Condition category
Eye Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof David B Henson


Contact details

REH Central Manchester & Manchester Children's University Hospitals
Manchester Royal Eye Hospital
Oxford Road
M13 9WH
United Kingdom
+44 0161 276 5507

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Adherence to therapy for patients with glaucoma or ocular hypertension


Study hypothesis

Current hypothesis as of 03/04/2008:
An individualised programme of care can improve adherence to therapy in newly treated cases of glaucoma or ocular hypertension

Previous hypothesis:
To establish the effect of enhanced nursing input to the persistency of therapy in newly treated cases of glaucoma and ocular hypertension.

Please note that the trial title was "The impact of enhanced nursing input on persistency of therapy in newly treated cases of glaucoma and ocular hypertension" until April 2008.

Ethics approval

Central Manchester Local Research Ethics Committee, 20/12/2004, amendment approved on 15/06/2005

Study design

Two-arm pilot randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.


Eye Diseases: Glaucoma


Added April 2008:

This pilot study has three parts.

Part 1: A Cochrane Systematic Review entitled, ‘Interventions for improving adherence to ocular hypotensive therapy’. Protocol for the Cochrane review published on:

Part 2: A cross-sectional study to collect baseline data entitled, ‘Factors associated with poor adherence to ocular hypotensive therapy’. Data will be collected via observation and interview from the outpatient clinic of the host organisation for patients diagnosed with glaucoma or ocular hypertension. This will include:
2.1 Observation of clinical practice in relation to verbal and written information regarding the use of eye drops and follow-up care, adherence to therapy advice and eye drop training.
2.2 Face to face interviews with patients to establish their knowledge of glaucoma, daily eye care management and problems associated with managing eye drops. Adherence to therapy will also be measured.

Part 3: A two-arm randomised controlled trial entitled ‘the impact of an individualised programme of care on persistence of and adherence to therapy in newly treated cases of glaucoma or ocular hypertension’. Stratification will take place on the basis of the type of clinic patients attend.
In arm 1 (non-intervention arm) patients will continue to receive the information, advice and training they would normally be given at the host organisation.
In arm 2 (intervention arm), patients will, in addition, undergo an assessment by a research nurse that takes into account factors such as other medical conditions, additional medications, independence with daily living activities, potential problems managing an eye drop regime and beliefs about medications etc.
Patients will receive a detailed explanation of the importance of therapy adherence, training on eye-drop instillation techniques and handouts giving further information about glaucoma or ocular hypertension. An individualised programme of care will be developed for each patient; this will include a series of follow-up contacts to ensure that the patient is managing their eye-drops and that any issues regarding adherence are dealt with promptly. All included patients will continue to follow the normal treatment protocols of the host organisation.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Persistency of treatment during the first year of therapy will be the main outcome measure. Persistency will be measured by comparing the number of doses dispensed and the number prescribed, taking into account that UK prescriptions are valid for 28 days.

Secondary outcome measures

Added April 2008:
Adherence to therapy, illness perceptions, beliefs about medicines and patient enablement. Secondary outcomes will be measured via validated questionnaires during patient interviews at the end of the study.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Added April 2008:
Patients newly prescribed ocular hypotensive eye drops with a diagnosis of open angle glaucoma, normal tension glaucoma, pseudo-exfoliation glaucoma, pigment dispersion glaucoma or ocular hypertension.

Participant type


Age group




Target number of participants

120 - 60 patients in each arm.

Participant exclusion criteria

Added April 2008:
Patients unable to give informed consent or patients already prescribed a complicated drop regime for another eye condition.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

REH Central Manchester & Manchester Children's University Hospitals
M13 9WH
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type

Hospital/treatment centre

Funder name

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/04/2017: No publications found in PubMed, verifying study status with principal investigator