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Trial registered on ANZCTR


Registration number
ACTRN12617001245381p
Ethics application status
Not yet submitted
Date submitted
18/08/2017
Date registered
25/08/2017
Date last updated
25/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective study of vision and centration following an extended depth of focus intraocular lens fixated on the natural lens capsule.
Scientific title
Prospective study after bilateral Femtosecond Laser Assisted Cataract Surgery (FLACS) implantation of rhexis-fixated Extended Depth of Focus Intraocular Lens (EDOF-IOL) to evaluate visual acuity, posterior capsular opacification (PCO) rate and intraocular lens centration. A monocentered Study
Secondary ID [1] 292689 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Cataract 304439 0
Condition category
Condition code
Eye 303772 303772 0 0
Diseases / disorders of the eye
Surgery 303781 303781 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The subject will have previously been diagnosed with cataract requiring surgery for vision rehabilitation.

The FEMTIS IOL medical device details are as follows:
Foldable hydrophilic acrylic Hydrosmart with Plate haptic with 4 additional haptics for capsulorhexis fixation. The IOL is biconvex with anterior segmental near part with +1.5 D addition and posterior aspheric optic with continuous 360° barrier edge. The optic of the lens is 5.7mm extended to 10.5mm including the haptics. The lens is available in power steps from +15 D to +27.0 D in 0.5 diopter increments.

Study procedures
Sutureless cataract surgery will be performed using femtolaser-assisted cataract surgery. Limbal markings at 0° and 180° will be made for all eyes preoperatively with the patient sitting upright and focussing on a distant target. The entire surgical procedure will be performed by the principal investigator of the study. The principal investigator is a fellow of the Royal Australian and New Zealand College of Ophthalmologists with significant experience in conventional and femtosecond laser assisted cataract surgery.

The femtosecond laser will be used for the capsulotomy and may be used for the incisions and the fragmentation of the lens. The lens fragments will be aspirated with standard I/A techniques. The lens will be inserted with the Medicel Viscoject Bio 2.2 injector or a comparable injector with same size and clipped in the capsule opening.

The subject will be required to undergo the following visits.

Day -42 to -1: On the day of pre-operative examination, the patient will undergo a full ophthalmic assessment and routine biometry is performed using optical biometry for axial length measurement and K-readings. This is to determine the most appropriate lens power for the subject's eye. Study specific examinations can be amended before surgery up to Day 0, after the informed consent has been signed at least one day before surgery.

Day 0: Surgery may be performed in topical or general anaesthesia. The self-sealing corneal incision, preparation of the anterior chamber with OVD, irrigation/aspiration of cortical material and injection of OVD into the capsular bag are performed as standard procedures.

Day 1-7, Week 6-8/ Months 6 and 12: Examinations will be performed to determine the visual acuity without glasses, postoperative refraction, lens position and centration. The change over time will be calculated using the postoperative results.


Intervention code [1] 298930 0
Treatment: Devices
Intervention code [2] 298935 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303138 0
The primary outcome variable is IOL de-centration.

IOL centration will be measured intra-operatively using the surgical microscope and at postoperative visits (1 week, 3, 6 and 12 months) using slit lamp biomicroscopy. The subject will be dilated to ensure that the IOL is visible. The surgeon will ensure that consistent head positioning at the slit lamp biomicroscope is obtained prior to an image being taken of the IOL. The (de-identified) image will be sent to the sponsor (Oculentis GMBH) for an objective measurement of IOL centration.

Timepoint [1] 303138 0
1 week and 3, 6 and 12 months following cataract removal and IOL insertion.
Primary outcome [2] 303139 0
Visual acuity (far, intermediate and near)

Measurement of uncorrected and best corrected visual acuity for far distance will be done with ETDRS charts at a distance of 4m. The visual acuity for intermediate and near vision will be evaluate with standardised vision charts for the appropriate test distances at 80 and 40 cm.
Timepoint [2] 303139 0
1 week and 3, 6 and 12 months following cataract removal and IOL insertion.
Primary outcome [3] 303140 0
Defocus IOL curve

At first monocular best corrected subjective refraction for far distance is evaluated with ETDRS charts at a distance of 4m. Afterwards the visual acuity is evaluated bilaterally (both eyes) using a phoropter to place a range of lenses +1.50 dioptres power to -3.00 dioptres with 0.5 dioptre steps. In order to exclude a bias of the patient, the change of different chart optotypes is recommended for the measurements for every 0.5 dioptre step. The lowest line (including number of letters) at each lens power is recorded.

Timepoint [3] 303140 0
1 week and 3, 6 and 12 months following cataract removal and IOL insertion.
Secondary outcome [1] 338012 0
Subjective refraction

Subjective refraction will be assessed using trial lenses and the cross cylinder method. These measurements are non-invasive, non-contact and readily used in daily clinical practice. Subjective refraction will be determined by an experienced examiner.
Timepoint [1] 338012 0
1 week and 3, 6 and 12 months following cataract removal and IOL insertion.
Secondary outcome [2] 338033 0
Posterior Capsular Opacification (PCO)

PCO will be measured via slit lamp biomicroscopy examination which will be performed by an experienced examiner and recorded via standard available classification in the subject file.
Timepoint [2] 338033 0
1 week and 3, 6 and 12 months following cataract removal and IOL insertion.

