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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Christin Henein, Sussex Eye Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02067429
First Posted: February 20, 2014
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rayner Intraocular Lenses Limited
Information provided by (Responsible Party):
Christin Henein, Sussex Eye Hospital
  Purpose

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 Intervention
Astigmatism Cataract Procedure: Limbal Relaxing Incisions Device: Toric Intraocular Lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.

Resource links provided by NLM:


Further study details as provided by Christin Henein, Sussex Eye Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: June 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Deborah Horney Deborah.Horney2@bsuh.nhs.uk

Locations
United Kingdom
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         
Sponsors and Collaborators
Christin Henein
Rayner Intraocular Lenses Limited
  More Information

Responsible Party: Christin Henein, Academic Foundation Doctor, Sussex Eye Hospital
ClinicalTrials.gov Identifier: NCT02067429     History of Changes
Other Study ID Numbers: RCT135670
First Submitted: February 17, 2014
First Posted: February 20, 2014
Last Update Posted: December 2, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors