Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.
NCT ID: NCT02067429
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2014-06-30
Brief Summary
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Astigmatism is unequal curvature of the eye; the eye is oval rather than spherical. Uncorrected astigmatism of greater than approximately 0.75 diopters (D) can cause visual blurring, ghosting of images or halos. Over 20% of patients undergoing cataract surgery have astigmatism which is likely to have been corrected by spectacles.
Cataract surgery involves the replacement of the natural opacifying crystalline lens with a clear artificial plastic intra-ocular lens (IOL). The lens power can be selected to correct the patient's glasses prescription. The most widely used IOLs only correct glasses at one distance i.e. either near or distance. Residual astigmatism after cataract surgery will need glasses for correction which is undesirable for many patients.
Limbal relaxing incisions (LRI) are circumferential partial thickness cuts to the clear window of the eye (cornea) during surgery. These LRIs can correct corneal astigmatism and have no additional risk of complications.
Alternatively, toric IOLs are available which correct astigmatism inside the eye. They have been available for routine use in the last few years; technology has markedly improved and the lenses have become cheaper.
Studies have suggested toric IOLs provide better vision after cataract surgery than the regular IOLs. Toric IOL are widely used in the private practice and increasingly in the National Health Service (NHS). LRIs are cost effective for treating astigmatism however their predictability is believed to be lower than toric IOLs. As there are no randomised controlled trials comparing the outcomes between LRIs and toric IOLs. This research will address this gap in knowledge and accordingly from this research future practice will be able to provide treatment to patients with information about the best outcomes.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Toric Intraocular lens
Toric intraocular lens implantation during standard cataract surgery
Toric Intraocular Lens
Limbal Relaxing Incisions
Limbal relaxing incisions during standard cataract surgery
Limbal Relaxing Incisions
Interventions
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Limbal Relaxing Incisions
Toric Intraocular Lens
Eligibility Criteria
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Inclusion Criteria
2. Corneal astigmatism of greater than or equal to 0.75 D and lesser than or equal to 2.5D.
3. No significant ophthalmic co-morbidity which would affect the postoperative visual outcomes.
Exclusion Criteria
2. Significant ophthalmic comorbidity detrimental to final visual outcomes
3. Not competent to give consent
4. Concurrent use of ocular medications including lubricants
5. Unable to attend follow ups at 1, 3, 6 and 12 months.
18 Years
ALL
No
Sponsors
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Rayner Intraocular Lenses Limited
INDUSTRY
Christin Henein
OTHER_GOV
Responsible Party
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Christin Henein
Academic Foundation Doctor
Locations
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Sussex Eye Hospital
Brighton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCT135670
Identifier Type: -
Identifier Source: org_study_id