N/A N=61

Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure?

Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT02600403 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Visual Field Mean Deviation — -8.7; -13.3; -13.2; -8.3 dB (decibels)

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Optical Coherence Tomography (OCT) (Diagnostic_test); Visual evoked potential (VEP) (Diagnostic_test); Humphrey Visual Field (HVF) (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wills Eye
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Field Mean Deviation	-8.7; -13.3; -13.2; -8.3; -14.1; -8.6	—
PRIMARY Retinal Nerve Fiber Layer (RNFL) Thickness Measurement	75.5; 74.3; 70.4; 74.9; 76; 69.4	—
PRIMARY Average Cup to Disc Ratio	0.71; 0.76; 0.76; 0.69; 0.74; 0.77	—
PRIMARY Visual Evoked Potential Amplitudes	12.7; 10.7; 12.1; 12.1; 9.5; 12.5	—
PRIMARY Visual Evoked Potential Latency	126.1; 117.0; 114.1; 110.1; 125.7; 139.8	—
PRIMARY Visual Field	4.9; 6.3; 6.8; 5.0; 4.0; 5.8	—

Summary

The aim of this study was to evaluate structural and functional improvement after lowering intraocular pressure (IOP) in patients with glaucoma using Spectral Domain Optical Coherence Tomography (SD-OCT), Visual Field (VF) testing, and Visual Evoked Potential (VEP).

Eligibility Criteria

Inclusion Criteria

All patients with glaucoma (primary open-angle glaucoma, angle recession glaucoma, exfoliation syndrome glaucoma, pigmentary glaucoma and chronic angle closure glaucoma) in whom a pressure-lowering intervention was conducted

Exclusion Criteria

Inability to obtain reliable field or optical coherence tomography pre-intervention
Visual acuity less than 20/40,
Age 90 years,
Other cause for visual field loss not glaucoma, that is, visual field loss due to cataract optic neuropathies, retinal disease
Spherical equivalent refractive error > +5.00 Diopters and > 3.00 Diopters cylinder
Concomitant cataract and glaucoma surgery

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Data sourced from ClinicalTrials.gov (NCT02600403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.