Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Penpe Gul Firat, Inonu University
ClinicalTrials.gov Identifier:
NCT01612416
First received: May 31, 2012
Last updated: June 3, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
GLAUCOMA 1, OPEN ANGLE, D (Disorder)
Device: RS-3000 OCT measurements

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Inonu University:

Primary Outcome Measures:
  • Ganglion cell complex, retinal nerve fiber layer and retinal thickness measurements of glaucoma patients using spectral domain OCT. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 169
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Normal subjects 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
Other Name: GCC and RNFL in Open Angle and Normal Tension Glaucoma.
Active Comparator: Primary open angle glaucoma 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
Other Name: GCC and RNFL in Open Angle and Normal Tension Glaucoma.
Active Comparator: Normal tension glaucoma 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
Other Name: GCC and RNFL in Open Angle and Normal Tension Glaucoma.

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.

  Eligibility

Ages Eligible for Study:   28 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612416

Locations
Turkey
Inonu University School of Medicine
Malatya, Turkey, 44280
Sponsors and Collaborators
Inonu University
Investigators
Study Director: Penpe G Firat, M.D. Assistant Professor
Principal Investigator: Selim Doganay, M.D Professor
Principal Investigator: Ersan E Demirel, M.D. Resident
Study Chair: Cemil Colka, M.D. Associate Professor
  More Information

Publications:
Responsible Party: Penpe Gul Firat, Principal Investigator, Inonu University
ClinicalTrials.gov Identifier: NCT01612416     History of Changes
Other Study ID Numbers: TOTM 021
Study First Received: May 31, 2012
Last Updated: June 3, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Inonu University:
Ganglion Cell complex, Retinal Nerve Fiber Layer,Glaucoma

Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases

ClinicalTrials.gov processed this record on April 17, 2014