Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.

Cataract Clinical Trial

Official title:

Limbal Relaxing Incisions Versus Toric Intraocular Lens for Keratometric Astigmatism <2.5 Diopters in Patients Undergoing Cataract Surgery and Intraocular Lens Implantation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02067429
• Other study ID #: RCT135670
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2014
• Last updated: November 27, 2014
• Start date: June 2014

Study information

• Verified date: November 2014
• Source: Sussex Eye Hospital
• Contact: Deborah Horney
• Email: Deborah.Horney2[@]bsuh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Procedure:
• Limbal Relaxing Incisions

Device:
• Toric Intraocular Lens

Locations

Country	Name	City	State
United Kingdom	Sussex Eye Hospital	Brighton

Sponsors (2)

Lead Sponsor	Collaborator
Christin Henein	Rayner Intraocular Lenses Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unaided distance LogMAR visual acuity (UDVA)		1 months	No
Primary	Unaided distance LogMAR visual acuity (UDVA)		3 months	No
Primary	Unaided distance LogMAR visual acuity (UDVA)		6 months	No
Primary	Unaided distance LogMAR visual acuity (UDVA)		12 months	No