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

May 24, 2019 updated by: Afyon Kocatepe University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Macular choroidal thickness measure
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
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)
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
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]
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
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]
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
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]
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
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]
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
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]
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
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
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
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])
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
Baseline, 1-month, 3-month, 6-month
Changes in the mean neuroretinal rim area [mm2])
Time Frame: Baseline, 1-month, 3-month, 6-month
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]
Time Frame: Baseline, 1-month, 3-month, 6-month
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
Time Frame: Baseline, 1-month, 3-month, 6-month
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]
Time Frame: Baseline, 1-month, 3-month, 6-month
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]
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
Baseline, 1-month, 3-month, 6-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity measure
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
Baseline, 1-month, 3-month, 6-month
Intraocular pressure measure
Time Frame: Baseline, 1-month, 3-month, 6-month
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
Time Frame: Baseline, 6-month
Analyze correlations between changes of choroidal thicknesses and changes of other parameters during the study.
Baseline, 6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Afyon Kocatepe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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