Cataract
Conditions
Brief summary
The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.
Interventions
DEVICEMonofocal toric IOL
The device under investigation is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens indicated for aphakia after surgical extraction of the cataractous natural lens and is also indicated for the correction of regular corneal astigmatism.
Sponsors
Carl Zeiss Meditec AG
targomedGmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older; * Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits; * Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery; * Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated. * Signed informed consent form; * Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment; * Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps); * Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm; * Clear intraocular media other than cataract.
Exclusion criteria
* Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject; * Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye * Traumatic cataract; * Pregnancy or lactation; * Concurrent participation in another drug or device investigation within the last 30 days; * Irregular astigmatism; * Instability of keratometry or biometry measurements; * Subjects wearing contact lenses as standard vision aid; * Abnormal pupil; * Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.); * History of concurrent intraocular inflammation; * Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies); * History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis; * Pseudoexfoliation syndrome (according to investigator judgement); * Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment; * All kind of infections (acute ocular disease, external / internal infection, systemic infection); * Monophthalmic patient; * Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease * Patient expected to require retinal laser treatment before the end of the last follow-up examination; * Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination; * Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy) * In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refractive predictability | From preoperative visit to the final postoperative visit at twelve months | Difference between predicted Manifest Refraction Spherical Equivalent and achieved Manifest Refraction Spherical Equivalent at the final postoperative visit: Percentage of first implanted eyes within ± 1.0 D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Refractive outcomes | From preoperative visit to the final postoperative visit at twelve months | Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent |
| Refractive predictability | From preoperative visit to the final postoperative visit at twelve months | Percentage of eyes within ± 0.25 D, ± 0.5 D, \& ± 1.0 D |
| Reduction in cylindrical power | From preoperative visit to the final postoperative visit at twelve months | The change in manifest refractive cylinder from baseline to the final postoperative visit. |
| IOL Rotation | From preoperative visit to the final postoperative visit at twelve months | Percentage of IOLs with IOL rotation with less than 10 and 20 degrees. |
| Stability of IOL axis orientation | Between 30 to 60 days and 120 to 180 days | Expressed as percentage of IOLs that rotate ≤ +/- 5 degrees postoperatively |
| Axis Misalignment | From baseline to postoperative visit 120-180 days | The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees. |
| Monocular Uncorrected Distance Visual Acuity (UDVA) | 12-Month Postoperative | — |
| Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better | 12-Months Postoperatively | — |
| Monocular Best-Corrected Distance Visual Acuity (CDVA) | 12-Months Postoperatively | — |
| Monocular Uncorrected Intermediate Visual Acuity (UIVA) | 12-Months Postoperatively | — |
| Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) | 12-Months Postoperatively | — |
| Monocular (1st eye implantations) defocus curve | 12-Months Postoperatively | — |
| Binocular defocus curve on subjects implanted binocularly | 12-Months Postoperatively | — |
| Intraocular Pressure | 12-Months Postoperatively | — |
| Assessment of subject satisfaction, patient reported outcomes, and spectacle independence | 12-Months Postoperatively | — |
| IOL observations | 12-Months Postoperatively | IOL Decentration, Tilt, Discoloration, Opacity, Glistenings |
Countries
Czechia, Germany, Spain, United Kingdom
Contacts
CONTACTGrant Sharpe
CONTACTLinda Villanueva
PRINCIPAL_INVESTIGATORGerd Auffarth, Dr. Med
University Hospital Heidelberg
PRINCIPAL_INVESTIGATORAndrea Janeková, MD, Ph.D
Eye Centre Prague
PRINCIPAL_INVESTIGATORFlorian Kretz, MD
PVK Precise Vision GmbH
PRINCIPAL_INVESTIGATORJiří Pašta, Doc.MUDr
Premium Clinic
PRINCIPAL_INVESTIGATORSatish Srinivasan, M.D
Ayrshire Eye Clinic
PRINCIPAL_INVESTIGATORPedro Tañá, M.D
Oftalmología Vistahermosa S.L
Outcome results
None listed