Trial Outcomes & Findings for Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye (NCT NCT02622191)

Last Updated: 2019-03-15

Results Overview

Using Spectral Domain optical coherence tomography (SD-OCT), horizontal macular thickness of the lamina cribrosa (boundaries of the retinal layers) is measured in the eyes of each participant in microohms.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

1 examination, approximately one hour

Results posted on

2019-03-15

Participant Flow

Participants with unilateral primary open-angle glaucoma (POAG) were recruited from the Glaucoma Service at Wills Eye Hospital, Philadelphia, PA, USA. Healthy controls were recruited from staff, friends and family. All participants were recruited between November 2012 and February 2013.

Participant milestones

Participant milestones
Measure	Open-angle Glaucoma Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient. Spectral domain Optical Coherence Tomography (SD-OCT): Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea were acquired using Spectralis Heidelberg Retinal Angiography (HRA)+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany).	Healthy Controls Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control. Spectral domain Optical Coherence Tomography (SD-OCT): Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea were acquired using Spectralis Heidelberg Retinal Angiography (HRA)+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany).
Overall Study STARTED	19	14
Overall Study COMPLETED	19	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-angle Glaucoma n=19 Participants Participants with primary open-angle glaucoma and an abnormal visual field defect in one eye. Spectral domain Optical Coherence Tomography will be obtained from the effected eye and fellow eye of each glaucoma patient. Spectral domain Optical Coherence Tomography: Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea.	Healthy Controls n=14 Participants Participants without glaucoma and no other eye diseases. Spectral domain Optical Coherence Tomography will be obtained from eyes of each healthy control. Spectral domain Optical Coherence Tomography: Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 examination, approximately one hour

Outcome measures

Outcome measures
Measure	Open-angle Glaucoma Affected Eye n=19 Participants Affected eye of patients with primary open-angle glaucoma and visual field defect.	Healthy Controls n=14 Participants Eyes of healthy controls with no glaucoma or other eye diseases.	Open-angle Glaucoma Fellow Eye n=19 Participants Fellow eye of patients with primary open-angle glaucoma and no visual field defect.
Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements	264.3 micro-ohms Interval 258.3 to 270.3	273.3 micro-ohms Interval 265.4 to 281.1	276.2 micro-ohms Interval 270.0 to 282.4

Adverse Events

Open-angle Glaucoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. L. Jay Katz

Wills Eye Hospital, Glaucoma Research Center

Phone: 215-928-3123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place