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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
Afyon Kocatepe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 16, 2019
    Last Updated
    May 24, 2019
    Sponsor
    Afyon Kocatepe University Hospital
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    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

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