Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
13/12/2013
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 Edmondo Borasio

ORCID ID

Contact details

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
edmondoborasio@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0141187716

Study information

Scientific title

Acronym

Study hypothesis

To assess the feasibility of a randomised controlled trial to assess the accuracy of a formula (BESSt© formula) recently developed to calculate the power of the lens to implant in the eye during cataract surgery in eyes which have previously undergone laser refractive surgery.

Ethics approval

Not provided at time of registration

Study design

Centrally randomised controlled trial - 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. BESSt©
2. Hollday

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Patient recruitment rates
2. Rates of loss to follow up in treatment arm
3. Difference between target and achieved manifest refraction following phaci in the two groups

Secondary outcome measures

Proportion of eyes with outcomes within +0.25/0.5/0.75/1/1.50/2.0D from the target refraction using the different formulae

Overall trial start date

01/08/2006

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any eye undergoing phaco following keratorefractive surgery
2. Any intraocular lens (IOL) model
3. Any type of keratorefractive surgery
4. Patients under the care of Ms Ficker or Mr Stevens

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30 eyes

Participant exclusion criteria

1. Children
2. Corneal scarring or opacity
3. Severe dry eyes or ptosis
4. Complicated phaco, presence of a rhexis tear if IOL is implanted in bag

Recruitment start date

01/08/2006

Recruitment end date

01/05/2007

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/17137976

Publication citations

  1. Results

    Borasio E, Stevens J, Smith GT, Estimation of true corneal power after keratorefractive surgery in eyes requiring cataract surgery: BESSt formula., J Cataract Refract Surg, 2006, 32, 12, 2004-2014, doi: 10.1016/j.jcrs.2006.08.037.

Additional files

Editorial Notes