Eligibility
Key inclusion criteria
• Cataract
• Patient age of greater than 30 years
• Postoperative emmetropia is intended
• IOL power between +15 Dioptres and +27 Dioptres
• Expected postop. corneal astigmatism less than 0.75 dioptres
• Pupil size greater than 2.8 mm
• Preoperative pupil de-centration less than 0.8 mm (Center Shift)
• Bilateral treatment
• Wearer of contact lenses need to observe a 2 week waiting period without lens
• Written consent of the patient
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any of the following will exclude a subject from the study:
• Amblyopia
• Strabismus
• Zonulolysis
• Keratoplasty
• Insulin-dependent diabetes
• Previous refractive surgery or glaucoma surgery
• Subjects with ocular disorders, other than cataract, that could potentially
cause future acuity losses to a level 0.3 logMAR or worse in either eye
• Current participation of patient in other clinical trial

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Visual and biometric parameters will be compared to existing literature

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2017
Actual
Date of last participant enrolment
Anticipated
1/03/2018
Actual
Date of last data collection
Anticipated
1/03/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16960 0
2022 - Bondi Junction

Funding & Sponsors
Funding source category [1] 297330 0
Commercial sector/Industry
Name [1] 297330 0
Oculentis GmbH
Country [1] 297330 0
Germany
Primary sponsor type
Individual
Name
Dr Patrick Versace
Address
Vision Eye Institute Bondi Junction
Level 2, 59-75 Grafton Street
Bondi Junction, NSW 2022
Country
Australia
Secondary sponsor category [1] 296304 0
Commercial sector/Industry
Name [1] 296304 0
Oculentis GmbH
Address [1] 296304 0
Am Borsigturm 58
13507 Berlin
Country [1] 296304 0
Germany

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298432 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 298432 0
University of New South Wales Research Ethics & Compliance Support
The University of New South Wales
Level 3, Rupert Myers Building (South Wing)
Anzac Parade, Kensington, New South Wales 2033
Australia
Ethics committee country [1] 298432 0
Australia
Date submitted for ethics approval [1] 298432 0
25/08/2017
Approval date [1] 298432 0
Ethics approval number [1] 298432 0

Summary
Brief summary
With increasing demands of patients concerning their refractive outcome after cataract surgery, a variety of advanced technology intraocular lenses have become available in the last years. The modifications include advanced optic designs, improved haptic materials and designs and combinations of both.

A new era of cataract surgery has entered the market recently, the femtolaser-assisted cataract surgery (FLACS). This advanced technique replaces various steps of cataract surgery which had to been done manually or by ultrasound devices. The femtolaser can do highly precise incisions for access to the crystalline lens which needs to be replaced in cataract patients. The capsulorrhexis, the manual opening of the capsular bag can be replaced by a high precision capsulotomy with the laser. Furthermore, many FLACS devices can divide the opaque natural lens in mini-fragments which can easily be aspirated afterwards. This step was traditionally performed with phacoemulsification using ultrasound. Furthermore, the correction of mild astigmatism by arcuate incisions can be performed with these types of laser which was done manually, based on nomograms, before.

Major advantages of FLACS are the improved ability of planning and controlling incisions and capsulotomy, the higher precision with regards to size and shape and the lower amount of energy induced in the eye, compared with ultrasound phacoemulsification.

In parallel to the development of the FLACS technology a new lens type has been developed: the FEMTIS. The highly precise execution of the laser allows to exactly predict the size and position of the capsulotomy. The FEMTIS has been designed to be locked in place in the opening of the capsule. In traditional lens implantation, the IOL was placed in the capsular bag and kept in place by the back-pressure of the capsule against the haptics. Capsular shrinkage and fibrosis increases the pressure on the haptics which can lead to decentration, tilt and rotation of the lens, resulting in induced higher order aberrations which decrease the optical quality of the visual system. If a lens, like the FEMTIS is locked in place in the capsular bag opening, IOL decentration, tilt and rotation should be minimized, which should result in a higher predictability and refractive precision. In this study we will investigate the stability of lens position and the visual outcome after implantation of the new FEMTIS® Comfort using FLACS capsulotomy.
The FEMTIS® Comfort is a rotational asymmetric refractive lens with a sector-shaped IOL part providing an addition of 1.5 dioptres. The extended depth of focus should effected a higher visual acuity for far and intermediate distances with greater spectacle independence.
Trial website
Trial related presentations / publications
Not available at time of submission
Public notes

Contacts
Principal investigator
Name 77066 0
Dr Patrick Versace
Address 77066 0
Vision Eye Institute Bondi Junction
Level 2, 59-75 Grafton Street
Bondi Junction, NSW 2022
Country 77066 0
Australia
Phone 77066 0
+612 93863666
Fax 77066 0
+612 9386 3699
Email 77066 0
[email protected]
Contact person for public queries
Name 77067 0
Chris Hodge
Address 77067 0
Vision Eye Institute
Level 2, 59-75 Grafton Street
Bondi Junction, NSW 2022
Country 77067 0
Australia
Phone 77067 0
+612 93863666
Fax 77067 0
+612 93863699
Email 77067 0
[email protected]
Contact person for scientific queries
Name 77068 0
Chris Hodge
Address 77068 0
Vision Eye Institute
Level 2, 59-75 Grafton Street
Bondi Junction, NSW 2022
Country 77068 0
Australia
Phone 77068 0
+612 93863666
Fax 77068 0
+612 93863699
Email 77068 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23555Clinical study report https://pubmed.ncbi.nlm.nih.gov/32126029 
23556OtherJ Cataract Refract Surg. 2020 Feb;46(2):179-187. Visual performance and positional stability of a capsulorhexis-fixated extended depth-of-focus intraocular lens DOI: 10.1097/j.jcrs.0000000000000044https://pubmed.ncbi.nlm.nih.gov/32126029/  

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 373502-(Uploaded-29-07-2020-07-33-53)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.