Toric Intraocular Lenses for Cataract Patients in the NHS

Study Overview
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Brief Summary
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To assess visual performance, refractive outcome, and patient satisfaction with the use of off the shelf toric lenses, with a set cylindrical correction of 2.00 or 4.00 diopters, and combined limbal relaxing incisions and/or off-axis intraocular lens rotation, compared to fully targeted toric intraocular lens correction.

Detailed Description
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The aim of this study is to evaluate a simplified, more cost-effective procedure for the use of toric intraocular lenses, with a focus on suitability for NHS cataract surgery. This study will involve the use of standard, off-the-shelf toric lenses rather than having them specifically tailored and ordered for each individual patient. Eligible participants (>1.25 D of corneal astigmatism) will be randomised, receiving a toric IOL with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, or a toric IOL individually tailored to and ordered for each patients' precise degree of corneal astigmatism. With the off the shelf toric IOL group the correction of the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient. The clinical outcome will then be measured and compared between the 2 groups. Independent safety monitoring will be performed.

Official Title
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Randomised, Controlled Study Comparing Use of Off the Shelf Toric Lenses, With Set Cylindrical Corrections (2.00D or 4.00D) and Combined Limbal Relaxing Incisions and/or Off-axis Lens Rotation, With Fully Targeted Toric Lens Correction.

Conditions
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Cornea, Cataract, Astigmatism

Intervention / Treatment
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* Procedure: 'Off the shelf' toric lens
* Procedure: Tailored Toric lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral or unilateral cataracts requiring surgical intervention Age over 18 years Able to understand informed consent and the objectives of the trial Not pregnant, not breast feeding No previous eye surgery Corneal astigmatism greater than 1.5 diopters in one eye. Exclusion Criteria: age-related macula degeneration glaucoma previous retinal vascular disorders previous retinal detachment or tear any neuro-ophthalmological condition any inherited retinal disorder or pathology previous strabismus surgery or record of amblyopia previous TIA, CVA or other vaso-occlusive disease already enrolled in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Rayone Toric intraocular lens (for cataract surgery)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Patients will be receiving a toric intraocular lens with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, and the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient. | Procedure: 'Off the shelf' toric lens<br>* 'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation<br>|
| Active Comparator: Control Arm<br>The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism. | Procedure: Tailored Toric lens<br>* Fully targeted toric intraocular lens correction for corneal astigmatism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuities | Corrected and uncorrected Logmar Visual Acuities | 6 months | 
| Refractive Error |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative and post operative complications |  | 0 day-6 months | 
| Patient Satisfaction | Patient satisfaction scores using validated questionnaires | 6 months |