular Traction Status
Time frame: up to 24 weeks
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: Baseline to 24 weeks
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