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| Name | Class |
|---|---|
| City, University of London | OTHER |
| King's College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | 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. |
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| Control Arm | Active Comparator | The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'Off the shelf' toric lens | Procedure | 'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuities | Corrected and uncorrected Logmar Visual Acuities | 6 months |
| Refractive Error | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative and post operative complications | 0 day-6 months | |
| Patient Satisfaction | Patient satisfaction scores using validated questionnaires | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khayam Naderi, MBBS BSc MA | Contact | 020 7188 7188 | 84331 | khayam.naderi@gstt.nhs.uk |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39073343 | Derived | Naderi K, Jameel A, Chow I, Hull C, O'Brart D. Effects of axis-flip of the refractive cylinder on vision and patient-reported outcome measures after toric intraocular lens implantation. J Cataract Refract Surg. 2024 Dec 1;50(12):1230-1235. doi: 10.1097/j.jcrs.0000000000001530. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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Rayone Toric intraocular lens (for cataract surgery)
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Patients will be randomised into one of two groups.
| Tailored Toric lens | Procedure | Fully targeted toric intraocular lens correction for corneal astigmatism |
|