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

Glaucoma Clinical Trial

— PEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394521
• Other study ID #: 02/019/15
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: March 5, 2018
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: March 2018
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease Progression
• Glaucoma

Intervention

Other:
• Routine clinical practice
This is an observational study

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	Queen's University, Belfast

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression of glaucoma	Proportion of the cohort of glaucoma patients with progression of disease up to 4 years	1,2,3,4 years
Secondary	Predictors of disease progression	Evaluation of predictors of disease progression from baseline demographic and ocular characteristics	4 years

External Links

•   Project web page