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Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

Primary Purpose

GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

RS-3000 OCT measurements

About this trial

This is an interventional screening trial for GLAUCOMA 1, OPEN ANGLE, D (Disorder) focused on measuring Ganglion Cell complex, Retinal Nerve Fiber Layer,Glaucoma

Eligibility Criteria

28 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Inonu University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Arm Label

Normal subjects

Primary open angle glaucoma

Normal tension glaucoma

Arm Description

Outcomes

Primary Outcome Measures

Ganglion cell complex, retinal nerve fiber layer and retinal thickness measurements of glaucoma patients using spectral domain OCT.

Secondary Outcome Measures

Full Information

NCT ID

NCT01612416

First Posted

May 31, 2012

Last Updated

June 3, 2012

Sponsor

Inonu University

1. Study Identification

Unique Protocol Identification Number

NCT01612416

Brief Title

Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Inonu University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Keywords

Ganglion Cell complex, Retinal Nerve Fiber Layer,Glaucoma

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal subjects

Arm Type

Sham Comparator

Arm Title

Primary open angle glaucoma

Arm Type

Active Comparator

Arm Title

Normal tension glaucoma

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

RS-3000 OCT measurements

Other Intervention Name(s)

GCC and RNFL in Open Angle and Normal Tension Glaucoma.

Intervention Description

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 Outcome Measure Information:

Title

Ganglion cell complex, retinal nerve fiber layer and retinal thickness measurements of glaucoma patients using spectral domain OCT.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Penpe G Firat, M.D.

Organizational Affiliation

Assistant Professor

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Selim Doganay, M.D

Organizational Affiliation

Professor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ersan E Demirel, M.D.

Organizational Affiliation

Resident

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cemil Colka, M.D.

Organizational Affiliation

Associate Professor

Official's Role

Study Chair

Facility Information:

Facility Name

Inonu University School of Medicine

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

17554482

Citation

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. doi: 10.1007/s10384-006-0433-y. Epub 2007 Jun 7.

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Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

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