Axial Stability in Short and Long Eyes After Cataract Surgery

NCT ID: NCT07210372

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2025-01-10

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

short eye

patients with eye length up to 22,75mm

No interventions assigned to this group

long eye

patients with eye length at least 25,50mm

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• bilateral cataract surger
• axial eye length below 22,75mm or above 25.50mm

Exclusion Criteria

• ocular pathologies that could lead to an unstable capsular bag
• pregnancy
• preoperative visual acuity above 1.0logMar

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Johannes Kepler University of Linz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nino Hirnschall, MD

Role: PRINCIPAL_INVESTIGATOR

Kepler Universitätsklinikum /JKU

Locations

Kepler University Clinic, Linz

Linz, , Austria

Countries

Austria

Other Identifiers

JKU-Ophthalmology-002-ACDC

Identifier Type: -

Identifier Source: org_study_id