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

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ClinicalTrials.gov Identifier: NCT03633851
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Ashford and St. Peter's Hospitals NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Corneal Astigmatism Device: Toric intraocular MX60T lens Other: Standard MX60 plus corneal incisions Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Toric Intraocular Lens (IOL) Implantation Compared to Incisional Surgery to Correct Corneal Astigmatism as Part of Cataract Surgery - A Randomised Controlled Clinical Trial
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

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

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




Primary Outcome Measures :
  1. Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions. [ Time Frame: 6 months and 12 months ]
    Astigmatism reduction will be evaluated with optical biometry, corneal topography

  2. Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL [ Time Frame: 6 months and 12 months ]
    Astigmatism reduction will be evaluated with manifest refraction, autorefraction


Secondary Outcome Measures :
  1. Unaided visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions. [ Time Frame: 6 months and 12 months ]
    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.

  2. Best-spectacle corrected visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions. [ Time Frame: 6 months and 12 months ]
    Measurement of best-spectacle corrected visual acuity, monocular and binocular, will be done using a back-lit EDTRS chart placed at 4m.

  3. Quality of Vision [ Time Frame: 6 months and 12 months ]
    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).

  4. Visual disability [ Time Frame: 6 months and 12 months ]
    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.

  5. Overall satisfaction [ Time Frame: 6 months and 12 months ]
    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. Dysphotopsia [ Time Frame: 6 months and 12 months ]
    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."



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633851


Contacts
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Contact: Isaac John, PhD 0044 193 272 2901 Isaac.John@nhs.net
Contact: Freda Gomes, MSc 0044 193 272 6664 Freda.Gomes@nhs.net

Locations
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United Kingdom
Dr Isaac John Recruiting
Chertsey, Surrey, United Kingdom, KT16 0PZ
Contact: Freda Gomes    01932723534    freda.gomes@nhs.net   
Principal Investigator: Vinod Gangwani         
Sponsors and Collaborators
Ashford and St. Peter's Hospitals NHS Trust
Bausch & Lomb Incorporated
Investigators
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Principal Investigator: Vinod Gangwani, MBBS FRCS Ashford and St. Peter's Hospitals NHS Trust

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Responsible Party: Ashford and St. Peter's Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03633851     History of Changes
Other Study ID Numbers: ASPH2016-01
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases