Brimonidine Tartrate
DrugBrimonidine tartrate 0.15% 1 eye drop, every day for 6-months
Other names: Brimonidine Tartrate 0.15%
NCT Number: NCT03966560
Glaucoma is one of the leading causes of blindness worldwide that is a chronic public health problem. Unfortunately, glaucoma can be diagnosed when the disease reaches a certain level in today's conditions. The aim of this study was to investigate the diagnostic methods that can diagnose glaucoma before it reaches the advanced level and to identify pathophysiological processes. In this study, choroidal thickness was investigated in primary open-angle glaucoma cases and its correlations with OCT and multifocal ERG parameters were evaluated.
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Notify Me40 year and older
All sexes
Interventional
Phase 4
In this study, patients with primary open-angle glaucoma who have recently received a new diagnosis with healthy volunteers with age-matched groups were enrolled. All data from 49 glaucoma patients and 47 healthy volunteers were recorded and the study was completed. The study was carried out at the Afyon Kocatepe University Ophthalmology Department between January 2014 and April 2015. Routine ophthalmologic examinations of all participants were performed. Medical treatment was initiated on patients diagnosed with primary open-angle glaucoma. Intraocular pressures and visual acuities of all participants were recorded at baseline, at 1-month, at 3-month, and at 6-month. All participants underwent tests of multifocal electroretinography and the measurements of optic nerve head optical coherence tomography parameters and the choroidal thickness, at the same follow-ups. Visual acuities were measured by using the Snellen chart as the best corrected visual acuity. Intraocular pressures were measured by using applanation tonometry. Choroid thicknesses were also measured and recorded using EDI-OCT mode of optical coherence tomography device (Cirrus HD 4000, Carl Zeiss Meditec AG, Germany). Choroidal thicknesses were measured in three regions: fovea, 3mm nasal and temporal distances of the fovea. The mean of these three measurements was recorded as macular choroidal thickness. The same technician performed all multifocal electroretinography tests of the participants (Metrovision Monpack 3, Metrovision, France). Multifocal electroretinography tests were carried out from a distance of 33 cm using ERG-jet electrode, ground electrode, and a reference electrode. Electrical potential responses from 103 retina regions were recorded. Results were compared statistically and correlations were analyzed (SPSS 20.0, SPSS Inc. IL, USA).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for the glaucoma group:
Exclusion criteria
for the glaucoma group:
Inclusion criteria
for the healthy group:
Exclusion criteria
for the healthy group:
Brimonidine tartrate 0.15% 1 eye drop, every day for 6-months
Other names: Brimonidine Tartrate 0.15%
Dorzolamide and timolol fixed combination 2 eye drops, every day for 6 months
Other names: Dorzolamide and timolol fixed combination
Brinzolamide and timolol fixed combination 2 eye drops, every day for 6 months
Other names: Brinzolamide and timolol fixed combination
Travoprost and Timolol fixed combination 1 eye drop, every day for 6 months
Other names: Travoprost 0.004%/timolol 0.5% fixed combination
Bimatoprost and Timolol fixed combination 1 eye drop, every day for 6 months
Other names: Bimatoprost 0.03%/timolol 0.5% fixed combination
Latanoprost 0.005% 1 eye drop, every day for 6 months
Other names: Latanoprost 0.005%
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring macular choroidal thickness at baseline, at 1-month, at 3-month and at 6-month by using optical coherence tomography
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean multifocal electroretinography parameters (Amplitudes [nv/deg2] and impulse times [ms] of N1, N2 and P1 waves in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean amplitudes of N1 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean amplitudes of N2 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean amplitudes of P1 wave [nv/deg2] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean impulse times of N1 wave [ms] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean impulse times of P1 wave [ms] in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean P1/N1 ratios of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4) at baseline, at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring optic nerve head optical coherence tomography parameters (Retinal nerve fiber layer thickness [micrometers], disc area [mm2], cup-to-disc ratios, cup volume [mm3], neuroretinal rim area [mm2]) at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring neuroretinal rim area [mm2] at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring cup volume [mm3] at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring cup-to-disc ratios at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring disc area [mm2] at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring retinal nerve fiber layer thicknesses [micrometers] at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Comparison of the mean best-corrected visual acuities at 1-month, at 3-month and at 6-month
Time frame: Baseline, 1-month, 3-month, 6-month
Measuring intraocular pressure at 1-month, at 3-month and at 6-month
Time frame: Baseline, 6-month
Analyze correlations between changes of choroidal thicknesses and changes of other parameters during the study.
Afyon Kocatepe University Hospital
Other
Choroidal Thickness and Its Correlations With Ocular Parameters in Cases With Primary Open-angle Glaucoma
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