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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
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.
Secondary ID [1] 282800 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 289571 0
High corneal astigmatism 289572 0
Condition category
Condition code
Eye 289900 289900 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287484 0
Treatment: Devices
Intervention code [2] 287490 0
Treatment: Surgery
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289960 0
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.
Timepoint [1] 289960 0
Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
Primary outcome [2] 289961 0
Uncorrected Distance Visual Acuity (UCDVA)
Timepoint [2] 289961 0
Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
Primary outcome [3] 289962 0
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.
Timepoint [3] 289962 0
Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
Secondary outcome [1] 303663 0
Postoperative Refractive Astigmatism
This is assessed with manifest refraction. Refraction is performed subjectively to obtain the refractive astigmatism value.
Timepoint [1] 303663 0
At 1-2 weeks, 1 month and 3 months after intervention commencement
Secondary outcome [2] 303664 0
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.
Timepoint [2] 303664 0
Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
Secondary outcome [3] 303665 0
Reduction in absolute cylinder
This is assessed with manifest refraction. Refraction is performed subjectively to obtain the refractive value.
Timepoint [3] 303665 0
Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
Secondary outcome [4] 303666 0
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.
Timepoint [4] 303666 0
Baseline, and at 1-2 week, 1 month and 3 months after intervention commencement
Secondary outcome [5] 303667 0
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.
Timepoint [5] 303667 0
Day of intervention commencement
Secondary outcome [6] 303668 0
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.
Timepoint [6] 303668 0
Baseline, Day of intervention commencement, and at 1-2 days, 1-2 week, 1 month and 3 months after intervention commencement
Secondary outcome [7] 303669 0
Postoperative Best Corrected Distance Visual Acuity (BCDVA) by visit window
Timepoint [7] 303669 0
At 1-2 week, 1 month and 3 months after intervention commencement

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
29/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5171 0
New Zealand
State/province [1] 5171 0
Auckland

Funding & Sponsors
Funding source category [1] 287577 0
Commercial sector/Industry
Name [1] 287577 0
Bausch + Lomb Incorporated
Country [1] 287577 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bausch + Lomb Incorporated
Address
1400, N. Goodman Street, Rochester, NY 14609
Country
United States of America
Secondary sponsor category [1] 286327 0
None
Name [1] 286327 0
Address [1] 286327 0
Country [1] 286327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289552 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 289552 0
Ethics committee country [1] 289552 0
New Zealand
Date submitted for ethics approval [1] 289552 0
Approval date [1] 289552 0
27/06/2013
Ethics approval number [1] 289552 0
13/NTB/48

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41294 0
Dr Dean Corbett
Address 41294 0
Auckland Eye
8 St. Marks Road, Remuera 1050, Auckland, New Zealand
Country 41294 0
New Zealand
Phone 41294 0
+64-95292480
Fax 41294 0
+64-95292481
Email 41294 0
dlcorbett@xtra.co.nz
Contact person for public queries
Name 41295 0
May Mendoza
Address 41295 0
Auckland Eye
8 St. Marks Road, Remuera 1050, Auckland, New Zealand
Country 41295 0
New Zealand
Phone 41295 0
+64-95292480
Fax 41295 0
+64-95292481
Email 41295 0
research@aucklandeye.co.nz
Contact person for scientific queries
Name 41296 0
Omid Khodai
Address 41296 0
Bausch + Lomb
30 Enterprise, Suite 450, Aliso Viejo, CA 92656
Country 41296 0
United States of America
Phone 41296 0
+1 949 521 7894
Fax 41296 0
Email 41296 0
omid.khodai@bausch.com

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.