Condition category
Eye Diseases
Date applied
09/10/2009
Date assigned
26/10/2009
Last edited
04/08/2014
Prospective/Retrospective
Prospectively 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 David Spalton

ORCID ID

Contact details

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of near vision performance of the Crystalens® HD against the Technis® Aspheric Intra-Ocular Lens: a randomised controlled trial

Acronym

Study hypothesis

The Crystalens® HD is a new accommodative intra-ocular lens (IOL) which may potentially improve reading and near vision compared to standard monofocal lenses. The performance of this IOL will be compared to a standard monofocal IOL.

Ethics approval

Guys' Hospital Research Ethics Committee, London, 08/10/2009, ref: 09/H804/82

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Cataracts/near vision/intra-ocular lens

Intervention

Crystalens® HD vs standard monofocal IOL

Participants and outcome assessors will be blinded to participant allocation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Visual acuity

All primary and seconadry outcomes will be assessed at 1, 3, 6, 12 and 24 months.

Secondary outcome measures

1. Refraction
2. Objective optical image quality
3. Posterior capsule opacification
4. Measurement of IOL position
5. Contrast sensitivity
6. Objective and subjective measure of accommodation
7. Pupil size

All primary and seconadry outcomes will be assessed at 1, 3, 6, 12 and 24 months.

Overall trial start date

20/11/2009

Overall trial end date

20/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 18 years or older
2. Documented diagnosis of bilateral cataract requiring surgery
3. Potential visual acuity of 6/12 or better in both eyes
4. Patients who require an IOL in the range of 10-30 dioptres
5. Corneal astigmatism less than/equal to 1.0 dioptres after cataract surgery
6. Patients willing and able to provide informed consent and able to attend follow-up appointments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 (40 per group)

Participant exclusion criteria

1. Any coexisting ocular disease
2. Treatment with any ocular medication apart from artificial tear drops
3. Patients who are not fluent in English
4. Females of childbearing potential who are currently pregnant or breastfeeding

Recruitment start date

20/11/2009

Recruitment end date

20/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust (UK)

Sponsor details

c/o Karen Ignatian
R&D Department
2nd Floor
Conybeare House
Great Maze pond
London
SE1 9RT
United Kingdom

Sponsor type

Government

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Government

Funder name

Guy's and St Thomas' NHS Foundation Trust (UK) - Cataract and IOL Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fight for Sight (UK)

Alternative name(s)

FFS

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

Bausch and Lomb (USA) - providing the lenses

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24427795

Publication citations

  1. Results

    Dhital A, Spalton DJ, Gala KB, Comparison of near vision, intraocular lens movement, and depth of focus with accommodating and monofocal intraocular lenses., J Cataract Refract Surg, 2013, 39, 12, 1872-1878.

Additional files

Editorial Notes