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

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Medical Conditions
  • Cataract
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN93583656

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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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

15 Dec 2009

Date updated in source

19 May 2015