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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation
Fully targeted toric intraocular lens correction for corneal astigmatism
Visual Acuities
Corrected and uncorrected Logmar Visual Acuities
Time frame: 6 months
Refractive Error
Time frame: 6 months
Intraoperative and post operative complications
Time frame: 0 day-6 months
Patient Satisfaction
Patient satisfaction scores using validated questionnaires
Time frame: 6 months
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