Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma
Primary Purpose
Glaucoma, Open-Angle
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brimonidine Tartrate
Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops
Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension
Travoprost and Timolol
Bimatoprost and Timolol
Latanoprost
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring choroidal thickness, multifocal electroretinography, optic nerve head, optical coherence tomography, primer open-angle glaucoma
Eligibility Criteria
Inclusion Criteria for the glaucoma group:
- the best corrected visual acuity (BCVA) of 0.6 and above
- Intraocular pressure being above 21 mmHg
- Detection of open-angle by gonioscopy
- Detection of glaucomatous optic disc pitting by fundus examination
- Visual field defect in perimetry (Carl Zeiss Meditec AG, Germany)
Exclusion Criteria for the glaucoma group:
- A secondary cause of glaucoma
- Angle-closure in gonioscopic examination
- Corneal opacity or cataract at the level that may affect imaging, vitreous pathology
- Intravitreal hemorrhage that may affect fundus appearance, retinal pathology
- Chorioretinopathy, optic neuropathy, optic disc pathology, spherical refractive error of 6D and above, cylindrical refraction error of 3D and above and systemic diseases which may affect ocular blood flow
Inclusion Criteria for the healthy group:
- The best corrected visual acuity (BCVA) of 0.8 and above
Exclusion Criteria for the healthy group:
- Presence of systemic disease that may affect choroid blood flow
- Ocular conditions that may affect test measurements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Primary open-angle glaucoma
Healthy
Arm Description
Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants.
Healthy volunteers who do not have systemic disease that may affect the choroidal thickness and have no ocular features that may affect test measurements.
Outcomes
Primary Outcome Measures
Macular choroidal thickness measure
Measuring macular choroidal thickness at baseline, at 1-month, at 3-month and at 6-month by using optical coherence tomography
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)
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]
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 amplitudes of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
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]
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 impulse times of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
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 impulse times of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
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 P1/N1 ratio of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4
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 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])
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])
Measuring neuroretinal rim area [mm2] at 1-month, at 3-month and at 6-month
Changes in the mean cup volume [mm3]
Measuring cup volume [mm3] at 1-month, at 3-month and at 6-month
Changes in the mean cup-to-disc ratios
Measuring cup-to-disc ratios at 1-month, at 3-month and at 6-month
Changes in the mean disc area [mm2]
Measuring disc area [mm2] at 1-month, at 3-month and at 6-month
Changes in the mean retinal nerve fiber layer thickness [micrometers]
Measuring retinal nerve fiber layer thicknesses [micrometers] at 1-month, at 3-month and at 6-month
Secondary Outcome Measures
Best-corrected visual acuity measure
Comparison of the mean best-corrected visual acuities at 1-month, at 3-month and at 6-month
Intraocular pressure measure
Measuring intraocular pressure at 1-month, at 3-month and at 6-month
Correlations between choroidal thickness and other parameters
Analyze correlations between changes of choroidal thicknesses and changes of other parameters during the study.
Full Information
NCT ID
NCT03966560
First Posted
May 16, 2019
Last Updated
May 24, 2019
Sponsor
Afyon Kocatepe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03966560
Brief Title
Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma
Official Title
Choroidal Thickness and Its Correlations With Ocular Parameters in Cases With Primary Open-angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Afyon Kocatepe University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
choroidal thickness, multifocal electroretinography, optic nerve head, optical coherence tomography, primer open-angle glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective controlled clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary open-angle glaucoma
Arm Type
Experimental
Arm Description
Participants over 40 years of age and diagnosed with primary open-angle glaucoma.
Medical treatment was initiated for the diagnosed participants.
Arm Title
Healthy
Arm Type
No Intervention
Arm Description
Healthy volunteers who do not have systemic disease that may affect the choroidal thickness and have no ocular features that may affect test measurements.
