Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

GLAUCOMA 1, OPEN ANGLE, D (Disorder) Clinical Trial

Official title:

Comparison of Ganglion Cell and Retinal Nerve Fiber Layer Thickness in Primary Open Angle Glaucoma and Normal Tension Glaucoma With Spectral Domain OCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612416
• Other study ID #: TOTM 021
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: June 3, 2012
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 28 Years to 72 Years

Eligibility

Inclusion Criteria:

The POAG group inclusion criteria were;

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Glaucoma
• GLAUCOMA 1, OPEN ANGLE, D (Disorder)
• Glaucoma, Open-Angle

Intervention

Device:
• 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

Locations

Country	Name	City	State
Turkey	Inonu University School of Medicine	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ojima T, Tanabe T, Hangai M, Yu S, Morishita S, Yoshimura N. Measurement of retinal nerve fiber layer thickness and macular volume for glaucoma detection using optical coherence tomography. Jpn J Ophthalmol. 2007 May-Jun;51(3):197-203. Epub 2007 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ganglion cell complex, retinal nerve fiber layer and retinal thickness measurements of glaucoma patients using spectral domain OCT.		1 year	Yes