Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.
The objective of this trial is to obtain estimates of the proportion of eyes with MH closure of the inner retinal layers for eyes with VMT and full-thickness MHs treated with PVL. Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary. Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Intraocular gas (C3F8) injection
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy
Time frame: at 8 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 8 weeks
E-ETDRS Visual Acuity Letter Score
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: 8 weeks
Number of Eyes With Rescue Treatment Before the 8-week Visit
Time frame: up to 8 Weeks
Macular Hole Closure Without Rescue Vitrectomy
Time frame: 8 Weeks
Macular Hole Closure With Rescue Vitrectomy
Time frame: 8 weeks
No Macular Hole Closure and no Rescue Vitrectomy
Time frame: 8 weeks
No Macular Hole Closure Despite Rescue Vitrectomy
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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