Evaluation of cataract surgery and lens implantation in diabetics | Not Recruiting
Evaluation of cataract surgery and lens implantation in diabetics

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Cataract
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN93583656
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • 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.
Phase
Sorry, this information is not available
Study Design
Randomised controlled trial
Study Type
Interventional
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
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.
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
40
Participant Inclusion Criteria
  • 1. Bilateral cataracts requiring surgery
  • 2. Diabetic
  • 3. Aged 18 years or over, either sex
Participant Exclusion Criteria
  • Diabetic maculopathy
Trial Location(s)
Guy's and St Thomas NHS Foundation Trust, of St Thomas' Hospital
London
SE1 7EH
Trial Contact(s)
Primary Trial Contact
Mr David Spalton
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Comparison of glistenings in two hydrophobic acrylic intraocular lenses after cataract surgery in diabetics: a randomised controlled trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Fight for Sight (UK)
  • Advanced Vision Science (AVS) (UK) - providing intraocular lenses
Other Study ID Numbers
09/H0402/107
Sponsor(s)
Guys and St Thomas' Hospital NHS Foundation Trust (UK)
Key Dates

Recruitment Start Date

01 Jan 2010

Recruitment End Date

01 Jan 2013

Trial Start Date

01 Jan 2010

Trial End Date

01 Jan 2013

Date Assigned

15 Dec 2009

Last Updated

19 May 2015