Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000798662
Ethics application status
Approved
Date submitted
7/07/2014
Date registered
28/07/2014
Date last updated
28/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Retrospective/prospective Clinical Study of AcrySof (Registered Trademark) IQ ReSTOR (Registered Trademark) +2.5 D Multifocal Toric Intraocular Lenses, which will collect information about the safety and effectiveness (how the lens works) from participants who have had cataract surgery and been implanted with these intraocular lenses
Scientific title
The primary objective of the study is to characterize the safety
(adverse events) and effectiveness (residual cylinder and visual acuity) of the ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2- SV25T5).
Secondary ID [1] 284934 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cataract 292413 0
presbyopia 292414 0
corneal astigmatism 292415 0
Condition category
Condition code
Eye 292727 292727 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
A: The AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intraocular Lens is implanted during cataract surgery to replace the cataractous lens
B: Once as the AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intraocular Lens stays in the eye for life of the patient
Intervention code [1] 289761 0
Treatment: Devices
Comparator / control treatment
There is no treatment or no control group as this is a retrospective study collecting information from participants previously implanted with these lenses
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292574 0
Effeciveness (residual cylinder including Mean % reduction in cylinder, proportion of subjects with manifest refraction cylinder <0.5D, proportion of subjects with manifest refraction clylinder <1D)
Subjective and objective (autofractor) refraction
Timepoint [1] 292574 0
3-14 months postoperative
Primary outcome [2] 292728 0
Effectiveness (visual acuity (LogMAR) including Mean uncorrected near, intermediate and distance visual acuity)
Objective measuremenst of visual acuity (LogMAR) using phoropter or trial frames
Timepoint [2] 292728 0
3 months to 14 months
Primary outcome [3] 292729 0
Safety (including adverse events)

Medical Records and an examination of the eye and discussion with patient. Tools and tests used are Visual Acuity, Manifest Refraction, Adverse Event Assessment, Secondary Surgical Interventions, Slit Lamp Exam, Dilated Fundus Examination, Device Deficiency Assessment. Examples of adverse events may be
*Halos (circles) or lines around light sources in nighttime conditions
*Decreased contrast sensitivity in low light conditions (ex. Driving at night or in poor visibility conditions)
*Rotation of the lens from the original placement on the eye can decrease astigmatic correction
Timepoint [3] 292729 0
3 months to 14 months
Secondary outcome [1] 309258 0
Nil
Timepoint [1] 309258 0
Nil

Eligibility
Key inclusion criteria
must sign an informed consent and be willing to come in for a visit at least 3 mths and not more than 14 mths after IOL implantation with the AcrySof IQ ReSTOR +2.5D multifocal toric IOL;must be implanted with the corrected lens based on preoperative corneal astigmatism; must complete a visit within 10 days after IOL implantation; successful capsular bag implantation with no surgical complications;
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
IOL implanted prior to the AcrySof (Registered Trademark) IQ ReSTOR (Registered Trademark) +2.5 D Multifocal Toric IOL; Ocular or intraocular infection or inflammation at the same time of the preoperative visit;
Any ocular surgery (eg. LASIK, corneal transplant, limbal relaxing incision, etc.) or intraocular laser procedure (SLT, ALT, etc.) at or prior to the surgical visit; Any conditions affecting the cornea (eg. Corneal dystrophy, severe dry eye) at the preoperative visit; Retinal conditions (e.g degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit; Known history of type 1 or 2 diabetes for more than 5 years; Any ocular or systemic co-morbidity at the preoperative visit; Pregnant at the preoperative visit or at the time of the Post-operative visit
;preoperative corneal astigmatism <0.5D; participation in another clinical study at the preoperative visit or at the time of the final study visit

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/07/2014
Actual
21/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 289562 0
Commercial sector/Industry
Name [1] 289562 0
Alcon Research
Country [1] 289562 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Alcon Laboratories (Australia) Pty Ltd
Address
10/25 Frenchs Forest Road Frenchs Forest NSW 2086
Country
Australia
Secondary sponsor category [1] 288244 0
None
Name [1] 288244 0
Address [1] 288244 0
Country [1] 288244 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291301 0
Bellberry HREC
Ethics committee address [1] 291301 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 291301 0
Australia
Date submitted for ethics approval [1] 291301 0
23/05/2014
Approval date [1] 291301 0
11/07/2014
Ethics approval number [1] 291301 0
2014-06-323

Summary
Brief summary
This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation. The study is unmasked with no control group, no randomization and will include approximately 4 sites.

The primary objective of the study is to characterize the safety (adverse events) and effectiveness (residual cylinder and visual acuity) of the AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2-SV25T5)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49758 0
Dr Michael Lawless
Address 49758 0
Vision Eye Institute Level 3, 270 Victoria Ave, Chatswood, NSW 2067, Australia
Country 49758 0
Australia
Phone 49758 0
+61 2 9424 9999
Fax 49758 0
Email 49758 0
[email protected]
Contact person for public queries
Name 49759 0
Miss Claire Perrott
Address 49759 0
Alcon Laboratories Pty Ltd
10 / 25 Frenchs Forest Road East Frenchs Forest NSW 2086 AUSTRALIA
Country 49759 0
Australia
Phone 49759 0
+61 0450692667
Fax 49759 0
Email 49759 0
[email protected]
Contact person for scientific queries
Name 49760 0
Miss Claire Perrott
Address 49760 0
Alcon Laboratories Pty Ltd
10 / 25 Frenchs Forest Road East Frenchs Forest NSW 2086 AUSTRALIA
Country 49760 0
Australia
Phone 49760 0
+61 0450692667
Fax 49760 0
Email 49760 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.