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Glaucoma, Open-AngleNCT03373942

The Effect of Pseudoexfoliation on Choroidal Thickness in Open Angle Glaucoma

An observational study of Glaucoma, Open-Angle, run by Emine Deniz Egrilmez.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: To investigate the effect of pseudoexfoliation (PEX) on choroidal thickness in primary open-angle glaucoma (POAG). Methods: This prospective, randomized study included 30 POAG patients and 30 PEX glaucoma patients with similar demographic characteristics, and 30 eyes of 30 healthy individuals comprised the… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Glaucoma, Open-Angle
What is being tested?
Choroidal thickness measurements with SD-OCT device
How many people
90 participants
Where
No sites listed yet
Study dates
15 Aug 2014to 15 Aug 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: POAG was diagnosed based on high IOP (>21 mmHg) at the time of diagnosis, typical glaucomatous optic disc and visual field changes, and normal anterior chamber angle. In contrast, PEX glaucoma diagnosis was based on high IOP (>21 mmHg) at diagnosis and typical glaucomatous optic disc and visual field changes, plus the presence of PEX material or hyperpigmentation in the anterior chamber angle and the presence of PEX material at the pupillary margins or the anterior lens on anterior segment examination after pupil dilation. The control group consisted of healthy individuals with normal anterior and posterior segment findings and IOP less than 21 mmHg.

Who may be able to join

  • The study included subjects over 18 years old who had best corrected visual acuity of 0.5 or better, transparent optic medium, at least two reliable visual field tests, and reliable spectral domain (SD)-OCT (signal strength≥7/10) and EDI-OCT images (signal strength≥6/10)

Who cannot join

  • Information pertaining to patients' systemic diseases and chronic medication use was recorded. Patients with diabetes mellitus, systemic arterial hypertension, renal failure, hemodialysis history, chronic medication, or smoking habit were not included.
  • Patients with retinal and neuro-ophthalmological diseases, amblyopia, active or previous uveitis, previous ocular trauma, intraocular surgery within last 6 months, previous trabeculectomy, or refractive error with a spherical equivalent greater than ±3.0 D were excluded from the study. In order to minimize the effect of IOP on choroidal thickness, patients with IOP higher than 21 mmHg at the time of OCT image acquisition were not included in the study.

About this study

Official title: Evaluation of Choroidal Thickness Using Spectral Optical Coherence Tomography in Pseudoexfoliation Glaucoma and Primary Open Angle Glaucoma

Purpose: To investigate the effect of pseudoexfoliation (PEX) on choroidal thickness in primary open-angle glaucoma (POAG).

Methods: This prospective, randomized study included 30 POAG patients and 30 PEX glaucoma patients with similar demographic characteristics, and 30 eyes of 30 healthy individuals comprised the control group. Macular choroidal thickness was measured using a Cirrus HD spectral domain optical coherence tomography (OCT) instrument.

Read the detailed description

In the present study, the investigators aimed to evaluate the effect of the presence of PEX on choroidal thickness in two groups of glaucoma patients with similar degrees of damage and similar demographical characteristics. The investigators also evaluated whether there was a correlation between choroidal thickness and indicators of glaucoma severity, such as retinal nerve fiber layer (RNFL) thickness and mean deviation (MD) value, in these two glaucoma types.

MATERIALS AND METHODS The study included 30 eyes of 30 patients diagnosed with POAG and 30 eyes of 30 patients diagnosed with PEX glaucoma who presented to Glaucoma Unit of Izmir Katip Celebi University Atatürk Training and Research Hospital between August 2014 and February 2015. The control group included 30 eyes of 30 healthy individuals with similar age distribution.

Approval was obtained from the ethics committee of Izmir Katip Celebi University Medical School Atatürk Training and Research Hospital. Detailed informed consent forms were obtained from each of the patients included in the study.

