NCT03394521

Brief Summary

The purpose of this study is to measure how many patients develop worsening glaucoma in the early years (2-4 years) of routine monitoring in hospital eye services. We will study a group of patients who were initially diagnosed as having glaucoma, or having high pressure in the eye (ocular hypertension) or having been diagnosed as a glaucoma suspect.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

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

October 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

May 22, 2017

Last Update Submit

March 5, 2018

Conditions

Keywords

glaucoma suspectocular hypertensionprogression

Outcome Measures

Primary Outcomes (1)

  • Development of glaucoma

    Proportion of glaucoma suspects and OHT patients who develop glaucoma annually up to 4 years after diagnosis in secondary care

    4 years

Secondary Outcomes (2)

  • Progression of glaucoma

    1,2,3,4 years

  • Predictors of disease progression

    4 years

Interventions

This is an observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cohort of patients identified through the GATE study - newly referred from community to hospital eye services with suspected glaucoma

You may qualify if:

  • \- Adults referred from community optometrists or general practitioner to hospital eye services with suspected glaucoma, including those with ocular hypertension.

You may not qualify if:

  • Patients referred to hospital eye services because of other ocular disease;
  • patients \< 18 years old;
  • patients who cannot give informed consent,
  • patients already diagnosed with glaucoma.
  • This study cohort is further defined from the GATE population as
  • Selection criteria:
  • GATE study patients with a baseline diagnosis of OHT, Glaucoma suspect or Glaucoma (any mechanism);
  • remaining in secondary care monitoring after first visit;
  • recruited at Aberdeen Royal Infirmary or Hinchingbrooke Hospital NHS Trust.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlaucomaOcular HypertensionDisease Progression

Condition Hierarchy (Ancestors)

Eye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katie Banister

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

January 9, 2018

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 6, 2018

Record last verified: 2018-03