Evaluation of reading vision after cataract surgery and lens implantation

ISRCTN	ISRCTN44390838
DOI	https://doi.org/10.1186/ISRCTN44390838
Protocol serial number	N/A
Sponsor	Guy's and St Thomas' NHS Foundation Trust (UK)
Funders	Guy's and St Thomas' NHS Foundation Trust (UK) - Cataract and IOL Research Fund, Fight for Sight (UK), Bausch and Lomb (USA) - providing the lenses

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr David Spalton
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparison of near vision performance of the Crystalens® HD against the Technis® Aspheric Intra-Ocular Lens: a randomised controlled trial
Study objectives	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(s)	Guys' Hospital Research Ethics Committee, London, 08/10/2009, ref: 09/H804/82
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Visual acuity All primary and seconadry outcomes will be assessed at 1, 3, 6, 12 and 24 months.
Key secondary outcome measure(s)	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.
Completion date	20/11/2011

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	20/11/2009
Date of final enrolment	20/11/2011

St Thomas' Hospital

London
SE1 7EH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes