ClinicalTrials.gg
CompletedNCT03394521PEGUpdated May 14, 2026

Progression of Disease in Patients Newly Diagnosed With Glaucoma and Glaucoma Suspects Participating in the GATE Study

An observational study in Glaucoma, sponsored by University of Aberdeen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University of Aberdeen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
326
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In the UK, patients with possible signs of glaucoma or ocular hypertension (OHT) are usually picked up at a routine sight test at their optician or general practitioner. These patients are usually diagnosed in secondary care hospital eye services by an ophthalmologist.

In addition to those diagnosed with OHT and glaucoma there are a large group of patients who have ocular characteristics similar to those found in glaucoma patients, but could also represent variations in normality. In this group, 'glaucoma suspects', monitoring in secondary care for a number of years is recommended in order to establish whether they have glaucoma or if after several years of monitoring there are no clear signs of glaucoma the patient may be discharged.

In our study we will conduct a case-note review of a well-defined cohort of patients who were first identified through a diagnostic accuracy study (the GATE study). This includes (1) patients with OHT, (2) patients identified as glaucoma suspects and (3) patients diagnosed with glaucoma. We will investigate how many patients have experience worsening disease and how many patients have been discharged due to a low risk of glaucoma. We will also investigate the relationship between baseline demographic characteristics and characteristics of the eye and progression of disease.

02

Conditions studied

  • Glaucoma

Keywords

  • glaucoma suspect
  • ocular hypertension
  • progression
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's enrollment of 326 is above the median of 101 across 385 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

University of Aberdeen is the lead sponsor of 176 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Eligibility for patients to be recruited into the GATE study was as follows:

Inclusion criteria

Inclusion criteria:

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

Exclusion criteria

Exclusion criteria:

  • Patients referred to hospital eye services because of other ocular disease;
  • patients \< 18 years old;
  • patients who cannot give ,
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
326 participants (actual)
Patient registry
No

Interventions

  • OtherRoutine clinical practice

    This is an observational study

06

What researchers measure

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

    Time frame: 4 years

Secondary outcomes

  1. Progression of glaucoma

    Proportion of the cohort of glaucoma patients with progression of disease up to 4 years

    Time frame: 1,2,3,4 years

  2. Predictors of disease progression

    Evaluation of predictors of disease progression from baseline demographic and ocular characteristics

    Time frame: 4 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2015, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2017
First posted
Jan 9, 2018
Start
Oct 2015
Primary completionActual
Aug 2016
CompletionActual
Aug 2016
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03394521
Responsible party
Sponsor
First posted
Jan 9, 2018
Start date
Oct 2015
Primary completion
Aug 2016
Completion
Aug 2016
Last update
May 14, 2026

Study contacts

Katie Banister
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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