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate
Other Intervention Name(s)
Brimonidine Tartrate 0.15%
Intervention Description
Brimonidine tartrate 0.15% 1 eye drop, every day for 6-months
Intervention Type
Drug
Intervention Name(s)
Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops
Other Intervention Name(s)
Dorzolamide and timolol fixed combination
Intervention Description
Dorzolamide and timolol fixed combination 2 eye drops, every day for 6 months
Intervention Type
Drug
Intervention Name(s)
Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension
Other Intervention Name(s)
Brinzolamide and timolol fixed combination
Intervention Description
Brinzolamide and timolol fixed combination 2 eye drops, every day for 6 months
Intervention Type
Drug
Intervention Name(s)
Travoprost and Timolol
Other Intervention Name(s)
Travoprost 0.004%/timolol 0.5% fixed combination
Intervention Description
Travoprost and Timolol fixed combination 1 eye drop, every day for 6 months
Intervention Type
Drug
Intervention Name(s)
Bimatoprost and Timolol
Other Intervention Name(s)
Bimatoprost 0.03%/timolol 0.5% fixed combination
Intervention Description
Bimatoprost and Timolol fixed combination 1 eye drop, every day for 6 months
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Other Intervention Name(s)
Latanoprost 0.005%
Intervention Description
Latanoprost 0.005% 1 eye drop, every day for 6 months
Primary Outcome Measure Information:
Title
Macular choroidal thickness measure
Description
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
Title
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)
Description
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
Title
Changes in amplitudes of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Description
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
Title
Changes in amplitudes of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Description
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
Title
Changes in amplitudes of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [nv/deg2]
Description
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
Title
Changes in impulse times of N1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
Description
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
Title
Changes in impulse times of P1 wave in Ring-1, Ring-2, Ring-3 and Ring-4 [ms]
Description
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
Title
Changes in P1/N1 ratio of N2 wave in Ring-1, Ring-2, Ring-3 and Ring-4
Description
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
Title
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])
Description
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
Title
Changes in the mean neuroretinal rim area [mm2])
Description
Measuring neuroretinal rim area [mm2] at 1-month, at 3-month and at 6-month
Time Frame
Baseline, 1-month, 3-month, 6-month
Title
Changes in the mean cup volume [mm3]
Description
Measuring cup volume [mm3] at 1-month, at 3-month and at 6-month
Time Frame
Baseline, 1-month, 3-month, 6-month
Title
Changes in the mean cup-to-disc ratios
Description
Measuring cup-to-disc ratios at 1-month, at 3-month and at 6-month
Time Frame
Baseline, 1-month, 3-month, 6-month
Title
Changes in the mean disc area [mm2]
Description
Measuring disc area [mm2] at 1-month, at 3-month and at 6-month
Time Frame
Baseline, 1-month, 3-month, 6-month
Title
Changes in the mean retinal nerve fiber layer thickness [micrometers]
Description
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
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity measure
Description
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
Title
Intraocular pressure measure
Description
Measuring intraocular pressure at 1-month, at 3-month and at 6-month
Time Frame
Baseline, 1-month, 3-month, 6-month
Title
Correlations between choroidal thickness and other parameters
Description
Analyze correlations between changes of choroidal thicknesses and changes of other parameters during the study.
Time Frame
Baseline, 6-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for the glaucoma group:
the best corrected visual acuity (BCVA) of 0.6 and above
Intraocular pressure being above 21 mmHg
Detection of open-angle by gonioscopy
Detection of glaucomatous optic disc pitting by fundus examination
Visual field defect in perimetry (Carl Zeiss Meditec AG, Germany)
Exclusion Criteria for the glaucoma group:
A secondary cause of glaucoma
Angle-closure in gonioscopic examination
Corneal opacity or cataract at the level that may affect imaging, vitreous pathology
Intravitreal hemorrhage that may affect fundus appearance, retinal pathology
Chorioretinopathy, optic neuropathy, optic disc pathology, spherical refractive error of 6D and above, cylindrical refraction error of 3D and above and systemic diseases which may affect ocular blood flow
Inclusion Criteria for the healthy group:
The best corrected visual acuity (BCVA) of 0.8 and above
Exclusion Criteria for the healthy group:
Presence of systemic disease that may affect choroid blood flow
Ocular conditions that may affect test measurements
12. IPD Sharing Statement
Learn more about this trial
Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma
We'll reach out to this number within 24 hrs