Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.
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|ClinicalTrials.gov Identifier: NCT02067429|
Recruitment Status : Unknown
Verified November 2014 by Christin Henein, Sussex Eye Hospital.
Recruitment status was: Recruiting
First Posted : February 20, 2014
Last Update Posted : December 2, 2014
This study will compare toric intra-ocular lens (IOL) with limbal relaxing incisions (LRI) in correcting astigmatism in patient undergoing standard cataract surgery.
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.
|Condition or disease||Intervention/treatment||Phase|
|Astigmatism Cataract||Procedure: Limbal Relaxing Incisions Device: Toric Intraocular Lens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Limbal Relaxing Incisions Versus Toric Intraocular Lens for Keratometric Astigmatism <2.5 Diopters in Patients Undergoing Cataract Surgery and Intraocular Lens Implantation.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2015|
Experimental: Toric Intraocular lens
Toric intraocular lens implantation during standard cataract surgery
Device: Toric Intraocular Lens
Experimental: Limbal Relaxing Incisions
Limbal relaxing incisions during standard cataract surgery
Procedure: Limbal Relaxing Incisions
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 1 months ]
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 3 months ]
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 6 months ]
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067429
|Contact: Deborah Horney||Deborah.Horney2@bsuh.nhs.uk|
|Sussex Eye Hospital||Recruiting|
|Brighton, United Kingdom, BN2 5BF|
|Contact: Deborah Horney Deborah.Horney2@bsuh.nhs.uk|
|Principal Investigator: Mayank Nanavaty, DO, MRCSEd, FRCOphth|
|Sub-Investigator: Christin Henein, MBBS, MRes, FRCOphth (part 1)|
|Sub-Investigator: Saul Rajak, MBBS, PhD, FRCOphth|