NCT07210372

Axial Stability in Short and Long Eyes After Cataract Surgery

Post-Operative Axial Stabilty in Short and Long Eyes After Implanation of a Clareon Intraocular Lens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Johannes Kepler University of Linz · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

Summary

Post operative intraocular lens position is being measured after cataract surgery in 34 patients with long and short eyes.

Detailed description

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. * Exploratory/secondary Objectives: * To measure post-operative monocular corrected visual acuity of the Clareon IOL at distance and intermediate vision (66cm) * To Compare refractive outcomes between long and short eyes

Conditions

• Introcular Lens Position

Timeline

• Start date: 2023-12-04
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2025-10-07
• Last updated: 2025-10-07

Locations

1 site across 1 country: Austria