Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma
- Conditions
- Glaucoma, Open-Angle
- Interventions
- Drug: Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension
- Registration Number
- NCT03966560
- Lead Sponsor
- Afyon Kocatepe University Hospital
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary open-angle glaucoma Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants. Primary open-angle glaucoma Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants. Primary open-angle glaucoma Travoprost and Timolol Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants. Primary open-angle glaucoma Brimonidine Tartrate Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants. Primary open-angle glaucoma Latanoprost Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants. Primary open-angle glaucoma Bimatoprost and Timolol Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants.
- Primary Outcome Measures
Name Time Method Changes in the mean cup volume [mm3] Baseline, 1-month, 3-month, 6-month Measuring cup volume \[mm3\] at 1-month, at 3-month and at 6-month
Changes in impulse times of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms] 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
Changes in 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) 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
Changes in amplitudes of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2] 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
Changes in the mean cup-to-disc ratios Baseline, 1-month, 3-month, 6-month Measuring cup-to-disc ratios at 1-month, at 3-month and at 6-month
Changes in the mean disc area [mm2] Baseline, 1-month, 3-month, 6-month Measuring disc area \[mm2\] at 1-month, at 3-month and at 6-month
Macular choroidal thickness measure 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
Changes in impulse times of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms] 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
Changes in P1/N1 ratio of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4 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
Changes in the mean retinal nerve fiber layer thickness [micrometers] Baseline, 1-month, 3-month, 6-month Measuring retinal nerve fiber layer thicknesses \[micrometers\] at 1-month, at 3-month and at 6-month
Changes in amplitudes of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2] 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
Changes in amplitudes of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2] 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
Changes in the mean 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]) 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
Changes in the mean neuroretinal rim area [mm2]) Baseline, 1-month, 3-month, 6-month Measuring neuroretinal rim area \[mm2\] at 1-month, at 3-month and at 6-month
- Secondary Outcome Measures
Name Time Method Best-corrected visual acuity measure 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
Intraocular pressure measure Baseline, 1-month, 3-month, 6-month Measuring intraocular pressure at 1-month, at 3-month and at 6-month
Correlations between choroidal thickness and other parameters Baseline, 6-month Analyze correlations between changes of choroidal thicknesses and changes of other parameters during the study.