Condition category
Eye Diseases
Date applied
30/10/2009
Date assigned
15/12/2009
Last edited
19/05/2015
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

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/H0402/107

Study information

Scientific title

Comparison of glistenings in two hydrophobic acrylic intraocular lenses after cataract surgery in diabetics: a randomised controlled trial

Acronym

Study hypothesis

Hydrophobic acrylic intraocular lenses (IOL) account for the majority of the market in the UK. In some patients microvacuoles known as glistenings are seen to form in the IOL material in the first 2 years after surgery. These do not affect visual acuity after surgery, but could cause light scatter in the eye and glare. They are seen more commonly clinically in eyes with damaged blood aqueous barriers, such as in diabetes or uveitis.

Recently a new intraocular lens (AVS) which has a slightly higher water content (4% versus less than 1%) does not appear to develop glistenings. We plan to compare this IOL with a standard hydrophobic IOL in diabetic patients.

Ethics approval

St Thomas' Research Ethics Committee, 27/10/2009

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

Cataract

Intervention

AVS hydrophobic intraocular lens versus AcrySof® intraocular lens. Patients will be randomised to have routine cataract surgery to one eye with implantation of either the Santen or the AcrySof® lens. Randomisation will be via a remote computer based website. Surgery to the second eye will be performed within 6 weeks of the first operation by the same surgeon, with the other intraocular lens type.

Patients will be followed up for a total of 3 years.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Glistenings
2. Vision
Taken at 1, 3, 6, 12, 24 and 36 months.

Secondary outcome measures

1. Post-operative inflammation after cataract surgery and cellular deposition on the IOL surface
2. Objective optical quality and wave-front aberration
3. Contrast sensitivity
4. Diabetic retinopathy after cataract surgery
Taken at 1, 3, 6, 12, 24 and 36 months.

Overall trial start date

01/01/2010

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Bilateral cataracts requiring surgery
2. Diabetic
3. Aged 18 years or over, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Diabetic maculopathy

Recruitment start date

01/01/2010

Recruitment end date

01/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guys and St Thomas' Hospital NHS Foundation Trust (UK)

Sponsor details

c/o Karen Ignatian
London
SE1 7EH
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Charity

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

Advanced Vision Science (AVS) (UK) - providing intraocular 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

Publication citations

Additional files

Editorial Notes