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OpenTrials
Completed

NCT Number: NCT03966560

Choroidal Thickness and Its Correlations With Ocular Parameters in 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brimonidine Tartrate

Drug

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

Other names: Brimonidine Tartrate 0.15%

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

Other names: Dorzolamide and timolol fixed combination

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

Other names: Brinzolamide and timolol fixed combination

Travoprost and Timolol

Drug

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

Other names: Travoprost 0.004%/timolol 0.5% fixed combination

Bimatoprost and Timolol

Drug

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

Other names: Bimatoprost 0.03%/timolol 0.5% fixed combination

latanoprost

Drug

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

Other names: Latanoprost 0.005%

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Afyon Kocatepe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 29, 2019
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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