Toric IOL vs Non-toric IOL With LRI for Corneal Astigmatism
NCT ID: NCT03633851
Last Updated: 2018-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-10-03
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
NCT06839898
Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery
NCT06277349
Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens
NCT01075542
Low Cylinder Toric
NCT00732030
Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism
NCT03538964
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
During pre-operative examination, the patient will undergo:
* An ophthalmic examination including slit lamp biomicroscopy and retinal examination;
* Uncorrected and best-corrected visual acuity (UCVA and BCVA): monocular and binocular;
* Optical biometry with IOLMaster (Carl Zeiss Meditec);
* Orbscan corneal topography (Bausch and Lomb Orbscan IIz Corneal Analysis System);
* Quality of Vision (QoV) questionnaire score). It is a validated, Rasch-adjusted questionnaire in which patients are asked to rate 10 dysphotopsia items illustrated by standard photographs, scoring each item (0, 1, 2, 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total).
* Catquest 9-SF cataract visual disability questionnaire. It is a Rasch-adjusted cataract visual disability questionnaire that asks patients to rate difficulty with a range of vision-related daily activities.
The appropriate cylinder power of the MX60T toric-IOL as well of its axis of implantation will be calculated with the calculator provided by the manufacturer Bausch + Lomb (https://trulign.toriccalculator.com).
Subsequently, the patient will undergo cataract surgery with IOL implantation under local anaesthesia.
The temporal self-sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag will be performed as standard procedure.
According to randomisation, each patient will receive the implantation of the MX60T toric-IOL in one eye and the MX60 non-toric IOL combined with limbal relaxing incisions (LRI) in the fellow eye.
The eye that will receive the toric-IOL will have the horizontal meridian marked preoperatively at the limbus in the sitting position with a blue marking pen and insulin syringe.
The IOL will be implanted via injector into the capsular bag using the manufacturers' recommended IOL loading and injection technique.
The toric-IOL will be rotated in the capsular bag so that the axis markers on the IOL will be aligned to the limbal markings (planned axis). Then, the viscoelastic substance will be aspirated thoroughly from the eye. Final refinement of axis position of the IOL will be undertaken after removal of viscoelastic material from the capsular bag to ensure that irrigation/aspiration of viscoelastic does not move the lens off axis.
The fellow eye will receive a temporal or an on-axis incision with limbal relaxing incision with a 600µm single-use steel blade combined with the MX60 non-toric IOL (http://www.lricalculator.com).
The interval between the first and second eye surgery will be recorded. The location and length of the LRIs will be made after calculation according to the Donnenfeld nomogram (www.lricalculator.com).
After one hour postoperatively, a photo of the toric-IOL in retroillumination will be taken to evaluate if IOL is on axis.
At six months and twelve months after the surgery performed in the second eye, patients will undergo assessement of:
* autorefraction;
* unaided and best-spectacle corrected visual acuity (monocular and binocular),
* optical biometry;
* corneal topography;
* photo of the toric-IOL in retroillumination (to evaluate if IOL is on axis);
* Catquest 9-SF cataract visual disability questionnaire;
* Quality of Vision (QoV) questionnaire score;
* Overall satisfaction with vision rating questionnaire (only at 6 months and 12 months). It will be obtained by asking patients to rate whether they were very satisfied, satisfied, neither satisfied nor unsatisfied, unsatisfied, or very unsatisfied.
* Dysphotopsia questionnaire. They are 4 questions regarding dysphotopsia symptoms: "Since your surgery, have you noticed any" halo, glare or dazzle, unwanted images, or shadows? Patients were asked to respond by indicating whether they had not experienced these symptoms at all ("none") or found them "barely noticeable," "annoying," or "debilitating."
Statistical analysis will be performed using SPSS for Macintosh software (version 20.0, International Business Machines Corp.). Normality distribution will be tested with the Shapiro-Wilk test; data will be considered normal if the p value is less than 0.05. The central tendency and statistical dispersion of each parameter will be recorded as the mean and standard deviation (SD) for normal data and as the median and interquartile difference for nonparametric data. The coordinates of keratometric cylinders and the centroids will be calculated according to the Alpins method. Double-angle polar plots will be used to display the astigmatism analysis (Excel 2011 for Macintosh, Microsoft Corp.).
The Student t test for paired samples and the Wilcoxon signed-rank test will be used for normal and nonparametric data, respectively, to compare the 2 related samples.
A statistically significant difference will be defined as a p value less than 0.05.
Any adverse event will be recorded.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Toric intraocular MX60T lens
one eye will receive toric MX60T lens
Toric intraocular MX60T lens
one eye will receive toric MX60T lens
Standard MX60 plus corneal incisions
the other eye will receive standard MX60 lens with corneal incisions
Standard MX60 plus corneal incisions
the other eye will receive standard MX60 lens with corneal incisions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Toric intraocular MX60T lens
one eye will receive toric MX60T lens
Standard MX60 plus corneal incisions
the other eye will receive standard MX60 lens with corneal incisions
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 21 and older.
* Written informed consent to sequential bilateral surgery and participation in the study.
* Preoperative pupil size greater than or equal to 5.0 mm in the study eye.
* IOL power as predicted by biometry ranging from 6.0 D to 30.0 D in both eyes.
* Regular corneal astigmatism according to Orbscan topography.
* Postoperative corneal astigmatism between 0.90 D and 1.40 D in both eyes, as predicted by the Bausch + Lomb Toric Calculator (https://envista.toriccalculator.com).
Exclusion Criteria
* Reduced zonular or capsular stability (e.g. Marfan syndrome, previous eye trauma)
* Irregular corneal astigmatism on Orbscan topography
21 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch & Lomb Incorporated
INDUSTRY
Ashford and St. Peter's Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vinod Gangwani, MBBS FRCS
Role: PRINCIPAL_INVESTIGATOR
Ashford and St. Peter's Hospitals NHS Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dr Isaac John
Chertsey, Surrey, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASPH2016-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.