NCT01612416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

7 months

First QC Date

May 31, 2012

Last Update Submit

June 3, 2012

Conditions

GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Keywords

Ganglion Cell complex, Retinal Nerve Fiber Layer,Glaucoma

Outcome Measures

Primary Outcomes (1)

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

    1 year

Study Arms (3)

Normal subjects

SHAM COMPARATOR
Device: RS-3000 OCT measurements

Primary open angle glaucoma

ACTIVE COMPARATOR
Device: RS-3000 OCT measurements

Normal tension glaucoma

ACTIVE COMPARATOR
Device: RS-3000 OCT measurements

Interventions

RS-3000 OCT measurementsDEVICE

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

Also known as: GCC and RNFL in Open Angle and Normal Tension Glaucoma.
Normal subjectsNormal tension glaucomaPrimary open angle glaucoma

Eligibility Criteria

Age28 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University School of Medicine

Malatya, 44280, Turkey (Türkiye)

Location

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

    PMID: 17554482BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Penpe G Firat, M.D.

    Assistant Professor

    STUDY DIRECTOR

  • Selim Doganay, M.D

    Professor

    PRINCIPAL INVESTIGATOR

  • Ersan E Demirel, M.D.

    Resident

    PRINCIPAL INVESTIGATOR

  • Cemil Colka, M.D.

    Associate Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 5, 2012

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

TU(1)