h25 H26.0 H52.2
Conditions
Interventions
Group 1: Cataract surgery and IOL alignment supported by CALLISTO eye.
Group 2: Cataract surgery using a Mendez-Ring as marking method to align the IOL (Control group).
Sponsors
Carl Zeiss Meditec AG - Site Munich
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Uncorrected Distance Vision (UCDV) before surgery, and at 1 week and 6 weeks after surgery 2.Toric IOL decentration in mm, both horizontally and vertically 3.Toric IOL axis deviation (in degrees): i.e. the actual axis marker orientation minus the intended, target axis. 4.Difference between the intended (target) and post-operative rhexis diameter, and symmetry 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
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects with operative conjunctival haemorrhages and/or conjunctival ballooning 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. 3. Clinical applicability and descriptive appraisal of all the intra-operative guidance system CALLISTO eye. | — |
Countries
United Kingdom
Contacts
Public ContactRuth Craven
Visioncare Research Ltd.
Outcome results
None listed