Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.
Primary Purpose
Astigmatism, Cataract
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Limbal Relaxing Incisions
Toric Intraocular Lens
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- <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.
Sites / Locations
- Sussex Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Toric Intraocular lens
Limbal Relaxing Incisions
Arm Description
Toric intraocular lens implantation during standard cataract surgery
Limbal relaxing incisions during standard cataract surgery
Outcomes
Primary Outcome Measures
Unaided distance LogMAR visual acuity (UDVA)
Unaided distance LogMAR visual acuity (UDVA)
Unaided distance LogMAR visual acuity (UDVA)
Unaided distance LogMAR visual acuity (UDVA)
Secondary Outcome Measures
Full Information
NCT ID
NCT02067429
First Posted
February 17, 2014
Last Updated
November 27, 2014
Sponsor
Christin Henein
Collaborators
Rayner Intraocular Lenses Limited
1. Study Identification
Unique Protocol Identification Number
NCT02067429
Brief Title
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
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christin Henein
Collaborators
Rayner Intraocular Lenses Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toric Intraocular lens
Arm Type
Experimental
Arm Description
Toric intraocular lens implantation during standard cataract surgery
Arm Title
Limbal Relaxing Incisions
Arm Type
Experimental
Arm Description
Limbal relaxing incisions during standard cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Limbal Relaxing Incisions
Intervention Type
Device
Intervention Name(s)
Toric Intraocular Lens
Primary Outcome Measure Information:
Title
Unaided distance LogMAR visual acuity (UDVA)
Time Frame
1 months
Title
Unaided distance LogMAR visual acuity (UDVA)
Time Frame
3 months
Title
Unaided distance LogMAR visual acuity (UDVA)
Time Frame
6 months
Title
Unaided distance LogMAR visual acuity (UDVA)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
<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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Horney
Email
Deborah.Horney2@bsuh.nhs.uk
Facility Information:
Facility Name
Sussex Eye Hospital
City
Brighton
ZIP/Postal Code
BN2 5BF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Horney
Email
Deborah.Horney2@bsuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Mayank Nanavaty, DO, MRCSEd, FRCOphth
First Name & Middle Initial & Last Name & Degree
Christin Henein, MBBS, MRes, FRCOphth (part 1)
First Name & Middle Initial & Last Name & Degree
Saul Rajak, MBBS, PhD, FRCOphth
12. IPD Sharing Statement
Learn more about this trial
Limbal Relaxing Incision Versus Toric Intraocular Lens for Corneal Astigmatism During Cataract Surgery.
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