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Clinical Trials/NCT03373942
NCT03373942CompletedNot Applicable

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

Emine Deniz Egrilmez0 sites90 target enrollmentStarted: August 15, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Primary Endpoint
The Effect of Pseudoexfoliation on Choroidal Thickness in Open Angle Glaucoma

Study Overview

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.

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Emine Deniz Egrilmez
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Emine Deniz Egrilmez

M.D.

Izmir Ataturk Training and Research Hospital

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