Axial Stability in Short and Long Eyes After Cataract Surgery (ACDC)

Johannes Kepler University of Linz

Status

Completed

Conditions

Introcular Lens Position

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07210372

JKU-Ophthalmology-002-ACDC

Details and patient eligibility

About

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

Full 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

Enrollment

34 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria