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Trial record 41 of 1615 for:    glaucoma

The Effect of Pseudoexfoliation on Choroidal Thickness in Open Angle Glaucoma

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ClinicalTrials.gov Identifier: NCT03373942
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Izmir Ataturk Training and Research Hospital
Information provided by (Responsible Party):
Emine Deniz Egrilmez, Izmir Ataturk Training and Research Hospital

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.


Condition or disease Intervention/treatment
Glaucoma, Open-Angle Other: Choroidal thickness measurements with SD-OCT device

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of Choroidal Thickness Using Spectral Optical Coherence Tomography in Pseudoexfoliation Glaucoma and Primary Open Angle Glaucoma
Actual Study Start Date : August 15, 2014
Actual Primary Completion Date : February 15, 2015
Actual Study Completion Date : August 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
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
Other Names:
  • General ophthalmological examination
  • Visual field examination
  • Optical biometry

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
Other Names:
  • General ophthalmological examination
  • Visual field examination
  • Optical biometry

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
Other Names:
  • General ophthalmological examination
  • Visual field examination
  • Optical biometry




Primary Outcome Measures :
  1. The Effect of Pseudoexfoliation on Choroidal Thickness in Open Angle Glaucoma [ Time Frame: Between August 2014 and February 2015 ]
    Choroidal thicknesses at nasal 2500 µm, nasal 1500 µm, subfoveal, temporal 1500 µm, and temporal 2500 µm in the three groups were measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373942


Sponsors and Collaborators
Emine Deniz Egrilmez
Izmir Ataturk Training and Research Hospital
Investigators
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Study Director: Seyda K Ugurlu, Prof Izmir Katip Celebi University Hospital

Publications of Results:

Other Publications:
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Responsible Party: Emine Deniz Egrilmez, M.D., Izmir Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03373942     History of Changes
Other Study ID Numbers: 256/30.12.2015
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emine Deniz Egrilmez, Izmir Ataturk Training and Research Hospital:
glaucoma
EDI OCT
pseudoexfoliation
choroidal thickness

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases