Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-06-30

Brief Summary

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The aim of this study is to examine whether there is a difference in macular ganglion cell complex thickness and retinal nerve fiber layer thickness in early-stage Primary open angle glaucoma and normal tension glaucoma with spectral domain OCT.

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Detailed Description

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Glaucoma is a progressive optic neuropathy characterized by gradual degeneration of neuronal tissue in which retinal ganglion cells (RGCs) are injured, leading to the loss of the visual field.Recent studies have separately demonstrated a reduction in the macular retinal thickness and in the retinal nerve fibers in both POAG and NTG.It has been demonstrated that in early stage NTG macular GCC thickness showed a strong correlation with thickness of the RNFL. However there have yet to be any reports regarding the comparison of macular thickness, ganglion cell complex and retinal nerve fiber layer between POAG and NTG with RS-3000 RetinaScan at early stage.

Conditions

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GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Normal subjects

Group Type SHAM_COMPARATOR

RS-3000 OCT measurements

Intervention Type DEVICE

Ganglion cell, retinal nerve fiber layer and retinal thickness measurements of normal subjects, primary open angle glaucoma and normal tension glaucoma patients using RS-3000 OCT RetinaScan

Primary open angle glaucoma

Group Type ACTIVE_COMPARATOR

RS-3000 OCT measurements

Intervention Type DEVICE

Ganglion cell, retinal nerve fiber layer and retinal thickness measurements of normal subjects, primary open angle glaucoma and normal tension glaucoma patients using RS-3000 OCT RetinaScan

Normal tension glaucoma

Group Type ACTIVE_COMPARATOR

RS-3000 OCT measurements

Intervention Type DEVICE

Ganglion cell, retinal nerve fiber layer and retinal thickness measurements of normal subjects, primary open angle glaucoma and normal tension glaucoma patients using RS-3000 OCT RetinaScan

Interventions

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RS-3000 OCT measurements

Ganglion cell, retinal nerve fiber layer and retinal thickness measurements of normal subjects, primary open angle glaucoma and normal tension glaucoma patients using RS-3000 OCT RetinaScan

Intervention Type DEVICE

Other Intervention Names

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GCC and RNFL in Open Angle and Normal Tension Glaucoma.

Eligibility Criteria

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Inclusion Criteria

* IOP higher than 21 mmHg before treatment on three different visits,
* Best corrected VA of 20/25 or better with a spherical equivalent within ±5 D and a cylinder correction within +3 D;
* An open angle confirmed by gonioscopy.
* Glaucomatous optic disc damage defined as by the presence of glaucomatous optic neuropathy like rim thinning (diffuse or local), cupping, notching, and a cup/disc ratio \>0.2 with asymmetry.

NTG group were included if;

• They had the same optic disc and visual field criteria as for the POAG patients with the exception that their IOP was as ≤21 mmHg on three separate visits without any glaucomatous treatment.

The control group

* Who had no ocular disease
* Who had not undergone ocular surgery or laser procedures.
* With a normal anterior segment, open angles, and normal posterior segment findings also normal optic nerve head appearance in their ophthalmic examination.
* The IOP measurements were lower than 21 mmHg, and full-threshold 30-2 HFA were also within normal limits in the control group.

Exclusion Criteria

* Subjects with any retinal disease, diabetes mellitus, or neurological disease or who had undergone ocular surgery and laser procedures.
* Subjects with pseudoexfoliation glaucoma and pigmentary glaucoma were excluded.

Minimum Eligible Age

28 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes