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Toric Intraocular Lenses for Cataract Patients in the NHS

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04122651
Enrollment
168
Registered
2019-10-10
Start date
2019-10-14
Completion date
2020-08-31
Last updated
2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Cataract, Cornea

Brief summary

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

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.

Interventions

PROCEDURE'Off the shelf' toric lens

'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation

PROCEDURETailored Toric lens

Fully targeted toric intraocular lens correction for corneal astigmatism

Sponsors

City, University of London
CollaboratorOTHER
King's College London
CollaboratorOTHER
Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients will be randomised into one of two groups.

Intervention model description

Rayone Toric intraocular lens (for cataract surgery)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

1. Bilateral or unilateral cataracts requiring surgical intervention 2. Age over 18 years 3. Able to understand informed consent and the objectives of the trial 4. Not pregnant, not breast feeding 5. No previous eye surgery 6. Corneal astigmatism greater than 1.5 diopters in one eye.

Exclusion criteria

1. age-related macula degeneration 2. glaucoma 3. previous retinal vascular disorders 4. previous retinal detachment or tear 5. any neuro-ophthalmological condition 6. any inherited retinal disorder or pathology 7. previous strabismus surgery or record of amblyopia 8. previous TIA, CVA or other vaso-occlusive disease 9. already enrolled in another study

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuities6 monthsCorrected and uncorrected Logmar Visual Acuities
Refractive Error6 months

Secondary

MeasureTime frameDescription
Intraoperative and post operative complications0 day-6 months
Patient Satisfaction6 monthsPatient satisfaction scores using validated questionnaires

Contacts

Primary ContactKhayam Naderi, MBBS BSc MA
khayam.naderi@gstt.nhs.uk020 7188 7188

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026