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

NCT03966560 | Completed Phase 4 FDA Drug

• 1 other identifier: KAEK-2014/04-74
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma, Open-Angle

Keywords

choroidal thickness; multifocal electroretinography; optic nerve head; optical coherence tomography; primer open-angle glaucoma

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (3)

• Best-corrected visual acuity measure

  Baseline, 1-month, 3-month, 6-month

• Intraocular pressure measure

  Baseline, 1-month, 3-month, 6-month

• Correlations between choroidal thickness and other parameters

  Baseline, 6-month

Study Arms (2)

Primary open-angle glaucoma

EXPERIMENTAL

Participants over 40 years of age and diagnosed with primary open-angle glaucoma. Medical treatment was initiated for the diagnosed participants.

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

Healthy

NO INTERVENTION

Healthy volunteers who do not have systemic disease that may affect the choroidal thickness and have no ocular features that may affect test measurements.

Interventions

Brimonidine Tartrate DRUG

Brimonidine tartrate 0.15% 1 eye drop, every day for 6-months

Also known as: Brimonidine Tartrate 0.15%

Primary open-angle glaucoma

Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops DRUG

Dorzolamide and timolol fixed combination 2 eye drops, every day for 6 months

Also known as: Dorzolamide and timolol fixed combination

Primary open-angle glaucoma

Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension DRUG

Brinzolamide and timolol fixed combination 2 eye drops, every day for 6 months

Also known as: Brinzolamide and timolol fixed combination

Primary open-angle glaucoma

Travoprost and Timolol DRUG

Travoprost and Timolol fixed combination 1 eye drop, every day for 6 months

Also known as: Travoprost 0.004%/timolol 0.5% fixed combination

Primary open-angle glaucoma

Bimatoprost and Timolol DRUG

Bimatoprost and Timolol fixed combination 1 eye drop, every day for 6 months

Also known as: Bimatoprost 0.03%/timolol 0.5% fixed combination

Primary open-angle glaucoma

Latanoprost DRUG

Latanoprost 0.005% 1 eye drop, every day for 6 months

Also known as: Latanoprost 0.005%

Primary open-angle glaucoma

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• The best corrected visual acuity (BCVA) of 0.8 and above
• Presence of systemic disease that may affect choroid blood flow
• Ocular conditions that may affect test measurements

Sponsors & Collaborators

• Afyon Kocatepe University Hospital: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Brimonidine Tartrate; dorzolamide; Timolol; Ophthalmic Solutions; brinzolamide; Duotrav; Travoprost; Ganfort; Bimatoprost; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective controlled clinical trial

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 29, 2019
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 29, 2019

Record last verified: 2019-05