Condition category
Eye Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heather Waterman

ORCID ID

Contact details

School of Nursing
Midwifery and Health Visiting
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 5334
Heather.waterman@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI14-20

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study was to test the key hypothesis that: Co-management of care in a peripheral ophthalmic clinic will improve the efficiency and cost-effectiveness of, and patient satisfaction with, day-care management of cataract surgery. Three objectives were identified:
1.To assess the value of introducing a trained ophthalmic nurse into the care of patients with cataract attending the peripheral clinic
2. To ascertain the best site for pre-operative assessment (peripheral or main hospital)
3. To evaluate the post-operative management of patients including possible role changes in the multi-disciplinary team

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cataract

Intervention

Patients were randomly allocated to receive either the experimental (introduction of a trained ophthalmic nurse) or control (standard) model of care. N = 31 - intervention, N = 32 - control

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

For both groups, visual outcomes (acuity and function), anxiety and depression, costs to patients and the NHS, and patient satisfaction were the outcome measures selected. Observational data relating to development of staff roles were also collected. All data were collected by an independent researcher.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1995

Overall trial end date

10/07/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with cataracts

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

63

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/07/1995

Recruitment end date

10/07/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Nursing, Midwifery and Health Visiting
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

1. 1999 protocol in http://www.ncbi.nlm.nih.gov/pubmed/10354248
2. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10396388

Publication citations

  1. Protocol

    Rose K, Waterman H, McLeod D, Tullo A, Planning and managing research into day-surgery for cataract., J Adv Nurs, 1999, 29, 6, 1514-1519.

  2. Results

    Rose K, Waterman H, Toon L, McLeod D, Tullo A, Management of day-surgery patients with cataract attending a peripheral ophthalmic clinic., Eye (Lond), 1999, 13 ( Pt 1), 71-75, doi: 10.1038/eye.1999.14.

Additional files

Editorial Notes