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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03394521
Acronym
PEG
Enrollment
326
Registered
2018-01-09
Start date
2015-10-01
Completion date
2016-08-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

glaucoma suspect, ocular hypertension, progression

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.

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.

Interventions

This is an observational study

Sponsors

University of Aberdeen
Lead SponsorOTHER
Queen's University, Belfast
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Development of glaucoma4 yearsProportion of glaucoma suspects and OHT patients who develop glaucoma annually up to 4 years after diagnosis in secondary care

Secondary

MeasureTime frameDescription
Progression of glaucoma1,2,3,4 yearsProportion of the cohort of glaucoma patients with progression of disease up to 4 years
Predictors of disease progression4 yearsEvaluation of predictors of disease progression from baseline demographic and ocular characteristics

Contacts

PRINCIPAL_INVESTIGATORKatie Banister

University of Aberdeen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026