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 measure
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 (if study stopped)
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
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)
Fight for Sight, Inc., 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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24427795
Publication citations
-
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.