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BlindnessNCT00403143

Do Blue-Blocking Lenses Block Blue Colour From Our Lives?

A study testing cataract surgery in people with Blindness, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To measure colour vision in patients with a blue light filtering lens implant in one eye and non-tinted implant in the other eye (and compared this group with a control group with bilateral non-tinted implants) and to determine whether blue light filtering lenses limit colour vision Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Blindness
What is being tested?
cataract surgery
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2006to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients who have had uncomplicated cataract surgery in one eye and have a cataract in the other eye
  • patients who are over 18 years of age
  • patients who are fully able to independently give consent to have surgery

Who cannot join

  • patients who have any other ocular co-morbidity that may account for reduction in vision in either eye (as this may confound the condition)
  • patients who are colour blind
  • patients who suffered previous post-operative complications
  • patients under 18

Trial locations and contacts

1 site in 1 country.

Amynah Goawalla, BSc, MBBS MRCOphth contact

020 963 ext. 7130

amynahgoawalla@nwlh.nhs.uk

United Kingdom1 site, 1 recruiting
  • North West London Hospitals NHS Trust

    London, NW10 7NS

    Alan Warnes, PhD, 020 8869 ext. 2011, alan.warnes@nwlh.nhs.uk

    Iva Hauptmannova, BSc MA, 020 8869 ext. 5286, iva.hauptmannova@nwlh.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Do Blue-Blocking Lenses Block Colour From Our Lives? A Randomised Controlled Study Measuring Colour Vision Using the Gold Standard Colour Vision Test (an Anomaloscope)in Patients With Blue Light Filtering Intraocular Lenses (Tinted Yellow) and Comparing This With Patients Inserted With Clear, Non Blue Light Filtering Intraocular Lenses During Cataract Surgery

To measure colour vision in patients with a blue light filtering lens implant in one eye and non-tinted implant in the other eye (and compared this group with a control group with bilateral non-tinted implants) and to determine whether blue light filtering lenses limit colour vision

Read the detailed description

As we all age, the natural lens inside our eyes becomes denser, hazy and more yellow in colour. In other words, cataracts develop. In order to enable clear vision again, cataract surgery is performed. This involves removing the natural lens from the eye and replacing it with a synthetic lens implant inside the eye. Cataract surgery with insertion of a lens implant was first done in 1948 but didn't become routine until the early 1980s. Around this time, awareness about the harmful effects of UV light were raised and by 1986, lens implants routinely had a UV filter incorporated into them.1 As early as 1992, a study examining patients who had had a high occupational exposure to blue and visible light, concluded that there is a positive association between long term exposure to visible light and age related wear and tear change at the back of the eye, termed age related macular degeneration (AMD).2 This theory was supported by several studies which have reported an increased rate of progression of AMD in patients after cataract surgery with a clear lens implant (It is known that clear lens implants transmit more blue light to the back of the eye compared with the natural aging lens).3 Laboratory studies in 2000 showed that blue light causes damage to aging retinal cells (the nerve cells at the back of the eye which are important in enabling us to see), more so than green light or white light.4 Experimental studies with rats also showed that exposure to blue light was 30 times more damaging to retinal cells compared with yellow light.5 A further laboratory study in 2004 confirmed that by protecting aging retinal cells with a blue light filtering lens, damage caused by blue light is prevented.6 Yellow tinted, blue light filtering lens implants have been in production since 1991, first by Hoya in Tokyo and now by Alcon as well. Alcon produce the Acrysof Natural lens implant which has been designed to mimic the 53 year old natural lens and which received FDA and CE approval in 2003. To date, over 2 million of these lenses have been implanted in patients world wide.7 Although these lens implants are sometimes used in patients having cataract surgery in the UK, this is not yet routine. One of the concerns about them is whether or not they limit colour vision in any way. There have been some studies examining this and so far, none of them have found a statistically significant difference in the colour vision between patients with non-tinted lens implants and blue-filtering lens implants.8,9,10 However, none of the studies thus far, have employed colour vision testing with an anomaloscope (which is considered to be the gold standard colour vision test).11 In addition, none of them have taken into account the level of capsular opacification (the capsule is a cling film bag-like structure that supports the lens implant inside the eye and can over a period of time, become thickened and hazy following cataract surgery) and the level of macular pigment (yellow pigment which we have on the centre part of the back of our eyes which is thought to contribute towards filtering blue light) in patients' eyes.

Age related macular degeneration is already the commonest cause of blindness in the UK. It is a growing problem, particularly with our aging population and increasing levels of ambient light which we are exposed to in our daily lives. Although the evidence is strongly in favour of filtering blue light and the need for protective measures against AMD are pressing, we need to be satisfied that there are no adverse effects of blocking blue from our lives.

Conditions
Blindness
Being tested
cataract surgery
Keywords
intraocular lens, colour vision, blue-light filtering
Medical subject headings
Blindness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cataract surgeryProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To objectively determine whether colour vision is reduced with a blue-light filtering

  2. intraocular lens compared with a colourless intraocular implant in cataract surgery

Secondary outcomes (2)
  1. To determine whether patients subjectively are able to tell whether they have been

  2. implanted with yellow tinted intraocular lens during their cataract surgery or colourless one

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2006 (estimated)
  2. Study startOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00403143
Sponsor's protocol ID
06/Opa/23
Status last verified
May 2007
First submitted
22 Nov 2006
Last updated
14 May 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing cataract surgery in people with Blindness, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amynah Goawalla, BSc, MBBS MRCOphth (020 963 ext. 7130, amynahgoawalla@nwlh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To objectively determine whether colour vision is reduced with a blue-light filtering. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2007.

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