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Trial registered on ANZCTR


Registration number
ACTRN12611000443998
Ethics application status
Approved
Date submitted
11/04/2011
Date registered
29/04/2011
Date last updated
14/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the LenSx Laser System for Performing Anterior Capsulotomy, Phacofragmentation, and Corneal Arc Cuts/Incisions in Patients Undergoing Cataract Surgery for Removal of the Crystalline Lens
Scientific title
Evaluation of the LenSx Laser System for Performing Anterior Capsulotomy, Phacofragmentation, and Corneal Arc Cuts/Incisions in Patients Undergoing Cataract Surgery for Removal of the Crystalline Lens
Secondary ID [1] 259975 0
CPT-002m
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 265603 0
Condition category
Condition code
Eye 265748 265748 0 0
Diseases / disorders of the eye
Surgery 265749 265749 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this evaluation is to observe the performance of the Femtosecond Cataract Laser (LenSx Alcon) by assessing the performance of the following applications; laser created anterior capsulotomy, phacofragmentation, and/or corneal incisions, as well as to compare standard visual outcomes and commercial experience between laser and traditional manual cataract surgery procedures.

The laser procedure is assisting the removal of cataracts. Cataracts cause visual loss. Previous studies have shown that removing the cataract and implanting a new intraocular lens rehabilitate the patient's vision and may increase the patient’s quality of life.

The LenSx (Registered Trademark) Laser works by creating incisions through tightly focused femtosecond laser pulses that cut tissue with micron-scale precision. Further laser pulses are able to create the capsule and break up the existing or natural lens. The Laser replaces a combination of equipment including a blade to create the manual incisions, a needle to help open the capsule which then allows for the lens/cataract to be removed by the use with an external phaco emulsification unit.

In this study each patient will undergo each available application in order to fully assess the impact on safety and accuracy that the LenSx may provide in comparison to the manual (control) technique.

The duration of the Femtosecond laser is approximately 3 minutes. The subsequent removal of the lens and replacement by the new artifical lens commonly takes approximately 10 further minutes although there is a break to transport the patient across to the operating suite.
Intervention code [1] 264385 0
Treatment: Surgery
Intervention code [2] 264387 0
Rehabilitation
Comparator / control treatment
Standard Manual Cataract extraction procedure

The standard manual cataract procedure takes approximately 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 266504 0
Primary Outcome:

1. Lens fragmentation is complete. Complete segmentation is achieved without requiring use of ultrasound energy or sharp nuclear crackers.
Timepoint [1] 266504 0
Immediately following surgery
Primary outcome [2] 266654 0
2. Anterior capsulotomy is complete. Complete capsular edge separation without residual tags requiring separation with capsulorhexis style tearing.
Timepoint [2] 266654 0
Immediately post surgery
Primary outcome [3] 266655 0
3. Corneal incision(s) are complete. Entry wounds fully and easily open using a blunt spatula
Timepoint [3] 266655 0
Immediately following surgery
Secondary outcome [1] 273905 0
Safety and incidence of surgical related complications compared to manual surgical procedures.

Surgical complications may include:
Capsular tear
Corneal abrasion or defect
Pain
Infection
Bleeding
Damage to intraocular structures
Anterior chamber fluid leakage, anterior chamber collapse

These complications may occur throughout surgery and will be assessed and treated as required. At 1 day and 3 months following surgery the patient will be seen by the ophthalmologist and assessed on the slit lamp microscope to note the abscence (or presence) of any complications occuring after the initial surgery.
Timepoint [1] 273905 0
at baseline and at 1 and 3 months following surgery
Secondary outcome [2] 276147 0
Efficacy compared to manual cataract removal achieved by assessment of postoperative visual outcomes.

