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

Progression Evaluation in Glaucoma (PEG): Progression of Disease in Patients Newly Diagnosed With Glaucoma and Glaucoma Suspects Participating in the GATE Study

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Other: Routine clinical practice

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.

• Study Type: Observational
• Enrollment (Actual): 326

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Inclusion criteria:

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

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of glaucoma	Proportion of the cohort of glaucoma patients with progression of disease up to 4 years	1,2,3,4 years
Predictors of disease progression	Evaluation of predictors of disease progression from baseline demographic and ocular characteristics	4 years

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: Queen's University, Belfast
• Investigators: Principal Investigator: Katie Banister, University of Aberdeen

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: ocular hypertension; progression; glaucoma suspect
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Eye Diseases; Pathological Conditions, Signs and Symptoms; Disease Progression; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: 02/019/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED