Evaluation of An Intra-Operative Toric Intraocular Lens Alignment System
- Conditions
- h25H26.0H52.2Senile cataractInfantile, juvenile and presenile cataractAstigmatism
- Registration Number
- DRKS00005051
- Lead Sponsor
- Carl Zeiss Meditec AG - Site Munich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 71
•Cataract, for which phacoemulsification and posterior chamber IOL implantation has been planned in the operative eye OR.
•Clear crystalline lens, for which the subject has elected to undergo ‘refractive lens exchange’, with planned phacoemulsification and posterior chamber IOL implantation in the operative eye.
•Patient age = 21 years.
•Pre-operative corneal astigmatism =1.00 D
•The subject must be able to provide written Informed Consent.
•The subject must be able to return for the scheduled follow up examinations one week and six weeks after surgery.
•Normal anterior and posterior segments.
•Clear intraocular media – other than cataract.
•Corneal ectasia* (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
•Peripheral corneal thinning disorders* (e.g. Mooren’s Ulcer or Terrien’s marginal degeneration)
•Any forms of corneal pathology potentially affecting topography.
•Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)*.
•Subjects with diagnosed degenerative visual disorders * (for example macular degeneration or any other retinal disorders) that are predicted to cause future acuity losses.
•Capsular/zonular lens abnormalities* that may affect post-operative IOL centration and/or tilt
•Microphthalmia*.
•Active ocular disease*, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch’s endothelial dystrophy).
•Cornea dystrophy*, guttata* or oedema*.
•Previous corneal graft/keratoplasty.
•Pre-operative visual acuity* below +1.00 logMAR (6/60 Snellen)
•Subjects with any systemic disease* that could increase operative risk or confound the outcome
•Previous history of ocular inflammation.
•Subjects using any systemic medication(s) known to cause ocular side effects which may adversely affect the subjects acuity.
•Subjects who have only one eye with potentially good vision.
•Pre-operative Keratoconjunctivitis Sicca*
•Pupil dilation is not possible*
•Patients who are pregnant or lactating or planning a pregnancy at the time of enrolment.
•Subjects participating in a concurrent clinical trial or if they have participated in a clinical trial within the last 30 days.
*) Exclusion criteria, if evident in the operative eye.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Uncorrected Distance Vision (UCDV) before surgery, and at 1 week and 6 weeks after surgery<br><br>2.Toric IOL decentration in mm, both horizontally and vertically<br><br>3.Toric IOL axis deviation (in degrees): i.e. the actual axis marker orientation minus the intended, target axis. <br><br>4.Difference between the intended (target) and post-operative rhexis diameter, and symmetry <br><br>All outcome parameters are determined 1 week and 6 weeks after the IOL implantation. The measurement is performed with a digital slit lamp and a digital image analysis program.
- Secondary Outcome Measures
Name Time Method 1.Percentage of subjects with operative conjunctival haemorrhages and/or conjunctival ballooning<br>2.Workflow time (the time from making the opening incision, to the time at the closing of the incision) measured using the CALLISTO device: the workflow time will be determined for both the study and control groups. <br>3.Clinical applicability and descriptive appraisal of all the intra-operative guidance system CALLISTO eye.<br>