Clinical trial NCT02067429: Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Astigmatism
Cataract
Lead sponsor: Sussex Eye Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Rayner Intraocular Lenses Limited
First posted: 2014-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Symptomatic cataract for which the patient desires surgery
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:

1. \<18 years of age
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.

Primary outcomes:
measure: Unaided distance LogMAR visual acuity (UDVA)
timeFrame: 1 months
measure: Unaided distance LogMAR visual acuity (UDVA)
timeFrame: 3 months
measure: Unaided distance LogMAR visual acuity (UDVA)
timeFrame: 6 months
measure: Unaided distance LogMAR visual acuity (UDVA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Sussex Eye Hospital
Study officials:
References: