The Effect of Pseudoexfoliation on Choroidal Thickness in Open Angle Glaucoma

NCT03373942 | Completed

• 1 other identifier: 256/30.12.2015
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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 control group. Macular choroidal thickness was measured using a Cirrus HD spectral domain optical coherence tomography (OCT) instrument.

Conditions

Glaucoma, Open-Angle

Keywords

glaucoma; EDI OCT; pseudoexfoliation; choroidal thickness

Outcome Measures

Primary Outcomes (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

  Between August 2014 and February 2015

Study Arms (3)

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

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

Other: Choroidal thickness measurements with SD-OCT device

Control

The control group included 30 eyes of 30 healthy individuals with similar age distribution with POAG and PEX group

Other: Choroidal thickness measurements with SD-OCT device

Interventions

Choroidal thickness measurements with SD-OCT device OTHER

Also known as: General ophthalmological examination, Visual field examination, Optical biometry

Control; Primary Open Angle Glaucoma (POAG); Pseudoexfoliation Syndrome (PEX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emine Deniz Egrilmez: lead
• Izmir Ataturk Training and Research Hospital: collaborator

Related Publications (16)

• 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.

  PMID: 25594764 BACKGROUND

• 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.

  PMID: 25228963 BACKGROUND

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

  PMID: 11166342 BACKGROUND

• 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.

  PMID: 9054481 BACKGROUND

• 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.

  PMID: 20591395 BACKGROUND

• 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.

  PMID: 19232559 BACKGROUND

• 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.

  PMID: 25943737 RESULT

• 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.

  PMID: 25122536 RESULT

• 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.

  PMID: 25059402 RESULT

• 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.

  PMID: 24729143 RESULT

• 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.

  PMID: 25853396 RESULT

• 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.

  PMID: 27007173 RESULT

• 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.

  PMID: 25676024 RESULT

• 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.

  PMID: 26035419 RESULT

• 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.

  PMID: 27077400 RESULT

• Mwanza JC, Hochberg JT, Banitt MR, Feuer WJ, Budenz DL. Lack of association between glaucoma and macular choroidal thickness measured with enhanced depth-imaging optical coherence tomography. Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3430-5. doi: 10.1167/iovs.10-6600.

  PMID: 21357398 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Seyda K Ugurlu, Prof

  Izmir Katip Celebi University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 14, 2017
• Study Start: August 15, 2014
• Primary Completion: February 15, 2015
• Study Completion: August 15, 2015
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share