Trial record 15 of 133 for:    ASTIGMATISM

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Sussex Eye Hospital
Sponsor:
Collaborator:
Rayner Intraocular Lenses Limited
Information provided by (Responsible Party):
Christin Henein, Sussex Eye Hospital
ClinicalTrials.gov Identifier:
NCT02067429
First received: February 17, 2014
Last updated: February 18, 2014
Last verified: February 2014
  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 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.

Resource links provided by NLM:


Further study details as provided by Sussex Eye Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067429

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

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

No publications provided

Responsible Party: Christin Henein, Academic Foundation Doctor, Sussex Eye Hospital
ClinicalTrials.gov Identifier: NCT02067429     History of Changes
Other Study ID Numbers: RCT135670
Study First Received: February 17, 2014
Last Updated: February 18, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 29, 2014