Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.
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.
Procedure: Limbal Relaxing Incisions
Device: Toric Intraocular Lens
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Limbal Relaxing Incisions Versus Toric Intraocular Lens for Keratometric Astigmatism <2.5 Diopters in Patients Undergoing Cataract Surgery and Intraocular Lens Implantation.|
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 1 months ] [ Designated as safety issue: No ]
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Unaided distance LogMAR visual acuity (UDVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02067429
|Contact: Deborah Horney||Deborah.Horney2@bsuh.nhs.uk|
|Sussex Eye Hospital||Not yet 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|