Visual Outcomes include visual acuity both with and without optical aids compared to baseline levels. This will be completed by the use of standard visual acuity charts (Snellen). The patient will also undergo a refraction to assess the level of pre and postoperative prescription. This will further assist the evaluation of the success of the procedures.
Timepoint [2] 276147 0
at baseline and at 1 and 3 months following surgery

Eligibility
Key inclusion criteria
1. Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
2. Subjects must be willing and able to return for scheduled follow-up examinations.
3. Subjects must sign and be given a copy of the written Informed Consent form.
Minimum age
24 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
2. Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
3. Subjects with known sensitivity to planned study concomitant medications.
4. Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
5. Subjects presenting any contraindications to cataract surgery.
6. Hypotony, glaucoma, or the presence of a corneal implant.
7. Presence of blood or other material in the anterior chamber.
8. Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease).
9. A history of lens or zonular instability.

Exclusion For Laser Group Only
10. Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength.
11. Corneal opacity that would interfere with the laser beam.
12. Descemetocele with impending corneal rupture.
13. Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy.
14. Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only).
15. Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape.
16. Corneal thickness requirements that are beyond the range of the system (>1500 microns).

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3378 0
United States of America
State/province [1] 3378 0

Funding & Sponsors
Funding source category [1] 264851 0
Commercial sector/Industry
Name [1] 264851 0
Alcon LenSx
Address [1] 264851 0
33 Journey, Suite 175, Aliso Viejo, CA 92656
Country [1] 264851 0
United States of America
Funding source category [2] 264852 0
Other Collaborative groups
Name [2] 264852 0
Vision Eye Institute
Address [2] 264852 0
Level 3 270 Victoria Avenue
Chatswood NSW 2067
Country [2] 264852 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Vision Eye Institute Chatswood
Address
Level 3 270 Victoria Avenue
Chatswood NSW 2067
Country
Australia
Secondary sponsor category [1] 263952 0
Commercial sector/Industry
Name [1] 263952 0
Alcon LenSx
Address [1] 263952 0
33 Journey, Suite 175, Aliso Viejo, CA 92656
Country [1] 263952 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266816 0
Aspire IRB
Ethics committee address [1] 266816 0
9340 Fuerte Drive, Suite 210 La Mesa CA 91941
Ethics committee country [1] 266816 0
United States of America
Date submitted for ethics approval [1] 266816 0
Approval date [1] 266816 0
Ethics approval number [1] 266816 0
2011-03-144

Summary
Brief summary
The LenSx laser system is a femtosecond laser that has received 510(k) clearance (USA FDA) for anterior capsulotomy during cataract surgery, laser phacofragmentation during cataract surgery and for use in the creation of a single and multi-plan arc cut/incisions in the cornea.

During cataract surgery, the LenSx Laser creates corneal incisions to allow the surgeon to enter the anterior chamber of the eye. It also creates a circular incision on the anterior capsule at a pre-programmed diameter to allow the surgeon to remove the cataractous lens. Lastly, the laser creates incisions within the cataractous crystalline lens to create fragmented pieces that are easy to manipulate, emulsify and aspirate with a phacoemulsification device.

The objective of this study is to observe the performance of the cleared 510(k) device by assessing the laser created anterior capsulotomy, phacofragmentation, and/or corneal incisions when attempted, as well as to compare standard visual outcomes and commercial experience between laser and manual completion of standard cataract surgery procedures.
Trial website
Nil
Trial related presentations / publications
Nil at this point
Public notes

Contacts
Principal investigator
Name 32468 0
Address 32468 0
Country 32468 0
Phone 32468 0
Fax 32468 0
Email 32468 0
Contact person for public queries
Name 15715 0
Chris Hodge
Address 15715 0
Vision Eye Institute Chatswood
Level 3 270 Victoria Avenue
Chatswood NSW 2067
Country 15715 0
Australia
Phone 15715 0
61 2 9424 9999
Fax 15715 0
61 2 9410 3000
Email 15715 0
christopher.hodge@vgaustralia.com
Contact person for scientific queries
Name 6643 0
Chris Hodge
Address 6643 0
Vision Eye Institute Chatswood
Level 3 270 Victoria Avenue
Chatswood NSW 2067
Country 6643 0
Australia
Phone 6643 0
61 2 9424 9999
Fax 6643 0
61 2 9410 3000
Email 6643 0
christopher.hodge@vgaustralia.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary