NCT02067429

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1.5 years

First QC Date

February 17, 2014

Last Update Submit

November 27, 2014

Conditions

AstigmatismCataract

Outcome Measures

Primary Outcomes (4)

  • Unaided distance LogMAR visual acuity (UDVA)

    1 months

  • Unaided distance LogMAR visual acuity (UDVA)

    3 months

  • Unaided distance LogMAR visual acuity (UDVA)

    6 months

  • Unaided distance LogMAR visual acuity (UDVA)

    12 months

Study Arms (2)

Toric Intraocular lens

EXPERIMENTAL

Toric intraocular lens implantation during standard cataract surgery

Device: Toric Intraocular Lens

Limbal Relaxing Incisions

EXPERIMENTAL

Limbal relaxing incisions during standard cataract surgery

Procedure: Limbal Relaxing Incisions

Interventions

Limbal Relaxing IncisionsPROCEDURE
Limbal Relaxing Incisions
Toric Intraocular LensDEVICE
Toric Intraocular lens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic cataract for which the patient desires surgery
  • Corneal astigmatism of greater than or equal to 0.75 D and lesser than or equal to 2.5D.
  • No significant ophthalmic co-morbidity which would affect the postoperative visual outcomes.

You may not qualify if:

  • \<18 years of age
  • Significant ophthalmic comorbidity detrimental to final visual outcomes
  • Not competent to give consent
  • Concurrent use of ocular medications including lubricants
  • Unable to attend follow ups at 1, 3, 6 and 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sussex Eye Hospital

Brighton, BN2 5BF, United Kingdom

RECRUITING

MeSH Terms

Conditions

AstigmatismCataract

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLens Diseases

Central Study Contacts

Deborah Horney

CONTACT

Deborah.Horney2@bsuh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Academic Foundation Doctor

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 20, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

GB(1)