Trial | NCT03966560  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    96
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.
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 Started
Jan 31
2014
Primary Completion
Jan 31
2015
Study Completion
Apr 30
2015
Last Update
May 29
2019

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 (azopt), timolol (blocadren)]

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 (travatan), timolol (blocadren)]

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 (lumigan), timolol (blocadren)]

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%

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.

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.

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
No Results Posted