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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03394521
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : March 6, 2018
Queen's University, Belfast
Information provided by (Responsible Party):
University of Aberdeen

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.

Condition or disease Intervention/treatment
Glaucoma 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.

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Study Type : Observational
Actual Enrollment : 326 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Progression Evaluation in Glaucoma (PEG): Progression of Disease in Patients Newly Diagnosed With Glaucoma and Glaucoma Suspects Participating in the GATE Study
Study Start Date : October 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Intervention Details:
  • Other: Routine clinical practice
    This is an observational study

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03394521

Sponsors and Collaborators
University of Aberdeen
Queen's University, Belfast
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Principal Investigator: Katie Banister University of Aberdeen

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Responsible Party: University of Aberdeen Identifier: NCT03394521     History of Changes
Other Study ID Numbers: 02/019/15
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Aberdeen:
glaucoma suspect
ocular hypertension

Additional relevant MeSH terms:
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Disease Progression
Ocular Hypertension
Eye Diseases
Disease Attributes
Pathologic Processes