Toric IOL vs Non-toric IOL With LRI for Corneal Astigmatism

Toric Intraocular Lens (IOL) Implantation Compared to Incisional Surgery to Correct Corneal Astigmatism as Part of Cataract Surgery - A Randomised Controlled Clinical Trial

The purpose of the study is to compare the astigmatism reducing effect of a toric intraocular lens (IOL) (model MX60T - Bausch & Lomb) with that of limbal relaxing incisional surgery combined with a non toric IOL (model MX60 - Bausch & Lomb) in patients with corneal astigmatism between 1.0 and 1.5 diopters and also the effect of cylinder reduction on patient's quality of vision.

Study Overview

• Status: Unknown
• Conditions: Corneal Astigmatism
• Intervention / Treatment: Device: Toric intraocular MX60T lens; Other: Standard MX60 plus corneal incisions

Detailed Description

This is a randomised controlled trial with intra-patient comparison (bilateral study) in which study patients will be randomized by a medical statistician to the implantation of the toric intraocular lens (IOL) (model MX60T, Bausch & Lomb) in one eye and the non-toric IOL model MX60 plus LRI in the fellow eye.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isaac John, PhD; Phone Number: 0044 193 272 2901; Email: Isaac.John@nhs.net
• Study Contact Backup: Name: Freda Gomes, MSc; Phone Number: 0044 193 272 6664; Email: Freda.Gomes@nhs.net

Study Locations

• United Kingdom
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • Recruiting
      • Dr Isaac John
      • Contact: Freda Gomes; Phone Number: 01932723534; Email: freda.gomes@nhs.net
      • Principal Investigator: Vinod Gangwani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bilateral cataract.
• 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:

• Ocular comorbidity (corneal scars, amblyopia, retina, or optic nerve disease) that may reduce postoperative CDVA
• Reduced zonular or capsular stability (e.g. Marfan syndrome, previous eye trauma)
• Irregular corneal astigmatism on Orbscan topography

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Toric intraocular MX60T lens; one eye will receive toric MX60T lens	Device: Toric intraocular MX60T lens; one eye will receive toric MX60T lens
Other: Standard MX60 plus corneal incisions; the other eye will receive standard MX60 lens with corneal incisions	Other: Standard MX60 plus corneal incisions; the other eye will receive standard MX60 lens with corneal incisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.	Astigmatism reduction will be evaluated with optical biometry, corneal topography	6 months and 12 months
Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL	Astigmatism reduction will be evaluated with manifest refraction, autorefraction	6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unaided visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.	Measurement of uncorrected visual acuity, monocular and binocular, will be done using a back-lit EDTRS chart placed at 4m. Although these assessments appear to have different units of measurements, but all the measurements will be in the same units of measure.	6 months and 12 months
Best-spectacle corrected visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.	Measurement of best-spectacle corrected visual acuity, monocular and binocular, will be done using a back-lit EDTRS chart placed at 4m.	6 months and 12 months
Quality of Vision	Quality of Vision will be evaluated with the QoV (Quality of Vision) 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).	6 months and 12 months
Visual disability	Visual disability will be evaluated with the 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.	6 months and 12 months
Overall satisfaction	Overall satisfaction will be evaluated with vision rating questionnaire. It will be obtained by asking patients to rate whether they were very satisfied, satisfied, neither satisfied nor unsatisfied, unsatisfied, or very unsatisfied.	6 months and 12 months
Dysphotopsia	Dysphotopsia will be evaluated with the 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."	6 months and 12 months

Collaborators and Investigators

• Sponsor: Ashford and St. Peter's Hospitals NHS Trust
• Collaborators: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Vinod Gangwani, MBBS FRCS, Ashford and St. Peter's Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: ASPH2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No