The study included subjects over 18 years old who had best corrected visual acuity of 0.5 or better, transparent optic medium, at least two reliable visual field tests, and reliable spectral domain (SD)-OCT (signal strength≥7/10) and EDI-OCT images (signal strength≥6/10) Information pertaining to patients' systemic diseases and chronic medication use was recorded. Patients with diabetes mellitus, systemic arterial hypertension, renal failure, hemodialysis history, chronic medication, or smoking habit were not included.

Patients with retinal and neuro-ophthalmological diseases, amblyopia, active or previous uveitis, previous ocular trauma, intraocular surgery within last 6 months, previous trabeculectomy, or refractive error with a spherical equivalent greater than ±3.0 D were excluded from the study. In order to minimize the effect of IOP on choroidal thickness, patients with IOP higher than 21 mmHg at the time of OCT image acquisition were not included in the study.

POAG was diagnosed based on high IOP (>21 mmHg) at the time of diagnosis, typical glaucomatous optic disc and visual field changes, and normal anterior chamber angle. In contrast, PEX glaucoma diagnosis was based on high IOP (>21 mmHg) at diagnosis and typical glaucomatous optic disc and visual field changes, plus the presence of PEX material or hyperpigmentation in the anterior chamber angle and the presence of PEX material at the pupillary margins or the anterior lens on anterior segment examination after pupil dilation. The control group consisted of healthy individuals with normal anterior and posterior segment findings and IOP less than 21 mmHg.

All subjects underwent a detailed ophthalmologic examination. Axial length was measured using IOL Master (Carl Zeiss Meditec, Dublin, CA, USA) optic biometry. Visual field was assessed with Humphrey II Perimetry (Carl Zeiss Meditec, Dublin, CA, USA) SITA standard central 24-2 test. Tests with fixation loss less than 20%, false negative, and false positive response rates below 33% were considered reliable. Patients with at least two reliable visual field tests were included in the study. MD values were obtained.

Optic disc images were obtained with Cirrus 4000 HD-OCT (Carl ZeissMeditec, Dublin, CA, USA) SD-OCT device. Mean RNFL thickness and vertical cup-to-disc (c/d) ratios were noted. Choroidal imaging was done after pupil dilation using the EDI-OCT mode. The SD Cirrus HD-OCT light source was centered on 800 nm wavelength to achieve 5 μm maximal resolution in tissue. In order to minimize the effect of diurnal choroidal thickness variation on the measurements, choroidal thickness measurements of all patients were made between 09:00 and 11:00 am, after a resting period of 30 minutes. The macular field was scanned in the horizontal plane in high-resolution 1 line raster mode. Patients were asked to focus on the instrument's internal fixation light until the retinal image was acquired. Images with signal strength of 6/10 or better were eligible for assessment. Patients who had at least two reliable high-resolution foveal and choroidal imagings were included in the study.

The fovea centralis was determined by identifying the point of maximum depression in the central 500-micron-diameter area. The internal and external choroidal margins were determined manually in the section passing through the fovea centralis. These margins were drawn based on criteria defined by Boonarpha et al.[15]. The posterior edge of the hyperreflective band corresponding to the retinal pigment epithelium-Bruch's membrane complex was determined as the anterior border of the choriocapillaris. The posterior border of the choriocapillaris was demarcated as the hyperreflective band corresponding to the sclerochoroidal interface or the hyporeflective line corresponding to suprachoroidal space. In cases where these two anatomic structures could not be visualized, measurement was done using the prominent straight line corresponding to the posterior margin of the large choroidal vessels. Patients in whom choroidal margins could not be clearly distinguished were not included in the study.

High-resolution retinal choroidal images with distinct choroidal margins were transferred to ImageJ software [40]. The high-resolution EDI-OCT images were 6000 microns wide and 2000 microns high, as indicated in the manufacturer's user's manual. EDI-OCT images to be measured were opened using ImageJ software. The Scale command was selected in the Image tab of ImageJ software menu. Using the Scale menu, width (pixels) was defined as 6000 and height (pixels) as 2000. The distance to be measured was marked on the new image of 6000x2000 pixels and measurements were done using the Measure command in Analyze tab. The choroidal margins were drawn in this software according to the specified criteria, followed by manual measurements. Measurements were taken vertically at the fovea centralis and in the nasal and temporal quadrants at distances of 1500 and 2500 microns from the fovea centralis. The same researcher repeated the measurements at different times using the double-blind method, and intraobserver and intervisit measurement repeatability was assessed.

