Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr AJE Foss

ORCID ID

Contact details

Department of Ophthalmology
B Floor
South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 9249924 (44249)
alexander.foss@nuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192080944

Study information

Scientific title

Randomised controlled trial of reconstruction against secondary intention healing of defects of the medial canthus

Acronym

Study hypothesis

How do the results of formal reconstruction of defects of the medial canthus compare against healing by secondary intention, following tumour excision?

01/09/2015: Trial was abondoned in 1999 due to an inability to recruit participants as all patients wanted to be in the intervention group.

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

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

Surgery: Reconstruction of medial canthus

Intervention

Randomised controlled trial.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Snelen visual acuity, diplopia, patency of lacrimal system, lid mal-positions, features of corneal exposure, photographs with four expressions, quality of life assessment.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/02/1999

Overall trial end date

31/12/1999

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

60>, Caucasian, less than 1/3 of either upper or lower lid being involved, dimension of defect must measure less than 4x4 cm, the centre of the defect must be within 1.5 cm of the medial canthal tendon.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

17/02/1999

Recruitment end date

31/12/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Ophthalmology
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Nottingham University Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes