Do blue-blocking lenses block blue colour from our lives? A randomised controlled study measuring colour vision using the gold standard colour vision test (an anomaloscope) in patients with blue filtering intraocular lenses (tinted yellow)

ISRCTN	ISRCTN21290113
DOI	https://doi.org/10.1186/ISRCTN21290113
ClinicalTrials.gov number	NCT00403143
Secondary identifying numbers	N0515186315

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 27/11/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Amynah Goawalla
Scientific

Department of Ophthalmology
North West London Hospitals NHS Trust
Central Middlesex Hospital
Acton Lane
Park Royal
London
NW10 7NS
United Kingdom

Phone	+44 (0)20 8963 7158
Email	amynahgoawalla@gmail.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Do blue-blocking lenses block blue colour from our lives? A randomised controlled study measuring colour vision using the gold standard colour vision test (an anomaloscope) in patients with blue filtering intraocular lenses (tinted yellow)
Study objectives	To measure colour vision in patients with a blue light filtering lens implant in one eye and a non-tinted implant in the other eye (and compare this group with a control group with bilateral non-tinted implants) and to determine whether blue light filtering lenses limit colour vision in any way.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Eye Diseases: Visual sense
Intervention	Blue light filtering lens implant in one eye vs non-tinted implant in the other eye. A paired t-test will be used to analyse the results.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2006
Completion date	30/10/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	We aim to recruit 40 participants in total, 20 in each group
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2006
Date of final enrolment	30/10/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Ophthalmology

London
NW10 7NS
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North West London Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

27/11/2019: The trial was stopped in 2007 and no results were or will be published.
25/11/2019: ClinicalTrials.gov number added. No publications found. Verifying results with principal investigator
18/05/2017: No publications found in PubMed, verifying study status with principal investigator.