Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001319460p
Ethics application status
Not yet submitted
Date submitted
15/09/2016
Date registered
21/09/2016
Date last updated
21/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Quality of vision of patients implanted with intraocular lens after cataract surgery
Scientific title
Quality of vision of patients implanted with intraocular lens after cataract surgery
Secondary ID [1] 290160 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of Vision after cataract removal and intraocular lens implantation 300281 0
Condition category
Condition code
Eye 300148 300148 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a patient reported outcome study using a validated questionnaire as instrument. Patients have had cataract removal and intraocular lens implantation (these include any commercially available models used at the study recruitment sites) at least 3 months prior. Patients will be asked to observe their vision quality for 1 week and answer questions that provided to them by the questionnaire.
Intervention code [1] 295924 0
Not applicable
Comparator / control treatment
The same questionnaire will be used on randomly selected patients with intraocular lenses of various types and models.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299640 0
The Quality of Vision (QoV) questionnaire is a validated Patient Reported Outcome (PRO) instrument. It consists of 10 questions on different types of visual disturbances (e.g. blurring, haloes, double vision, etc.). Each item has 3 corresponding questions regarding the Frequency, Severity and Bothersome, resulting in a 30-item questionnaire.
Timepoint [1] 299640 0
The instrument will be presented and explained to the subjects at minimum of 3 months after cataract removal and intraocular lens implantation surgery. They will then be send home with the questionnaire. They will be asked to return to the clinic 1 week after and the questionnaire will be administered at the clinic by the study staff for 3 times. First for the left eye, second for the right eye and third for binocular experience. After this visit, it is considered that patient completed the study.
Primary outcome [2] 299664 0
The QoV measures positive dysphotopsia but not negative dysphotopsia which is pertinent to any IOL study. A separate part of questionnaire composed of 3 questions will be used to measure negative dysphotopsia." These 3 questions have been designed specifically for this study.
Timepoint [2] 299664 0
The instrument will be presented and explained to the subjects at minimum of 3 months after cataract removal and intraocular lens implantation surgery. They will then be send home with the questionnaire. They will be asked to return to the clinic 1 week after and the questionnaire will be administered at the clinic by the study staff for 3 times. First for the left eye, second for the right eye and third for binocular experience. After this visit, it is considered that patient completed the study.
Secondary outcome [1] 327722 0
None
Timepoint [1] 327722 0
None

Eligibility
Key inclusion criteria
1. Must have had cataract removal and intraocular lens implantation at least 3 months prior.
2. Must be willing to answer the questionnaire
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject who, in the clinical judgment of the investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8230 0
New Zealand
State/province [1] 8230 0
Auckland
Country [2] 8231 0
Philippines
State/province [2] 8231 0
Manila

Funding & Sponsors
Funding source category [1] 294527 0
Commercial sector/Industry
Name [1] 294527 0
ClarVista Medical, Inc.
Country [1] 294527 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ClarVista Medical, Inc.
Address
26800 ALISO VIEJO PARKWAY, SUITE 120
ALISO VIEJO, CA 92656
Country
United States of America
Secondary sponsor category [1] 293390 0
None
Name [1] 293390 0
Address [1] 293390 0
Country [1] 293390 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295960 0
HDEC
Ethics committee address [1] 295960 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295960 0
New Zealand
Date submitted for ethics approval [1] 295960 0
23/09/2016
Approval date [1] 295960 0
Ethics approval number [1] 295960 0

Summary
Brief summary
Cataract surgery with Intraocular lens implantation is one of the most common surgical procedures. In the past several years, the development of new technology IOL has added optical design features to help improve patient visual functions. There have been associated visual disturbances with some of these design features hence it is important to characterize the patient’s quality of vision after cataract surgery and IOL implantation.
In this study, we evaluate vision quality of subjects with different IOL systems using a validated quality of vision questionnaire* as the main outcome measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69070 0
Dr Dean Corbett
Address 69070 0
Auckland Eye
8 St. Marks Rd.
Remuera 1050
Country 69070 0
New Zealand
Phone 69070 0
+64 9 529 2480
Fax 69070 0
Email 69070 0
[email protected]
Contact person for public queries
Name 69071 0
Dr Melvin Sarayba
Address 69071 0
CLARVISTA MEDICAL, INCORPORATED
26800 ALISO VIEJO PARKWAY, SUITE 120
ALISO VIEJO, CA 92656
Country 69071 0
United States of America
Phone 69071 0
+1 949 916-5412
Fax 69071 0
Email 69071 0
[email protected]
Contact person for scientific queries
Name 69072 0
Dr Melvin Sarayba
Address 69072 0
CLARVISTA MEDICAL, INCORPORATED
26800 ALISO VIEJO PARKWAY, SUITE 120
ALISO VIEJO, CA 92656
Country 69072 0
United States of America
Phone 69072 0
+1 949 916-5412
Fax 69072 0
Email 69072 0
[email protected]

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
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