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.
1 other identifier
interventional
168
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 10, 2019
October 1, 2019
10 months
October 8, 2019
October 9, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Visual Acuities
Corrected and uncorrected Logmar Visual Acuities
6 months
Refractive Error
6 months
Secondary Outcomes (2)
Intraoperative and post operative complications
0 day-6 months
Patient Satisfaction
6 months
Study Arms (2)
Experimental Arm
EXPERIMENTALPatients 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
ACTIVE COMPARATORThe patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.
Interventions
'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
Eligibility Criteria
You may qualify if:
- Bilateral or unilateral cataracts requiring surgical intervention
- Age over 18 years
- Able to understand informed consent and the objectives of the trial
- Not pregnant, not breast feeding
- No previous eye surgery
- Corneal astigmatism greater than 1.5 diopters in one eye.
You may not qualify if:
- age-related macula degeneration
- glaucoma
- previous retinal vascular disorders
- previous retinal detachment or tear
- any neuro-ophthalmological condition
- any inherited retinal disorder or pathology
- previous strabismus surgery or record of amblyopia
- previous TIA, CVA or other vaso-occlusive disease
- already enrolled in another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- City, University of Londoncollaborator
- King's College Londoncollaborator
Related Publications (1)
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.
PMID: 39073343DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients will be randomised into one of two groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 10, 2019
Study Start
October 14, 2019
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
October 10, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share