Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
29/09/2011
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 Scott Hau

ORCID ID

Contact details

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
+44
Scott.Hau@moorfields.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0141187713

Study information

Scientific title

Acronym

Study hypothesis

To compare two techniques of cataract surgery: conventional phacoemulsification versus the newer Aqualase technique especially looking at the rate of corneal endothelial cell loss and complications rate seen with each technique.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Eye Diseases: Cataract

Intervention

1. Standard phacoemulsification
2. Aqualase

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Percentage of cell loss

Secondary outcome measures

1. Coefficient of variation and hexagonality of cell sizes at 3 months
2. Per-and-postoperative complications

Overall trial start date

20/09/2006

Overall trial end date

20/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Routine cataracts less than or equal to grade 3 determined by Oxford grading scale

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30 patients - 30 eyes in each group

Participant exclusion criteria

1. Other ocular or systemic co-morbidity factors
2. Patients with an axial length greater than 26.5mm
3. Combined procedures
4. Cataracts greater than grade 3

Recruitment start date

20/09/2006

Recruitment end date

20/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

Moorfields Eye Hospital NHS Foundation Trust (UK) NHS R&D Support Funding

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

No publication intended as of 29/09/2011

Publication citations

Additional files

Editorial Notes