None listed
Conditions
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.
Interventions
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 a
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.
Sponsors
Dr Patrick Versace
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed