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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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Post operative intraocular lens position is being measured after cataract surgery in 34 patients with long and short eyes.
Prediction of the post-operative IOL position in long and short eyes the prediction difficult. Therefore, it is relevant to evaluate the post-operative IOL position in patients with an axial eye length outside the typical range. This study will help to improve the prediction of the post-operative refractive outcome in short and long eyes after implantation of a Clareon IOL. Therefore, three different OCT based measurements will be used (IOLMaster700, CZM; CASIA II, Tomey; SM-39, CSO), respectively. Post-operatively, these measurements will be repeated 1 hour, 1 week, and 12 weeks after surgery.
Hypothesis: Implantation of the Clareon IOL leads to a stable post-operative IOL position in short (≤22.75mm) and long (≥25.50mm) eyes.
Endpoints:
Primary Endpoint: change in anterior chamber depth (=IOL position) in mm from 1 week to 12 weeks post-operative visit for both short and long eyes (two separate analysis) (Refraction will be a secondary outcome due to its larger variability compared to ACD measurements 1)
Secondary Endpoint:
Refractive outcome after Clareon IOL implantation at 1- and 12-week visit o
Monocular BCDVA and DCIVA (66cm) at 1 week and 12-week post-operative visit
o Subjects with a post operative tilt (at 12-week post operative visit) ≥10⁰ will be excluded from VA analysis
Change in ACD in mm from 1 hour to 12 weeks, 1 hour to 1-week post-op visit for both short and long eyes Exploratory Endpoints
Comparison of refractive outcome between long and short eyes via prediction error for Barret Universal II for long eyes and Kane formula for short eyes with target emmetropia to -2.50D based on subject's visual needs ACD in mm 1 hour, 1 week, and 12 weeks post op as measured from corneal epithelium to anterior lens surface by IOL master 700, Casia II, and MS 39
Principal Objective: Aim of this study is to measure the change in the post-operative Anterior Chamber Depth of the Clareon monofocal IOL in short/long eyed patients at different post operative time points (1 hour, 1 week, and 12 weeks) during uneventful FLACS cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short eye | patients with eye length up to 22,75mm | ||
| long eye | patients with eye length at least 25,50mm |
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| Measure | Description | Time Frame |
|---|---|---|
| change in anterior chamber depth | change in anterior chamber depth in millimeter | 1 week and 12 weeks post operative |
| Measure | Description | Time Frame |
|---|---|---|
| refractive outcome after intraocular lens implantation | spherical equivalent | 1 week and 12 weeks post operative |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergoing planned cataract surgery
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| Name | Affiliation | Role |
|---|---|---|
| Nino Hirnschall, MD | Kepler Universitätsklinikum /JKU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler University Clinic, Linz | Linz | 4020 | Austria |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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