All data were analysed using SPSS software. Independent t-test was used to compare the groups. The correlation between choroidal thickness and other variables (age, axial length, vertical c/d, RNFL thickness, MD) was evaluated using Pearson correlation analysis.Repeatability analysis of study parameters measured with Cirrus 4000 HD OCT was evaluated using the coefficient of variation (CV). For CV calculation of choroidal thickness measured by Cirrus 4000 HD OCT, 10 consequential measurements were obtained by the same operator to the same eye of the subject. CV is defined as the ratio of the standard deviation to the mean: cV=σ/μ

Being tested
Choroidal thickness measurements with SD-OCT device
Keywords
glaucoma, EDI OCT, pseudoexfoliation, choroidal thickness
Medical subject headings
Glaucoma, Open-Angle, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Choroidal thickness measurements with SD-OCT deviceOther

    Also called General ophthalmological examination, Visual field examination, Optical biometry

Study groups in NCT03373942
Study groupRoleWhat they receive
Primary Open Angle Glaucoma (POAG)The study included 30 eyes of 30 patients diagnosed with POAG who presented to Glaucoma Unit of İzmir Katip Çelebi University Atatürk Training and Research Hospital
Receives: Other: Choroidal thickness measurements with SD-OCT device
Pseudoexfoliation Syndrome (PEX)The study included 30 eyes of 30 patients diagnosed with PEX glaucoma who presented to Glaucoma Unit of İzmir Katip Çelebi University Atatürk Training and Research Hospital
Receives: Other: Choroidal thickness measurements with SD-OCT device
ControlThe control group included 30 eyes of 30 healthy individuals with similar age distribution with POAG and PEX group
Receives: Other: Choroidal thickness measurements with SD-OCT device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of Pseudoexfoliation on Choroidal Thickness in Open Angle Glaucoma

    Choroidal thicknesses at nasal 2500 µm, nasal 1500 µm, subfoveal, temporal 1500 µm, and temporal 2500 µm in the three groups were measured

    Measured: Between August 2014 and February 2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2017
  2. Study start15 Aug 2014
  3. Primary completion15 Feb 2015
  4. Study completion15 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03373942
Sponsor's protocol ID
256/30.12.2015
Status last verified
Dec 2017
First submitted
6 Nov 2017
Last updated
18 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anastasopoulos E, Founti P, Topouzis F. Update on pseudoexfoliation syndrome pathogenesis and associations with intraocular pressure, glaucoma and systemic diseases. Curr Opin Ophthalmol. 2015 Mar;26(2):82-9. doi: 10.1097/ICU.0000000000000132.

    PubMed 25594764
  • Andrikopoulos GK, Alexopoulos DK, Gartaganis SP. Pseudoexfoliation syndrome and cardiovascular diseases. World J Cardiol. 2014 Aug 26;6(8):847-54. doi: 10.4330/wjc.v6.i8.847.

    PubMed 25228963
  • Ritch R, Schlotzer-Schrehardt U. Exfoliation syndrome. Surv Ophthalmol. 2001 Jan-Feb;45(4):265-315. doi: 10.1016/s0039-6257(00)00196-x.

    PubMed 11166342
  • Konstas AG, Stewart WC, Stroman GA, Sine CS. Clinical presentation and initial treatment patterns in patients with exfoliation glaucoma versus primary open-angle glaucoma. Ophthalmic Surg Lasers. 1997 Feb;28(2):111-7.

    PubMed 9054481
  • Manjunath V, Taha M, Fujimoto JG, Duker JS. Choroidal thickness in normal eyes measured using Cirrus HD optical coherence tomography. Am J Ophthalmol. 2010 Sep;150(3):325-329.e1. doi: 10.1016/j.ajo.2010.04.018. Epub 2010 Jun 29.

