N/A
Completed N=61
Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure?
Source: ClinicalTrials.gov NCT02600403 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Visual Field Mean Deviation — -8.7; -13.3; -13.2; -8.3 dB (decibels)
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).
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 | — |
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
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. Informational only — not medical advice.