NCT02547740

Brief Summary

Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. There is scientific evidence that the macula, the central part of the retina, can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very prevalent and is often missed using conventional clinical tests. Relatively little is known about progression of early glaucoma damage and its effects on the macula. This project investigates the nature of progressive damage to the macula and proposes new methods to improve accuracy to detect clinically significant progression.The study will evaluate the nature of damage to the macula's structures through OCT imaging and eye function via visual field tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

September 10, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

8.3 years

First QC Date

September 10, 2015

Last Update Submit

May 13, 2024

Conditions

Glaucoma

Keywords

maculavisual fieldsoptical coherence tomographyglaucoma progressionretinal ganglion cells

Outcome Measures

Primary Outcomes (2)

  • Change in 10-2 visual field

    Evidence of functional glaucomatous damage on the macula as confirmed by visual fields: A slope of 10-2 visual field change faster than -1 dB/year at P\<5%

    Baseline and 3 years

  • Change in macular ganglion cell thickness

    Evidence of structural glaucomatous damage on the macula as confirmed by OCT imaging: evidence of macular ganglion cell thickness slope less than -10 microns/year

    Baseline and 3 years

Study Arms (2)

Early Glaucomatous Damage

Patients with early functional glaucomatous damage.

Ophthalmologically Healthy

Healthy subjects that are ophthalmologically normal

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen in Columbia eye clinics and enrolled in cross-sectional database; Columbia University Medical Center Eye Institute.

You may qualify if:

  • glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria)

You may not qualify if:

  • late functional glaucomatous damage
  • significant cataract
  • previous ocular surgery (aside from uncomplicated cataract extraction with intraocular lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)
  • diabetic retinopathy with macular edema
  • vein or artery occlusion
  • exudative age-related macular degeneration or geographic atrophy
  • macular hole or traction
  • amblyopia
  • uveitis
  • non-open angle glaucoma (e.g. angle closure, traumatic, congenital glaucoma)
  • severe myopia or hyperopia (refractive error greater than -6 or +6D, respectively)
  • retinal detachment (current or post-surgery)
  • retinitis pigmentosa
  • significant epiretinal memberane
  • significant kerotoconus
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUIMC Harkness Eye Institute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Hood DC, Tsamis E, Bommakanti NK, Joiner DB, Al-Aswad LA, Blumberg DM, Cioffi GA, Liebmann JM, De Moraes CG. Structure-Function Agreement Is Better Than Commonly Thought in Eyes With Early Glaucoma. Invest Ophthalmol Vis Sci. 2019 Oct 1;60(13):4241-4248. doi: 10.1167/iovs.19-27920.

    PMID: 31618760DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jeffrey Liebmann, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 11, 2015

Study Start

October 1, 2015

Primary Completion

January 18, 2024

Study Completion

January 18, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)