Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery

NCT06069752 | Completed

• 1 other identifier: KUK-Ophthalmology-003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability. In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Conditions

Ophthalmological Disorder

Outcome Measures

Primary Outcomes (1)

• Tilt and decentration of intraocular lens measured in degrees

  Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery

  1 month post surgery compared with 12 months post surgery

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 50 subjects requiring IOL implantation to treat aphakia after extracapsular cataract extraction or phacoemulsification.

You may qualify if:

• Adult subject with a minimum age of 22 years
• Planned natural lens replacement with posterior chamber IOL implantation
• Clear intraocular media other than cataract
• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
• Ability to consent to the participation in study
• Signed informed consent

You may not qualify if:

• Corneal pathology/ectasia
• Prior ophthalmic surgery
• Zonular-defects, unstable bag
• Macular pathologies
• Expected Visual acuity of less than 0.63 (decimal)
• Glaucoma
• Use of systemic or ocular medication that might affect vision
• Patient is pregnant, plans to become pregnant, is lactating
• Concurrent participation in any other clinical trial with an investigation product

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead
• Carl Zeiss: collaborator

Study Sites (1)

Kepler University Hospital

Linz, Upper Austria, 4021, Austria

Location

Related Publications (1)

• Casazza M, Reifeltshammer SA, Hirnschall N, Mariacher S, Laubichler P, Siska R, Wendelstein J, Bolz M. Randomized controlled bilateral comparison of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. BMJ Surg Interv Health Technol. 2025 Jul 10;7(1):e000342. doi: 10.1136/bmjsit-2024-000342. eCollection 2025.

  PMID: 40662090 DERIVED

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Matthias Bolz, MD

  JKU Linz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: October 6, 2023
• Study Start: March 8, 2022
• Primary Completion: November 22, 2023
• Study Completion: March 31, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)