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Trial registered on ANZCTR
Registration number
ACTRN12613000770763
Ethics application status
Approved
Date submitted
9/07/2013
Date registered
10/07/2013
Date last updated
16/05/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A Multi-Center, Open-Label, Post-market, Investigation of Clinical Outcomes in Eyes implanted with enVista Registered Trademark Toric Intraocular Lens
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Scientific title
A Multi-Center, Open-Label, Post-market, Investigation of Clinical Outcomes in patients implanted with Bausch + Lomb enVista Registered Trademark Toric Intraocular Lens (IOL) in one or both eyes as part of standard cataract surgery for the reduction of the effects of preoperative corneal astigmatism on postoperative refraction.
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Secondary ID [1]
282800
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NIL
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Universal Trial Number (UTN)
NIL
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cataract
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High corneal astigmatism
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Condition category
Condition code
Eye
289900
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Each study participant will be observed for a duration of 3 months after intervention commencement in this study, for the reduction of the effects of preoperative corneal astigmatism on postoperative refraction after cataract surgery with implantation of enVista Toric Intraocular Lens (IOL) in one or both eyes.
The enVista Toric Intraocular Lens is a single piece posterior chamber intraocular lens developed to replace the human crystalline lens in adult patients in whom the cataractous human lens has been removed during cataract surgery.
The duration of the full cataract surgery is approximately 30 minutes of which the implantation procedure of enVista Intraocular lens is approximately 5 minutes.
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Intervention code [1]
287484
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Treatment: Devices
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Intervention code [2]
287490
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Treatment: Surgery
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Dioptric change in cylinder (absolute preoperative corneal cylinder minus absolute residual postoperative refractive astigmatism, with the postoperative astigmatism converted to the corneal plane)
This is assessed with Keratometry and manifest refraction. The values of preoperative and postoperative astigmatism will be compared to identify the Dioptric change in astigmatism.
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Assessment method [1]
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Timepoint [1]
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Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
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Primary outcome [2]
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Uncorrected Distance Visual Acuity (UCDVA)
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Assessment method [2]
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Timepoint [2]
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Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
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Primary outcome [3]
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Manifest Refraction Spherical Equivalent (MRSE) accuracy to target.
This is assessed with manifest refraction. Refraction is performed subjectively to obtain the refractive value. It will be compared with the value of the target refraction per IOL power calculation.
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Assessment method [3]
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Timepoint [3]
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Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
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Secondary outcome [1]
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Postoperative Refractive Astigmatism
This is assessed with manifest refraction. Refraction is performed subjectively to obtain the refractive astigmatism value.
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Assessment method [1]
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Timepoint [1]
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At 1-2 weeks, 1 month and 3 months after intervention commencement
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Secondary outcome [2]
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Postoperative Refractive Astigmatism accuracy to target
This is assessed with manifest refraction. Refraction is performed subjectively to obtain the refractive value. It will be compared with the value of the target refraction per IOL power calculation.
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Assessment method [2]
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Timepoint [2]
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Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
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Secondary outcome [3]
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Reduction in absolute cylinder
This is assessed with manifest refraction. Refraction is performed subjectively to obtain the refractive value.
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Assessment method [3]
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Timepoint [3]
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Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
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Secondary outcome [4]
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Spectacle Independence
This is assessed with Patient Questionnaire.
The name of the Questionnaire is Bausch + Lomb Study #846 Patient Questionnaire.
There are questions which will require participants to provide answer to how often they wear eyeglasses, type of corrective eyeglasses, frequency of wearing eyeglasses etc.
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Assessment method [4]
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Timepoint [4]
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Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
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Secondary outcome [5]
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Summary of Intraoperative Complications
Examples of known intraoperative complications include capsular tear, wound leak, corneal edema, IOL optic decentration.
They are assessed during cataract surgery, under the microscope of the phacoemulsification machine.
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Assessment method [5]
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Timepoint [5]
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Day of intervention commencement
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Secondary outcome [6]
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Summary of Ocular Adverse Events (AEs)
Examples of Ocular Adverse Events include anterior uveitis, IOL opacities, raised IOP, retinal detachment, macular edema.
They are assessed with Slit Lamp biomicroscopy, funduscopy or Optical Coherence Tomography.
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Assessment method [6]
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Timepoint [6]
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Baseline, Day of intervention commencement, and at 1-2 days, 1-2 week, 1 month and 3 months after intervention commencement
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Secondary outcome [7]
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Postoperative Best Corrected Distance Visual Acuity (BCDVA) by visit window
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Assessment method [7]
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Timepoint [7]
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At 1-2 week, 1 month and 3 months after intervention commencement
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Eligibility
Key inclusion criteria
Subjects must have a best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 (or equivalent) after toric IOL implantation, have a target postoperative manifest refraction spherical equivalent (MRSE) projected to be within +/-0.37D and postoperative residual astigmatism of less than or equal to 0.50D as reflected by the Toric calculator
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Subjects with ocular comorbidities (eg, diabetic retinopathy, macular degeneration, chronic inflammations, corneal opacities, dystrophies, or diseases, amblyopia etc) which could be expected to reduce potential Best corrected Distance Visual Acuity (BCDVA) to 20/32 or worse during study participation, irregular astigmatism and history of corneal (including refractive) or intraocular surgery in the enrolled eye
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Not applicable
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Preoperative, operative and postoperative data collected in the electronic database will be analysed by Bausch + Lomb.
Descriptive statistics will be used to summarize the data. Continuous variables will be summarized by mean, standard deviation, median, minimum, and maximum. Categorical variables will be summarized by frequency and percentage
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
29/07/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Bausch + Lomb Incorporated
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Address [1]
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1400, N. Goodman Street, Rochester, NY 14609
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Bausch + Lomb Incorporated
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Address
1400, N. Goodman Street, Rochester, NY 14609
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Health and Disability Ethics Committees (HDEC)
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Ethics committee address [1]
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Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6011
New Zealand
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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Approval date [1]
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27/06/2013
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Ethics approval number [1]
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13/NTB/48
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Summary
Brief summary
The primary objective of this investigation is to collect and evaluate clinical outcomes in patients implanted with Bausch + Lomb enVista Toric Intraocular Lens (IOL) in one or two eyes as part of standard cataract surgery for the reduction of the effects of preoperative corneal astigmatism on postoperative refraction.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Dean Corbett
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Address
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Auckland Eye
8 St. Marks Road, Remuera 1050, Auckland, New Zealand
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Country
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New Zealand
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Phone
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+64-95292480
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Fax
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+64-95292481
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Email
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[email protected]
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Contact person for public queries
Name
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Ms May Mendoza
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Address
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Auckland Eye
8 St. Marks Road, Remuera 1050, Auckland, New Zealand
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Country
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New Zealand
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Phone
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+64-95292480
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Fax
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+64-95292481
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Omid Khodai
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Address
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Bausch + Lomb
30 Enterprise, Suite 450, Aliso Viejo, CA 92656
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Country
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United States of America
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Phone
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+1 949 521 7894
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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