ISRCTN ISRCTN93782578
DOI https://doi.org/10.1186/ISRCTN93782578
Protocol serial number N0199136008
Sponsor Department of Health
Funder Royal Berkshire and Battle Hospitals NHS Trust (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
15/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Mr Martin Leyland
Scientific

Eye Department
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Study information

Primary study designInterventional
Study designRandomised prospective single-centre surgical study
Secondary study designRandomised controlled trial
Scientific titleQuality of Vision with the Acrysof Natural Intraocular Lens
Study objectivesDoes the new Acrysof Natural Intraocular Lens, which reduces the amount of damaging blue light reaching the retina, have any significant effect on visual outcome or colour vision post cataract surgery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Cataract
InterventionRandomised, prospective single centre surgical study to determine whether the new Acrysof Natural Intraocular Lens has any significant effect on visual outcome or colour vision post cataract surgery
Intervention typeProcedure/Surgery
Primary outcome measure(s)

1. Colour vision
2. Visual acuity
3. Contrast sensitivity

Key secondary outcome measure(s)

Not provided at time of registration

Completion date28/02/2006

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration40
Key inclusion criteria20 patients and 20 controls having standard cataract surgery
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/12/2003
Date of final enrolment28/02/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan