The TRIAGE Study: Identifying Non-Responders to Glaucoma Eye Drops

Not Applicable

Completed

• Conditions: Glaucoma / ocular hypertension; Eye Diseases

• Registration Number: ISRCTN75888393
• Lead Sponsor: Cardiff University

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32139500/ (added 26/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-05
• Study Completion: 2019-07-31
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

RQ1: CLINICAL OBSERVATIONS, SITUATED INTERVIEWS AND SURVEY
Observations and Situated Interviews:
1. Aged 18 years or over
2. Attending an outpatient glaucoma clinic
3. Diagnosed with either glaucoma, ocular hypertension, normal tension glaucoma or pseudo-exfoliative glaucoma
4. Cognitively able to participate in the study
5. Able to speak English or have access to an interpreter.
6. Healthcare professionals will be eligible for inclusion if they are providing care to patients fitting the inclusion criteria within either of the primary research sites.

Survey:
1. Glaucoma specialist lead or nominated individual in a Welsh health board aside from Cwm Taf University Health Board and Cardiff and Vale University Health Board.

RQ2: SOP DEVELOPMENT AND FOCUS GROUPS ON STANDARD OPERATING PROCEDURE
SOP Development:
1. From one of the following stakeholder groups: nurses, doctors, optometrists, orthoptists, pharmacists, and glaucoma patients.
2. Aged 18 years or over
3. Must be cognitively able to participate
4. Able to speak English.

Focus Groups:
1. From one of the following stakeholder groups: glaucoma patient, lay carer of a glaucoma patient, doctor providing glaucoma care, pharmacist, optometrist, orthoptist, nurse providing glaucoma care, policy maker or NHS manager.
2. Aged 18 years or over
3. Must be cognitively able to participate
4. Able to speak English.

RQ3: COHORT FEASIBILITY STUDY
CMGC Cohort Feasibility Study:
1. Aged 18 years or over
2. Diagnosed with either primary open angle glaucoma, ocular hypertension, pseudo-exfoliative glaucoma, IOP equal to or greater than 21 mmHg, or normal tension glaucoma
3. Be on the point of being prescribed glaucoma eye drops.
4. Must be cognitively able to participate
5. Able to speak English or have access to an interpreter.

CMGC Staff Training:
1. Healthcare professionals are required to be working in one of the two ophthalmic research sites as either a doctor, nurse, orthoptist or optometrist.

RQ4: PATIENT / HEALTHCARE PROFESSIONAL INTERVIEWS AND OBSERVATION
Patient Interviews:
1. Adult patients aged 18 years or over
2. Diagnosed with either glaucoma, ocular hypertension, normal tension glaucoma or pseudo-exfoliative glaucoma
3. Cognitively able to participate in the study
4. Have either i) never participated in CMGC and whom are eye drop naïve, or ii) never participated in CMGC and who are established eye drop users, or iii) participated in CMGC and are up to 4 months post-CMGC.

Healthcare Professional Interviews:
1. Healthcare professional or member of the management team involved in the operation of the CMGC study.

Observation:
Either:
1. Glaucoma patient receiving the CMGC intervention (aged 18 years or over) OR
2. Healthcare professional or member of the clinical team involved in the operation of the CMGC study

Exclusion Criteria

RQ3: COHORT FEASIBILITY STUDY
CMGC Cohort Feasibility Study:
1. Ocular surgery in the last three months
2. Having a form of acute glaucoma
3. Already being prescribed and taking eye drops
4. Any other condition that may affect drop efficacy

Study & Design

• Study Type: Interventional
• Study Design: Not specified