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Shriji Patel, Rohan Shah, Joshua Noren Carlson, Jeffrey Kammer, Rachel W Kuchtey, Karen M Joos, Edward F Cherney, Stephen J Kim; Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) Study 24-Month Findings. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4329.
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© ARVO (1962-2015); The Authors (2016-present)
To report 2-year outcomes of the Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE) study.
The study is a prospective, controlled, observational study. The PROVE study was approved by the Vanderbilt University IRB. Eighty eyes of 40 participants undergoing pars plana vitrectomy for macular hole (MH), epiretinal membrane (ERM), or vitreous opacities (VO) were included. Enrolled participants underwent baseline evaluation of the study (surgical) and fellow (control) eyes by a masked fellowship-trained glaucoma specialist; evaluation included intraocular pressure (IOP), central corneal thickness, gonioscopy, and cup-to-disc ratio measurement. Baseline testing included bilateral color fundus and optic disc photography, fundus autofluorescence, automated perimetry, and optical coherence tomography (OCT) of the macula and optic nerve. Evaluations were repeated at 3 months, 1 year, and 2 years after surgery. The primary outcome measure was changes in peripapillary retinal nerve fiber layer (pRNFL) thickness. Secondary outcomes included changes in macular thickness and IOP. Stastistal analysis was performed using Student’s t-test and the Fisher exact test. The study is registered at clinicaltrials.gov (identifier NCT01162356).
Thirty-four patients completed 2-year follow-up. Mean logMAR visual acuity (VA) at baseline (0.394+/-0.37) improved significantly in study eyes (0.140+/-0.20, p<0.0001) but remained worse than fellow eyes (0.020+/-0.04, p<0.001). In study eyes, inferior pRNFL thickness decreased from 117+/-17 μm at baseline to 112+/-18 μm at two years (p<0.05). Temporal pRNL thickness decreased from 74.5+/-21 μm at baseline to 66.3+/-15 μm at two years (p<0.0001). Central subfield thickness (CST) decreased significantly in surgical eyes from baseline (p<0.0001) but did not improve to the level of the fellow eyes. There was no significant difference in IOP in surgical eyes. However, subgroup analysis demonstrated mean IOP at 2 years (16.5+/-3.2 mmHg) was significantly elevated in surgical eyes that were pseudophakic at baseline (14.4+/-2.9 mmHg, p<0.0001).
Two years after vitrectomy, VA and CST improved significantly from baseline in study eyes, however not to the level of fellow eyes. There was continued inferior and temporal pRNFL thinning in study eyes at two years. Pseudophakic eyes demonstrated a significant increase in IOP when compared to baseline.
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