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Completed

NCT Number: NCT03394521

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Clinical Practice

Other

This is an observational study

Primary outcomes

  1. Development of glaucoma

    Time frame: 4 years

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

Secondary outcomes

  1. Progression of glaucoma

    Time frame: 1,2,3,4 years

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

  2. Predictors of disease progression

    Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • Queen's University, Belfast

Registry information

Official study title

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

Acronym: PEG

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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