    PubMed 20591395
  • Margolis R, Spaide RF. A pilot study of enhanced depth imaging optical coherence tomography of the choroid in normal eyes. Am J Ophthalmol. 2009 May;147(5):811-5. doi: 10.1016/j.ajo.2008.12.008. Epub 2009 Feb 20.

    PubMed 19232559
  • Zhang Z, Yu M, Wang F, Dai Y, Wu Z. Choroidal Thickness and Open-Angle Glaucoma: A Meta-Analysis and Systematic Review. J Glaucoma. 2016 May;25(5):e446-54. doi: 10.1097/IJG.0000000000000275.

    PubMed 25943737
  • Bayhan HA, Bayhan SA, Can I. Evaluation of the Macular Choroidal Thickness Using Spectral Optical Coherence Tomography in Pseudoexfoliation Glaucoma. J Glaucoma. 2016 Feb;25(2):184-7. doi: 10.1097/IJG.0000000000000100.

    PubMed 25122536
  • Zengin MO, Cinar E, Karahan E, Tuncer I, Yilmaz S, Kocaturk T, Kucukerdonmez C. Choroidal thickness changes in patients with pseudoexfoliation syndrome. Int Ophthalmol. 2015 Aug;35(4):513-7. doi: 10.1007/s10792-014-9977-x. Epub 2014 Jul 25.

    PubMed 25059402
  • Goktas S, Sakarya Y, Ozcimen M, Sakarya R, Bukus A, Ivacik IS, Erdogan E. Choroidal thinning in pseudoexfoliation syndrome detected by enhanced depth imaging optical coherence tomography. Eur J Ophthalmol. 2014 Nov-Dec;24(6):879-84. doi: 10.5301/ejo.5000460. Epub 2014 Apr 4.

    PubMed 24729143
  • Eroglu FC, Asena L, Simsek C, Kal A, Yilmaz G. Evaluation of choroidal thickness using enhanced depth imaging by spectral-domain optical coherence tomography in patients with pseudoexfoliation syndrome. Eye (Lond). 2015 Jun;29(6):791-6. doi: 10.1038/eye.2015.34. Epub 2015 Mar 27.

    PubMed 25853396
  • Ozge G, Koylu MT, Mumcuoglu T, Gundogan FC, Ozgonul C, Ayyildiz O, Kucukevcilioglu M. Evaluation of retinal nerve fiber layer thickness and choroidal thickness in pseudoexfoliative glaucoma and pseudoexfoliative syndrome. Postgrad Med. 2016 May;128(4):444-8. doi: 10.1080/00325481.2016.1170579. Epub 2016 Apr 4.

    PubMed 27007173
  • Turan-Vural E, Yenerel N, Okutucu M, Yildiz E, Dikmen N. Measurement of Subfoveal Choroidal Thickness in Pseudoexfoliation Syndrome Using Enhanced Depth Imaging Optical Coherence Tomography. Ophthalmologica. 2015;233(3-4):204-8. doi: 10.1159/000371899. Epub 2015 Feb 7.

    PubMed 25676024
  • Kocabeyoglu S, Uzun S, Kadayifcilar S, Mocan MC, Irkec M. The Relationship Between Choroidal Expansion and Intraocular Pressure Rise During the Water Drinking Test in Healthy Subjects and Patients With Exfoliation Syndrome. J Glaucoma. 2016 Apr;25(4):e324-8. doi: 10.1097/IJG.0000000000000283.

    PubMed 26035419
  • Demircan S, Yilmaz U, Kucuk E, Ulusoy MD, Atas M, Gulhan A, Zararsiz G. The Effect of Pseudoexfoliation Syndrome on the Retinal Nerve Fiber Layer and Choroid Thickness. Semin Ophthalmol. 2017;32(3):341-347. doi: 10.3109/08820538.2015.1090611. Epub 2016 Apr 14.

    PubMed 27077400

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, Open-Angle, run by Emine Deniz Egrilmez.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Effect of Pseudoexfoliation on Choroidal Thickness in Open Angle Glaucoma (time frame: Between August 2014 and February 2015). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03373942, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.

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