Toric Intraocular Lenses for Cataract Patients in the NHS

Not Applicable

• Conditions: Cataract; Cornea; Astigmatism
• Interventions: Procedure: 'Off the shelf' toric lens; Procedure: Tailored Toric lens

• Registration Number: NCT04122651
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-09
• Last Update Submitted: 2019-10-09
• Study First Posted: 2019-10-10
• Last Update Posted: 2019-10-10
• Study Start: 2019-10-14
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	'Off the shelf' toric lens	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.
Control Arm	Tailored Toric lens	The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.

Primary Outcome Measures

Name	Time	Method
Visual Acuities	6 months	Corrected and uncorrected Logmar Visual Acuities
Refractive Error	6 months

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	6 months	Patient satisfaction scores using validated questionnaires
Intraoperative and post operative complications	0 day-6 months