Choroidal Thickness and Its Correlations With Ocular Parameters in Primary Open-angle Glaucoma

Choroidal Thickness and Its Correlations With Ocular Parameters in Cases With Primary Open-angle Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Brimonidine Tartrate; Drug: Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops; Drug: Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension; Drug: Travoprost and Timolol; Drug: Bimatoprost and Timolol; Drug: Latanoprost

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).

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Primary open-angle glaucoma; Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants.	Drug: Brimonidine Tartrate; Brimonidine tartrate 0.15% 1 eye drop, every day for 6-months; Other Names: Brimonidine Tartrate 0.15%; Drug: Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops; Dorzolamide and timolol fixed combination 2 eye drops, every day for 6 months; Other Names: Dorzolamide and timolol fixed combination; Drug: Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension; Brinzolamide and timolol fixed combination 2 eye drops, every day for 6 months; Other Names: Brinzolamide and timolol fixed combination; Drug: Travoprost and Timolol; Travoprost and Timolol fixed combination 1 eye drop, every day for 6 months; Other Names: Travoprost 0.004%/timolol 0.5% fixed combination; Drug: Bimatoprost and Timolol; Bimatoprost and Timolol fixed combination 1 eye drop, every day for 6 months; Other Names: Bimatoprost 0.03%/timolol 0.5% fixed combination; Drug: Latanoprost; Latanoprost 0.005% 1 eye drop, every day for 6 months; Other Names: Latanoprost 0.005%
NO_INTERVENTION: Healthy; Healthy volunteers who do not have systemic disease that may affect the choroidal thickness and have no ocular features that may affect test measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 1-month, 3-month, 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)	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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 6-month
Changes in the mean cup volume [mm3]	Measuring cup volume [mm3] at 1-month, at 3-month and at 6-month	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 6-month
Changes in the mean disc area [mm2]	Measuring disc area [mm2] at 1-month, at 3-month and at 6-month	Baseline, 1-month, 3-month, 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	Baseline, 1-month, 3-month, 6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-corrected visual acuity measure	Comparison of the mean best-corrected visual acuities at 1-month, at 3-month and at 6-month	Baseline, 1-month, 3-month, 6-month
Intraocular pressure measure	Measuring intraocular pressure at 1-month, at 3-month and at 6-month	Baseline, 1-month, 3-month, 6-month
Correlations between choroidal thickness and other parameters	Analyze correlations between changes of choroidal thicknesses and changes of other parameters during the study.	Baseline, 6-month

Collaborators and Investigators

• Sponsor: Afyon Kocatepe University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (ACTUAL): May 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: optical coherence tomography; choroidal thickness; multifocal electroretinography; optic nerve head; primer open-angle glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Carbonic Anhydrase Inhibitors; Pharmaceutical Solutions; Timolol; Brimonidine Tartrate; Dorzolamide; Ophthalmic Solutions; Travoprost; Brinzolamide; Bimatoprost; Latanoprost
• Other Study ID Numbers: KAEK-2014/04-74

Drug and device information, study documents

• 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