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Spectral Domain Optical Coherence Tomography Analysis for Glaucoma

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ClinicalTrials.gov Identifier: NCT01612416
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : June 5, 2012
Sponsor:
Information provided by (Responsible Party):
Penpe Gul Firat, Inonu University

Tracking Information
First Submitted Date  ICMJE May 31, 2012
First Posted Date  ICMJE June 5, 2012
Last Update Posted Date June 5, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2012)
Ganglion cell complex, retinal nerve fiber layer and retinal thickness measurements of glaucoma patients using spectral domain OCT. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spectral Domain Optical Coherence Tomography Analysis for Glaucoma
Official Title  ICMJE Comparison of Ganglion Cell and Retinal Nerve Fiber Layer Thickness in Primary Open Angle Glaucoma and Normal Tension Glaucoma With Spectral Domain OCT
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE GLAUCOMA 1, OPEN ANGLE, D (Disorder)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Sham Comparator: Normal subjects
    Intervention: Device: RS-3000 OCT measurements
  • Active Comparator: Primary open angle glaucoma
    Intervention: Device: RS-3000 OCT measurements
  • Active Comparator: Normal tension glaucoma
    Intervention: Device: RS-3000 OCT measurements
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2012)
169
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 28 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01612416
Other Study ID Numbers  ICMJE TOTM 021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Penpe Gul Firat, Inonu University
Study Sponsor  ICMJE Inonu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Inonu University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP