Toric Intraocular Lenses for Cataract Patients in the NHS
Primary Purpose
Cataract, Astigmatism, Cornea
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
'Off the shelf' toric lens
Tailored Toric lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Arm
Control Arm
Arm Description
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.
The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.
Outcomes
Primary Outcome Measures
Visual Acuities
Corrected and uncorrected Logmar Visual Acuities
Refractive Error
Secondary Outcome Measures
Intraoperative and post operative complications
Patient Satisfaction
Patient satisfaction scores using validated questionnaires
Full Information
NCT ID
NCT04122651
First Posted
October 8, 2019
Last Updated
October 9, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
City, University of London, King's College London
1. Study Identification
Unique Protocol Identification Number
NCT04122651
Brief Title
Toric Intraocular Lenses for Cataract Patients in the NHS
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
City, University of London, King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Astigmatism, Cornea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Rayone Toric intraocular lens (for cataract surgery)
Masking
Participant
Masking Description
Patients will be randomised into one of two groups.
Allocation
Randomized
Enrollment
168 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.
Intervention Type
Procedure
Intervention Name(s)
'Off the shelf' toric lens
Intervention Description
'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation
Intervention Type
Procedure
Intervention Name(s)
Tailored Toric lens
Intervention Description
Fully targeted toric intraocular lens correction for corneal astigmatism
Primary Outcome Measure Information:
Title
Visual Acuities
Description
Corrected and uncorrected Logmar Visual Acuities
Time Frame
6 months
Title
Refractive Error
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Intraoperative and post operative complications
Time Frame
0 day-6 months
Title
Patient Satisfaction
Description
Patient satisfaction scores using validated questionnaires
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khayam Naderi, MBBS BSc MA
Phone
020 7188 7188
Ext
84331
Email
khayam.naderi@gstt.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Toric Intraocular Lenses for Cataract Patients in the NHS
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