NCT04122651

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cataract
• Astigmatism
• Cornea

Interventions

Type	Name	Description
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
PROCEDURE	Tailored Toric lens	Fully targeted toric intraocular lens correction for corneal astigmatism

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2019-10-10
• Last updated: 2019-10-10