Toric Intraocular Lenses for Cataract Patients in the NHS
October 9, 2019 updated by: Guy's and St Thomas' NHS Foundation Trust
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.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Arm
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.
|
'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation
|
|
Active Comparator: Control Arm
The patient will receive a toric intraocular lens individually tailored to and ordered for each patients' precise degree of corneal astigmatism.
|
Fully targeted toric intraocular lens correction for corneal astigmatism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Acuities
Time Frame: 6 months
|
Corrected and uncorrected Logmar Visual Acuities
|
6 months
|
|
Refractive Error
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative and post operative complications
Time Frame: 0 day-6 months
|
0 day-6 months
|
|
|
Patient Satisfaction
Time Frame: 6 months
|
Patient satisfaction scores using validated questionnaires
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 14, 2019
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
October 8, 2019
First Submitted That Met QC Criteria
October 9, 2019
First Posted (Actual)
October 10, 2019
Study Record Updates
Last Update Posted (Actual)
October 10, 2019
Last Update Submitted That Met QC Criteria
October 9, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 265865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.