Condition category
Eye Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
11/05/2009
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

Mr Laurence Whitefield

ORCID ID

Contact details

Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0533171160

Study information

Scientific title

Acronym

Study hypothesis

To determine any potential difference in effect on corneal endothelial cell loss between two methods for removing cataracts: aqualase and phacoemulsification.

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

Condition

Eye Diseases: Cataract

Intervention

1. Aqualase
2. Phacoemulsification

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Corneal endothelial cell counts and coefficient of variation of cell size

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2005

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who have requested removal of soft to moderately dense cataracts.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Ocular co-morbidity resulting in anterior segment pathology
2. Previous intra-ocular inflammation
3. Raised intra-ocular pressure
4. Previous intra-ocular surgery

Recruitment start date

01/10/2005

Recruitment end date

01/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Queen Mary's Sidcup 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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18499007

Publication citations

  1. Results

    Barsam A, Chandra A, Bunce C, Whitefield LA, Prospective randomized controlled trial to compare the effect on the macula of AquaLase liquefaction and ultrasound phacoemulsification cataract surgery., J Cataract Refract Surg, 2008, 34, 6, 991-995, doi: 10.1016/j.jcrs.2008.02.017.

Additional files

Editorial Notes